AXSM Jul 7, 2026AXSMPhases
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Axsome Therapeutics Initiates FOCUS-2 Phase 3 Trial of Solriamfetol in Children with Attention Deficit Hyperactivity Disorder (ADHD)
Axsome Therapeutics has commenced the FOCUS-2 Phase 3 trial for solriamfetol, targeting children aged 6 to under 12 with ADHD. This trial follows the FOCUS-3 trial for adolescents and aims to evaluate the drug's efficacy and safety. Approximately 468 children will participate, with results expected to contribute to ADHD treatment advancements.
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AXSM Jun 26, 2026AXSMPhases
Axsome Therapeutics Initiates FOCUS-3 Phase 3 Trial of Solriamfetol in Adolescents with Attention Deficit Hyperactivity Disorder (ADHD)
Axsome Therapeutics has commenced the FOCUS-3 Phase 3 trial for solriamfetol, targeting adolescents aged 12 to under 18 with ADHD. This randomized, double-blind study will evaluate the drug's efficacy and safety over six weeks, with 468 participants receiving either solriamfetol or a placebo. The primary measure will be the change in ADHD symptoms as assessed by the ADHD Rating Scale.
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AXSM Jun 18, 2026AXSMGeneral
Axsome Therapeutics Highlights the Importance of Brain Health During Alzheimer's & Brain Awareness Month
Axsome Therapeutics is emphasizing the importance of brain health during Alzheimer's & Brain Awareness Month. The company is collaborating with patients, caregivers, and advocacy organizations to promote awareness and provide resources. They will participate in over 30 events aimed at ending Alzheimer's and will illuminate their headquarters in purple to support the cause.
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AXSM Jun 15, 2026AXSMConferences/Events
Axsome Therapeutics Presents New Data Highlighting its Innovative Sleep Medicine Portfolio at SLEEP 2026
Axsome Therapeutics presented new data on its sleep medicine portfolio at SLEEP 2026, highlighting AXS-12 and solriamfetol. The presentations included findings from Phase 3 trials and analyses related to narcolepsy and excessive daytime sleepiness. The event showcased the company's commitment to advancing treatments for central nervous system disorders.
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AXSM Jun 4, 2026AXSMConferences/Events
Axsome Therapeutics Presents New SYMBRAVO Data at the Americal Headache Society (AHS) 68th Annual Scientific Meeting
Axsome Therapeutics announced the presentation of new data on SYMBRAVO at the American Headache Society's 68th Annual Scientific Meeting. The presentations, occurring between June 4-7 in Orlando, cover various analyses related to the acute treatment of migraines using SYMBRAVO. Notable authors from respected institutions will lead these discussions, which focus on efficacy and comparisons to other migraine treatments. This meeting represents a significant exposure for Axsome's migraine therapy.
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AXSM Jun 3, 2026AXSMFDA Updates
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Axsome Therapeutics Announces Settlement Resolving All SUNOSI® (solriamfetol) Patent Litigation
Axsome Therapeutics has successfully settled all patent litigation concerning its product SUNOSI (solriamfetol). The settlement permits five companies to sell generic versions of SUNOSI starting in 2040, subject to FDA approval. This resolution eliminates any remaining patent disputes related to SUNOSI, allowing Axsome to focus on its broader business objectives.
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AXSM Jun 1, 2026AXSMGeneral
Axsome Therapeutics Partners with the Headache Alliance to Highlight the Impact of Migraine During Migraine and Headache Awareness Month
Axsome Therapeutics is enhancing its commitment to the migraine community by supporting educational initiatives during Migraine and Headache Awareness Month. The company is backing the Headache in the City campaign and illuminating its headquarters in purple to raise awareness. This effort aims to reduce stigma and improve understanding of migraine's impact on millions.
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AXSM May 27, 2026AXSMConferences/Events
Axsome Therapeutics to Participate in Upcoming Investor Conferences
Axsome Therapeutics, Inc. (NASDAQ: AXSM) has announced its participation in several investor conferences scheduled for June 2026. The company will engage in fireside chats at major events, including the William Blair and Jefferies Global Healthcare Conferences. Webcasts of these presentations will be available on the company's website, promoting transparency for investors. The participation aims to strengthen relationships with the investment community and showcase its advancements in treating CNS disorders.
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AXSM May 26, 2026AXSMConferences/Events
Axsome Therapeutics Presents New AUVELITY® Data in Major Depressive Disorder at the American Society of Clinical Psychopharmacology (ASCP) 2026 Annual Meeting
Axsome Therapeutics has announced new data presentations on AUVELITY® for major depressive disorder at the ASCP 2026 Annual Meeting. The presentations will cover various aspects of the treatment, including its effects and real-world clinical outcomes. The event is set to take place from May 26-29 in Miami, FL, showcasing advancements in CNS disorder treatments.
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AXSM May 7, 2026AXSMGeneral
Axsome Therapeutics Recognizes Mental Health Month
Axsome Therapeutics is recognizing Mental Health Month by supporting initiatives aimed at improving mental health awareness and providing resources for individuals affected by mental health conditions. The company emphasizes the importance of community support and highlights various organizations that offer educational tools and assistance. This year's theme, 'More Good Days, Together,' focuses on fostering hope and recovery for those impacted by mental illness.
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AXSM May 4, 2026AXSMGeneral
▲ +8.3%on this newsshared move
Axsome Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update
Axsome Therapeutics reported a strong financial performance for Q1 2026, with total net product revenue reaching $191.2 million, a 57% increase from the previous year. The company highlighted the FDA approval of AUVELITY for treating agitation associated with Alzheimer's disease and the expansion of its product pipeline. Despite these successes, Axsome recorded a net loss of $64.5 million due to rising operational costs.
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AXSM May 1, 2026AXSMFDA Updates
Axsome Therapeutics Hosts AUVELITY® FDA Approval Investor Event Featuring Expert Thought Leader
Axsome Therapeutics has announced the FDA approval of AUVELITY for treating agitation associated with Alzheimer's disease. The company hosted a virtual investor event featuring Dr. Jeffrey Cummings, who discussed the significance of this first-in-class treatment. AUVELITY targets NMDA and sigma-1 receptors and is expected to enhance patient outcomes in managing agitation in dementia.
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AXSM Apr 30, 2026AXSMFDA Updates
▲ +12.9%on this newsshared move
Axsome Therapeutics Announces FDA Approval of AUVELITY (dextromethorphan HBr and bupropion HCl) for the Treatment of Agitation Associated with Dementia due to Alzheimer's Disease AUVELITY is a first-in-class treatment, w
Axsome Therapeutics has received FDA approval for AUVELITY, a first-in-class treatment for agitation associated with dementia due to Alzheimer's disease. This medication targets NMDA and sigma-1 receptors and addresses a significant unmet need among Alzheimer's patients, with agitation affecting up to 76% of this population. The approval follows comprehensive clinical studies demonstrating its effectiveness and safety profile, enabling a much-needed treatment option for patients and their caregivers. AUVELITY is also noted for its distinct mechanism of action compared to existing therapies.
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AXSM Apr 8, 2026AXSMConferences/Events
Axsome Therapeutics to Report First Quarter 2026 Financial Results on May 4
Axsome Therapeutics announced it will report its first quarter 2026 financial results on May 4, 2026. The company will host a conference call at 8:00 a.m. ET to discuss these results and provide a business update. Investors can participate via phone or a live webcast on the company's website.
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AXSM Apr 1, 2026AXSMGeneral
Axsome Therapeutics Acquires Selective PDE10A Inhibitor Balipodect for the Treatment of Schizophrenia and Other Neuropsychiatric Conditions Axsome obtains exclusive global rights to balipodect, a potentially first-in-cla
Axsome Therapeutics has acquired exclusive global rights to balipodect, a selective phosphodiesterase 10A inhibitor, aimed at treating schizophrenia and Tourette syndrome. The company plans to initiate Phase 3 trial-enabling activities for schizophrenia in 2026. Balipodect has previously shown a favorable safety profile in clinical trials involving over 360 people. This acquisition further positions Axsome's neuroscience pipeline as it seeks to address significant unmet needs in neuropsychiatric conditions.
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AXSM Feb 24, 2026AXSMPhases
Axsome Therapeutics Initiates CLARITY Phase 3 Trial of Solriamfetol in Adults with Major Depressive Disorder with Excessive Daytime Sleepiness Symptoms
Axsome Therapeutics has initiated the CLARITY Phase 3 trial for solriamfetol, targeting adults with major depressive disorder (MDD) who experience excessive daytime sleepiness (EDS). The trial will assess the efficacy of solriamfetol in preventing relapse of depressive symptoms. This study addresses a significant gap in treatment options for MDD with EDS, a condition affecting many patients.
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AXSM Feb 23, 2026AXSMGeneral
Axsome Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update
Axsome Therapeutics reported strong financial results for Q4 and full year 2025, highlighting commercial momentum and advancements in its CNS pipeline. The company anticipates significant regulatory actions and clinical milestones in 2026, including potential FDA approval for AXS-05 in Alzheimer's disease agitation and NDA filing for AXS-12 in narcolepsy. The pipeline now includes five differentiated product candidates.
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AXSM Feb 18, 2026AXSMConferences/Events
Axsome Therapeutics to Present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference
Axsome Therapeutics will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25, 2026. The presentation will be accessible via a live webcast, with a replay available for 30 days. The company is recognized for its innovative approach to treating CNS disorders and has several FDA-approved treatments.
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AXSM Feb 17, 2026AXSMFDA Updates
Axsome Therapeutics Settles SUNOSI® (solriamfetol) Patent Litigation with Alkem Laboratories Ltd.
Axsome Therapeutics has settled patent litigation with Alkem Laboratories concerning SUNOSI (solriamfetol). The agreement permits Alkem to sell a generic version starting in 2040, contingent on pediatric exclusivity. The settlement is subject to review by federal authorities. Axsome continues to pursue other patent litigation related to SUNOSI.
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AXSM Jan 27, 2026AXSMConferences/Events
Axsome Therapeutics to Report Fourth Quarter and Full Year 2025 Financial Results on February 23
Axsome Therapeutics will announce its financial results for Q4 and full year 2025 on February 23, 2026. A conference call will follow at 8:00 a.m. ET for discussion and updates. The company is recognized for its innovative CNS treatments and has a robust pipeline addressing various neurological conditions.
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AXSM Jan 16, 2026AXSMPhases
Axsome Therapeutics Initiates FORWARD Phase 3 Trial of AXS-14 for the Management of Fibromyalgia
Axsome Therapeutics has commenced the FORWARD Phase 3 trial of AXS-14 for fibromyalgia management, marking a crucial step in addressing this chronic condition. The trial will evaluate the drug's effectiveness through a randomized withdrawal design, with patients initially receiving open-label treatment. The study aims to assess the time to loss of therapeutic response, providing valuable insights into AXS-14's potential benefits.
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AXSM Jan 12, 2026AXSMGeneral
Axsome Therapeutics Provides Preliminary Fourth Quarter and Full Year 2025 Net Product Revenue Total preliminary 4Q and full year 2025 net product revenue of $196.0 million and $638.5 million, respectively, representing
Axsome Therapeutics has released preliminary estimates for its fourth quarter and full year 2025 net product revenues, predicting totals of $196 million and $638.5 million, respectively, marking approximately 65% and 66% growth year-over-year. Significant contributions to these revenues are expected from AUVELITY, SUNOSI, and SYMBRAVO, with AUVELITY alone projected to generate $155.1 million in Q4. While these figures present an optimistic outlook, they are based on unaudited information and subject to revision upon completion of the financial closing procedures.
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AXSM Jan 1, 2026AXSMFDA Updates
Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-12 in Narcolepsy Supporting NDA Submission
Axsome Therapeutics has received formal pre-NDA meeting minutes from the FDA, supporting its upcoming NDA submission for AXS-12, a treatment for narcolepsy. The company plans to submit the NDA in January 2026, with the FDA's feedback indicating that their regulatory data package is sufficient. AXS-12 has been granted Orphan Drug Designation, which may provide marketing exclusivity upon approval.
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AXSM Jan 1, 2026AXSMFDA Updates
Axsome Therapeutics Announces FDA Acceptance and Priority Review of Supplemental New Drug Application for AXS-05 for the Treatment of Alzheimer’s Disease Agitation
Axsome Therapeutics announced that the FDA has accepted its supplemental NDA for AXS-05, aimed at treating agitation in Alzheimer's disease, and granted it Priority Review status. This designation allows for a faster review process, with a PDUFA target action date set for April 30, 2026. The drug addresses a critical need, as agitation affects up to 76% of Alzheimer's patients.
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AXSM Nov 6, 2025AXSMGeneral
Axsome Therapeutics Acquires Subtype Selective GABA-A Receptor Positive Allosteric Modulator AZD7325 for the Treatment of Epilepsy
Axsome Therapeutics has secured exclusive global rights to AZD7325, a novel GABAA receptor positive allosteric modulator, from AstraZeneca. This acquisition aims to expand Axsome's portfolio in treating epilepsy, with plans to initiate Phase 2 trial-enabling activities in 2026. AZD7325 has shown anti-convulsant effects and a favorable safety profile in prior studies.
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AXSM Nov 3, 2025AXSMGeneral
Axsome Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update
Axsome Therapeutics reported a strong financial performance for Q3 2025, with net product revenue reaching $171 million, a 63% increase from the previous year. The company's flagship product, AUVELITY, generated $136.1 million in sales, marking a 69% year-over-year growth. Additionally, Axsome submitted a supplemental NDA for AXS-05 targeting Alzheimer's disease agitation, highlighting its robust pipeline and commitment to addressing unmet medical needs.
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AXSM Oct 9, 2025AXSMGeneral
Axsome Therapeutics Recognizes Mental Illness Awareness Week Along with the National Advocacy Community
Axsome Therapeutics is recognizing Mental Illness Awareness Week in collaboration with national mental health advocacy groups, including NAMI. This year's theme focuses on community support for mental well-being. The company highlights the significant impact of mental health conditions in the U.S. and shares resources to aid those affected. Axsome remains committed to improving mental health through innovative treatments and community partnerships.
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AXSM Oct 7, 2025AXSMGeneral
Axsome Therapeutics to Report Third Quarter 2025 Financial Results on November 3
Axsome Therapeutics announced it will report its financial results for the third quarter of 2025 on November 3, 2025, prior to the U.S. market opening. Following the report, the company will hold a conference call at 8:00 a.m. Eastern Time to discuss the results and provide an update on its business. Interested parties can access the webcast on the company's website, with a replay option available for 30 days thereafter.
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AXSM Sep 17, 2025AXSMConferences/Events
Axsome Therapeutics Highlights Data Across Its Leading Neuroscience Pipeline at Psych Congress 2025
Axsome Therapeutics presented six key topics at Psych Congress 2025, focusing on major CNS disorders such as Major Depressive Disorder and Alzheimer's Disease Agitation. The event, held in San Diego, showcases the company's innovative neuroscience products and ongoing commitment to improving patient outcomes. Their portfolio includes FDA-approved treatments and late-stage development programs.
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AXSM Aug 4, 2025AXSMGeneral
Axsome Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update Total 2Q 2025 net product revenue of $150.0 million, representing growth of 72% year-over-year and 24% sequentially AUVELITY
Axsome Therapeutics reported robust financial results for the second quarter of 2025, with total net product revenue of $150 million, reflecting a 72% year-over-year growth. AUVELITY, the company's rapid-acting oral treatment for major depressive disorder, generated $119.6 million in sales, marking an 84% increase compared to the previous year. The company also expanded its market access for AUVELITY, adding 28 million new lives covered. However, despite significant revenue growth, Axsome faced a net loss of $48 million for the quarter, primarily attributed to high operating costs.
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AXSM Jul 21, 2025AXSMConferences/Events
Axsome Therapeutics Hosts Frontiers in Brain Health R&D Day Reviewing Industry-Leading Late-Stage CNS Pipeline
Axsome Therapeutics hosted its Frontiers in Brain Health R&D Day in New York City, showcasing its advanced pipeline targeting CNS disorders such as Alzheimer's disease, depression, and ADHD. The event featured presentations from leading clinicians and key opinion leaders discussing clinical data and treatment advancements. The webcast is available for institutional investors and analysts.
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AXSM Jul 21, 2025AXSMGeneral
Axsome Therapeutics to Ring the NASDAQ Stock Market Opening Bell Today
Axsome Therapeutics will ring the NASDAQ opening bell on July 21, 2025, to celebrate its Frontiers in Brain Health R&D Day. CEO Herriot Tabuteau emphasized the company's innovative CNS product pipeline and the recent launch of SYMBRAVO. The ceremony will take place at the Nasdaq MarketSite in Times Square, New York.
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AXSM Jul 9, 2025AXSMGeneral
Axsome Therapeutics to Report Second Quarter 2025 Financial Results on August 4
Axsome Therapeutics, a biopharmaceutical company specializing in CNS disorders, will announce its financial results for Q2 2025 on August 4. The results will be shared before the U.S. markets open, followed by a conference call at 8:00 a.m. Eastern Time. Interested participants can join via phone or access a live webcast on the company's website. A replay will also be available for approximately 30 days post-event.
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AXSM Jul 7, 2025AXSMConferences/Events
Axsome Therapeutics to Showcase Its Innovative CNS Pipeline at Upcoming Frontiers in Brain Health R&D Day in New York City on July 21
Axsome Therapeutics will host its Frontiers in Brain Health R&D Day in New York City on July 21, 2025. The event aims to highlight the company's late-stage pipeline in treating central nervous system disorders. Key opinion leaders will discuss ongoing clinical development programs, and Axsome's management will provide insights into their initiatives. This event is specifically for institutional investors and sell-side analysts, and registration is required due to limited space.
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AXSM Jun 20, 2025AXSMGeneral
Axsome Therapeutics Champions Brain Health During Alzheimer's & Brain Awareness Month
Axsome Therapeutics is highlighting the importance of brain health in collaboration with the Alzheimer’s disease advocacy community during Alzheimer's & Brain Awareness Month. With over 7 million Americans diagnosed with Alzheimer's disease, the initiative aims to raise awareness and share resources related to brain health. The campaign emphasizes the potential for improving cognitive health through lifestyle changes, such as good sleep and exercise, while also recognizing the increasing burden of Alzheimer’s on public health.
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AXSM Jun 18, 2025AXSMConferences/Events
Axsome Therapeutics to Present Data Spanning the SYMBRAVO (meloxicam and rizatriptan) Clinical Program at the 67th Annual Scientific Meeting of the American Headache Society (AHS)
Axsome Therapeutics announced that it will present data from its SYMBRAVO clinical program at the upcoming 67th Annual Scientific Meeting of the American Headache Society in Minneapolis. The presentations will feature various studies related to the efficacy and long-term effects of SYMBRAVO, which combines meloxicam and rizatriptan for migraine treatment. Notable presentations include findings from the INTERCEPT and MOVEMENT trials, highlighting the treatment's impact on migraine-associated disability and quality of life.
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AXSM Jun 16, 2025AXSMGeneral
Axsome Therapeutics Proudly Supports Migraine and Headache Awareness Month Alongside the Association of Migraine Disorders
Axsome Therapeutics is recognizing Migraine and Headache Awareness Month by supporting various events across the U.S. and providing resources for patients affected by migraines. The initiative is aligned with the theme 'Your Path to Better Days', aiming to raise awareness and provide education about migraine disorders. Migraine affects approximately 40 million people in the U.S. and remains a leading cause of disability worldwide. The company's participation, along with the Association of Migraine Disorders, illustrates its commitment to improving the understanding and treatment of this debilitating condition.
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AXSM Jun 11, 2025AXSMConferences/Events
Axsome Therapeutics Showcases Innovation in Sleep Medicine with Multiple Presentations for AXS-12 and Solriamfetol at SLEEP 2025
Axsome Therapeutics Showcases Innovation in Sleep Medicine with Multiple Presentations for AXS-12 and Solriamfetol at SLEEP 2025
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AXSM Jun 10, 2025AXSMFDA Updates
Axsome Therapeutics Announces Availability of SYMBRAVO (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults SYMBRAVO represents a novel multi-mechanistic approach to treating mig
Axsome Therapeutics has launched SYMBRAVO, a novel oral medication combining meloxicam and rizatriptan, for the acute treatment of migraines with or without aura in adults. This medication is noted for its rapid efficacy, allowing patients to achieve pain freedom within two hours. SYMBRAVO is supported by comprehensive patient services to enhance accessibility. However, the treatment carries potential risks, including cardiovascular issues and other serious side effects.
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AXSM Jun 9, 2025AXSMFDA Updates
Axsome Therapeutics Provides Update on the New Drug Application (NDA) for AXS-14 for the Management of Fibromyalgia
Axsome Therapeutics announced that it received a Refusal to File (RTF) letter from the FDA regarding its NDA for AXS-14 aimed at fibromyalgia management. The FDA cited incompleteness of the submission, specifically noting that one of the trials was inadequate. Axsome will conduct an additional controlled trial to address this feedback, anticipating to initiate this trial by late 2025. Despite the RTF, the FDA acknowledged positive results from the other trial, providing a pathway for further development of AXS-14.
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AXSM May 28, 2025AXSMConferences/Events
Axsome Therapeutics Presents Data from Three of Its Innovative Neuroscience Programs at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting
Axsome Therapeutics, Inc. recently presented findings from three neuroscience programs at the ASCP 2025 Annual Meeting in Scottsdale, Arizona. The studies focused on AUVELITY for major depressive disorder, AXS-05 for agitation in Alzheimer's, and solriamfetol for excessive daytime sleepiness in narcolepsy. Notably, AUVELITY has obtained Breakthrough Therapy designation from the FDA, highlighting its potential impact in treating MDD. Each presentation featured expert insights and emphasized significant findings that could influence future treatment protocols.
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AXSM May 27, 2025AXSMGeneral
Axsome Therapeutics Settles SUNOSI (solriamfetol) Patent Litigation with Hetero Labs Ltd.
Axsome Therapeutics has reached a settlement with Hetero Labs regarding patent litigation related to its product SUNOSI (solriamfetol). The agreement allows Hetero to sell a generic version of SUNOSI starting in March or September 2040, contingent upon pediatric exclusivity and FDA approval. This resolution comes as Axsome continues to navigate ongoing patent disputes with other entities over SUNOSI. The company aims to submit the settlement for review by federal regulators.
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AXSM May 13, 2025AXSMGeneral
Axsome Therapeutics Enters $570 Million Term Loan and Revolving Credit Facility with Blackstone Previous term loan facility retired
Axsome Therapeutics has entered into a $570 million term loan and revolving credit facility with Blackstone, retiring its previous loan with Hercules Capital. This arrangement is expected to improve financial terms, enhance operational agility, and significantly reduce interest expenses. The deal involves a $500 million term loan and a $70 million revolving credit facility, with opportunities to access additional funds. Axsome aims to leverage this financing to accelerate its path to profitability and shareholder value enhancement while continuing its mission to support patients with CNS disorders.
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AXSM May 5, 2025AXSMGeneral
Axsome Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update Total 1Q 2025 net product revenue of $121.5 million, representing 62% year-over-year growth AUVELITY 1Q 2025 net product sales
Axsome Therapeutics reported a strong financial performance for Q1 2025, with total net product revenue reaching $121.5 million, a growth of 62% year-over-year. Key highlights include the successful approval of SYMBRAVO for migraine treatment and substantial sales growth for AUVELITY. The company also noted the submission of several NDAs for various indications, including fibromyalgia and Alzheimer's disease agitation. Despite a reported net loss, Axsome remains optimistic about its future pipeline, which addresses multiple serious CNS conditions.
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AXSM May 1, 2025AXSMGeneral
Axsome Therapeutics and Mental Health America (MHA) Join Voices to Highlight Mental Health Month
Axsome Therapeutics has partnered with Mental Health America to highlight Mental Health Month in May 2025. The initiative aims to raise awareness about mental health issues, particularly the ongoing mental health crisis affecting many individuals in the U.S. As part of their efforts, Axsome's headquarters in New York will be lit green to symbolize mental health awareness. The collaboration will provide resources for individuals and communities to advocate for mental health support and improvement.
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AXSM Apr 8, 2025AXSMGeneral
Axsome Therapeutics to Report First Quarter 2025 Financial Results on May 5
Axsome Therapeutics, a biopharmaceutical company focused on CNS disorders, will report its financial results for the first quarter of 2025 on May 5, 2025. The announcement includes a conference call at 8:00 a.m. Eastern Time to discuss the results and provide further business insights. Investors can participate in the call via phone or through a live webcast, with a replay available for 30 days post-event. The company has issued forward-looking statements regarding future performance and potential risks associated with the commercial success of its products.
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AXSM Apr 4, 2025AXSMPhases
▼ -8.4%on this newsshared move
Axsome Therapeutics Presents Positive Pivotal Phase 3 Results of the ACCORD-2 Trial of AXS-05 in Alzheimer s Disease Agitation and the SYMPHONY Trial of AXS-12 in Narcolepsy at the
Axsome Therapeutics Presents Positive Pivotal Phase 3 Results of the ACCORD-2 Trial of AXS-05 in Alzheimer s Disease Agitation and the SYMPHONY Trial of AXS-12 in Narcolepsy at the
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AXSM Apr 1, 2025AXSMPhases
Axsome Therapeutics Announces Topline Results of PARADIGM Phase 3 Proof-of-Concept Trial of Solriamfetol in Major Depressive Disorder (MDD) with and without Excessive Daytime Sleepiness (EDS) Results support continued de
Axsome Therapeutics announced the topline results of the PARADIGM Phase 3 trial for solriamfetol in major depressive disorder (MDD) with and without excessive daytime sleepiness (EDS). While the overall patient population did not exhibit a significant change in depressive symptoms compared to placebo, a prespecified subgroup of patients with severe EDS showed greater improvements. The company's results support the continuation of research in this area, with plans for a Phase 3 trial in MDD patients with EDS starting in 2025. Solriamfetol was found to be safe and well tolerated.
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AXSM Mar 25, 2025AXSMPhases
▼ -6.8%on this news
Axsome Therapeutics Announces FOCUS Phase 3 Trial of Solriamfetol in Adults with Attention Deficit Hyperactivity Disorder (ADHD) Achieves Primary Endpoint Demonstrated substantial and statistically significant improvemen
Axsome Therapeutics announced that the FOCUS Phase 3 trial of solriamfetol successfully met its primary and key secondary endpoints in adults with ADHD. The trial demonstrated significant reductions in ADHD symptoms and overall disease severity compared to placebo. With results showing a mean reduction of nearly 50% in ADHD symptoms, solriamfetol is poised to be a new treatment option for adults. The safety profile was favorable and consistent with prior studies, and plans for future trials in pediatric patients are anticipated.
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AXSM Mar 5, 2025AXSMGeneral
Axsome Therapeutics Settles Sunosi (solriamfetol) Patent Litigation with Hikma Pharmaceuticals
Axsome Therapeutics has entered into a settlement agreement with Hikma Pharmaceuticals, resolving ongoing patent litigation concerning its product Sunosi (solriamfetol). The settlement allows Hikma to sell a generic version of Sunosi starting in March 2040, subject to FDA approval and pediatric exclusivity conditions. This agreement aims to clarify market entry while similar litigation involving other parties continues. Axsome's focus remains on advancing its portfolio for central nervous system disorders.
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AXSM Mar 3, 2025AXSMFDA Updates
Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-05 in Alzheimer's Disease Agitation Supporting NDA Submission Supplemental New Drug Application (sNDA) submission anticipated in 3Q 2025
Axsome Therapeutics announced that the FDA has provided pre-NDA meeting minutes supporting their upcoming supplemental NDA for AXS-05 intended for treating Alzheimer's disease agitation. The company plans to submit this application in the third quarter of 2025, with the product having previously received Breakthrough Therapy designation. Clinical trials have shown promising results, indicating that AXS-05 significantly alleviates agitation symptoms in Alzheimer's patients. The FDA's feedback suggests that the requisite regulatory data is sufficient for the submission process.
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AXSM Feb 24, 2025AXSMPhases
▼ -5.1%on this newsshared move
Axsome Therapeutics Announces SYMBRAVO (meloxicam and rizatriptan) Achieves Primary Endpoint in the EMERGE Phase 3 Trial in Migraine Patients Experiencing Inadequate Response to Oral CGRP Inhibitors
Axsome Therapeutics announced that SYMBRAVO (meloxicam and rizatriptan) successfully met its primary endpoint in the EMERGE Phase 3 trial for migraine patients who had inadequate responses to oral CGRP inhibitors. The trial showed statistically significant improvements in pain response, with 47.9% of patients achieving pain freedom within two hours, compared to only 1.0% with oral CGRPs. Moreover, SYMBRAVO was associated with higher rates of sustained pain relief and enhanced quality of life. The favorable safety profile and the innovative multi-mechanistic approach of SYMBRAVO offer promising potential for effective migraine treatment.
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AXSM Feb 18, 2025AXSMGeneral
Axsome Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update Total 4Q and full year 2024 net product revenue of $118.8 million and $385.7 million, respectively, representin
Axsome Therapeutics reported strong financial results for Q4 and the full year of 2024, with total net product revenue reaching $118.8 million and $385.7 million, reflecting year-over-year growth of 66% and 88% respectively. The company highlighted the growth of its flagship product, Auvelity, which experienced a 89% increase in sales. Additionally, Axsome announced the U.S. approval of Symbravo for migraine treatment and successful Phase 3 trial completions for AXS-05 in Alzheimer's agitation and AXS-12 in narcolepsy, paving the way for potential NDA submissions in 2025. However, the firm faced a net loss of $74.9 million in Q4 2024, which, while improved from the previous year, raises concerns about rising costs in R&D and SG&A.
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AXSM Feb 10, 2025AXSMGeneral
▲ +20.2%on this news
Axsome Therapeutics Announces Settlement Agreement Resolving AUVELITY (dextromethorphan HBr – bupropion HCl) Patent Litigation
Axsome Therapeutics announced a settlement with Teva Pharmaceuticals, resolving all patent litigation related to its product AUVELITY. This agreement allows Teva to market a generic version of AUVELITY under specific conditions after 2038 or 2039. The resolution is seen as supportive of Axsome's innovative approach to treating central nervous system disorders and reflects the strength of its intellectual property. The settlement has been submitted for review by the U.S. Federal Trade Commission and the Department of Justice.
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AXSM Jan 31, 2025AXSMConferences/Events
Axsome Therapeutics Hosts SYMBRAVO FDA Approval Virtual Investor Event with Expert Thought Leader
Axsome Therapeutics will host a virtual investor event to discuss the FDA approval of SYMBRAVO, a novel treatment for acute migraine. The event will feature Dr. Stewart Tepper sharing insights on the migraine treatment landscape. SYMBRAVO is designed to provide fast, consistent relief but carries serious risks such as heart attack and gastrointestinal complications, emphasizing the need for careful patient selection in its use.
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AXSM Jan 30, 2025AXSMFDA Updates
Axsome Therapeutics Announces FDA Approval of SYMBRAVO (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults A single oral dose of SYMBRAVO provided rapid migraine pain freedom an
Axsome Therapeutics has received FDA approval for SYMBRAVO, a novel treatment for acute migraine in adults, utilizing a combination of meloxicam and rizatriptan. Clinical trials showed that SYMBRAVO can offer rapid pain relief within two hours and sustained efficacy for up to 48 hours for many patients. Approximately 85% of study participants did not require rescue medication within 24 hours, highlighting its effectiveness across various pain severities. The medication incorporates Axsome's rapid absorption technology and is expected to be available commercially in the U.S. in about four months.
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AXSM Jan 22, 2025AXSMConferences/Events
▲ +6.3%on this news
Axsome Therapeutics to Report Fourth Quarter and Full Year 2024 Financial Results on February 18
Axsome Therapeutics announced it will report its financial results for the fourth quarter and full year of 2024 on February 18, 2025. The company will host a conference call at 8:00 a.m. ET to discuss these results and provide a business update. Axsome is focused on innovations in CNS disorder treatments, highlighting its commitment to improving patient outcomes with its existing FDA-approved products and development programs.
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AXSM Jan 13, 2025AXSMGeneral
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Axsome Therapeutics Provides Preliminary Fourth Quarter and Full Year 2024 Net Revenue Auvelity preliminary 4Q and full year 2024 net product sales of $92.6 million and $291.4 million, respectively Sunosi preliminary 4Q
Axsome Therapeutics announced its preliminary net product revenues for the fourth quarter and full year 2024, reporting projected sales of $92.6 million for Auvelity and $25.7 million for Sunosi in Q4. Overall, the company anticipates total product revenues of approximately $118.3 million in Q4 and $385.2 million for the year. The CEO highlighted the success of their neuroscience pipeline, including positive Phase 3 results for AXS-05 and AXS-12, while also preparing for potential product launches in 2025. However, the preliminary data is subject to adjustments after financial procedures are completed.
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AXSM Dec 30, 2024AXSMPhases
Axsome Therapeutics Announces Successful Completion and Results of Phase 3 Clinical Program of AXS-05 in Alzheimer's Disease Agitation ACCORD-2 Phase 3 trial in Alzheimer's disease agitation achieves primary endpoint com
Axsome Therapeutics announced the successful completion of its Phase 3 clinical program for AXS-05 in managing Alzheimer's disease agitation. The ACCORD-2 trial achieved its primary endpoint with statistically significant results, showing a delay in relapse time compared to placebo. AXS-05 was found to be safe and well-tolerated across trials, with additional plans to submit an NDA to the FDA by the second half of 2025. Although the ADVANCE-2 trial showed numerically favorable results, it did not achieve statistical significance for primary endpoints.
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AXSM Nov 26, 2024AXSMPhases
Axsome Therapeutics Announces AXS-12 Achieves Primary Endpoint in ENCORE Long-Term Phase 3 Trial in Narcolepsy AXS-12 statistically significantly reduced the frequency of cataplexy attacks compared to placebo (p=0.017, p
Axsome Therapeutics announced that its drug AXS-12 achieved the primary endpoint in the ENCORE Phase 3 trial for narcolepsy, showing significant reductions in cataplexy attacks compared to placebo. The trial also indicated improvements in cognition, excessive daytime sleepiness, and overall narcolepsy symptoms among treated patients. AXS-12 was well tolerated with no new safety signals detected, supporting its potential as an important treatment option. Axsome plans to pursue an NDA filing with the FDA to advance AXS-12 towards market approval.
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AXSM Nov 12, 2024AXSMGeneral
▲ +9.4%on this news
Axsome Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update Total 3Q 2024 net product revenue of $104.8 million, representing 81% year-over-year growth Auvelity 3Q 2024 net product sales
Axsome Therapeutics reported strong financial results for Q3 2024, with total net product revenue of $104.8 million, reflecting an 81% year-over-year increase. Notably, Auvelity's sales surged by 113% year-over-year, contributing $80.4 million. The company is expanding its sales force in response to growing demand and has a critical NDA resubmission for AXS-07 due on January 31, 2025. Additionally, pivotal Phase 3 trial results for several product candidates are anticipated by early 2025, suggesting a robust pipeline for the company's future.
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AXSM Nov 8, 2024AXSMPhases
Axsome Therapeutics Presents Data from Its Leading Neuroscience Pipeline at NEI Congress 2024
Axsome Therapeutics Presents Data from Its Leading Neuroscience Pipeline at NEI Congress 2024
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AXSM Oct 29, 2024AXSMConferences/Events
Axsome Therapeutics Presents Data from Multiple Programs Spanning Its Innovative Neuroscience Portfolio at Psych Congress 2024
Axsome Therapeutics, a biopharmaceutical company focused on treating central nervous system disorders, has announced seven presentations at Psych Congress 2024. The presentations cover various clinical trials including AXS-05 for Major Depressive Disorder and treatments for Alzheimer's Disease-related agitation. These presentations aim to highlight innovative approaches and real-world treatment effects, showcasing the company's commitment to addressing conditions with limited treatment options. The event takes place in Boston from October 29 to November 2, 2024.
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AXSM Oct 15, 2024AXSMGeneral
Axsome Therapeutics to Report Third Quarter 2024 Financial Results on November 12
Axsome Therapeutics, Inc. is set to report its third quarter financial results for 2024 on November 12, 2024. The report will be available before the U.S. financial markets open, followed by a conference call at 8:00 a.m. ET. During the call, management will discuss the financial outcomes as well as provide an update on the business. As a biopharmaceutical company, Axsome is focused on developing novel therapies for central nervous system (CNS) disorders.
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AXSM Sep 24, 2024AXSMConferences/Events
Axsome Therapeutics Presents Data from Multiple Programs at Sleep Europe 2024
Axsome Therapeutics, Inc. announced the presentation of seven studies related to AXS-12 and solriamfetol at Sleep Europe 2024 in Seville, Spain. The studies include results from the SYMPHONY Phase 3 trial on AXS-12 for narcolepsy and insights from a patient survey regarding type 1 narcolepsy. Additionally, prior research on solriamfetol indicates improvements in cognitive function for patients experiencing excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea.
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AXSM Sep 4, 2024AXSMFDA Updates
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Axsome Therapeutics Announces FDA Acceptance of NDA Resubmission for AXS-07 for the Acute Treatment of Migraine FDA sets PDUFA action goal date of
Axsome Therapeutics has announced that the FDA has accepted the resubmission of their NDA for AXS-07, a novel treatment for acute migraine. The resubmission was designated as a Class 2, and the FDA has set a PDUFA action goal date of January 31, 2025. This treatment combines meloxicam and rizatriptan, aiming to provide expedited relief from migraine symptoms. Currently, AXS-07 is not FDA approved and is backed by over 200 patents, ensuring market protection until 2038.
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AXSM Aug 27, 2024AXSMConferences/Events
Axsome Therapeutics to Participate in Investor Conferences in September
Axsome Therapeutics is set to participate in four key investor conferences throughout September 2024, including events hosted by Morgan Stanley and Wells Fargo in New York and Boston. The company will present its latest developments in therapies for central nervous system disorders. Live webcasts from the conferences will be available on the company's website, ensuring wider access to their presentations. This engagement signals Axsome's commitment to enhancing investor relations and promoting its innovative CNS treatments.
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AXSM Aug 21, 2024AXSMGeneral
Axsome Therapeutics Reaches Agreement to Dismiss Sunosi (Solriamfetol) Patent Litigation with Sandoz Inc.
Axsome Therapeutics has reached an agreement with Sandoz Inc. to dismiss the ongoing patent litigation concerning Sunosi (solriamfetol). This litigation arose after Sandoz filed an Abbreviated New Drug Application to market a generic version of Sunosi. With the withdrawal of Sandoz's ANDA, the litigation was dismissed without prejudice, providing Axsome an opportunity to preserve its market position for Sunosi.
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AXSM Aug 11, 2024AXSMFDA Updates
AXSOME ALERT: Bragar Eagel & Squire, P.C. is Investigating Axsome Therapeutics, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm
Bragar Eagel & Squire, P.C. is investigating Axsome Therapeutics, Inc. on behalf of long-term stockholders due to a class action complaint involving possible breaches of fiduciary duties by the board. Concerns arose from misleading statements related to their investigational migraine medication, AXS-07, particularly regarding unresolved chemistry, manufacturing, and control (CMC) issues that may affect its New Drug Application (NDA) review. The company's ability to meet regulatory timelines is now in question, as indicated by significant stock price declines following negative disclosures from the FDA and public announcements.
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AXSM Aug 5, 2024AXSMGeneral
Axsome Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update Total 2Q 2024 net product revenue of $87.2 million, representing 87% year-over-year growth Auvelity 2Q 2024 net product sales
Axsome Therapeutics reported strong financial results for the second quarter of 2024, with net product revenue of $87.2 million, reflecting 87% growth year-over-year. Notable sales included $65 million from Auvelity, which showed a remarkable 135% increase. The company is actively advancing its pipeline, with upcoming Phase 3 trial results expected in the second half of the year. However, the report also detailed a net loss of $79.3 million and rising operational expenses, indicating ongoing financial challenges.
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AXSM Jul 11, 2024AXSMConferences/Events
Axsome Therapeutics to Report Second Quarter 2024 Financial Results on August 5
Axsome Therapeutics, Inc. has announced that it will report its financial results for the second quarter of 2024 on August 5, 2024, before U.S. financial markets open. The company's management will hold a conference call at 8:00 a.m. Eastern Time on the same day to discuss these results and provide a business update. Interested parties can participate via a toll-free number or through a live webcast on the company’s website. A recording of the call will also be available for 30 days post-event.
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AXSM Jun 5, 2024AXSMGeneral
Axsome Therapeutics Settles Sunosi (solriamfetol) Patent Litigation with Unichem Laboratories
Axsome Therapeutics has announced a settlement with Unichem Laboratories regarding patent litigation over its product Sunosi (solriamfetol). The settlement permits Unichem to sell a generic version of Sunosi starting June 30, 2042, with possibilities for earlier entry under certain conditions. The agreement is pending review by the U.S. Federal Trade Commission and Department of Justice. A parallel litigation involving Axsome and other parties remains unresolved in the New Jersey court.
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AXSM Jun 4, 2024AXSMGeneral
Axsome Therapeutics Joins the American Migraine Foundation to Highlight Unmet Treatment Needs During Migraine & Headache Awareness Month
Axsome Therapeutics has partnered with the American Migraine Foundation to raise awareness about the unmet treatment needs of migraine sufferers during Migraine & Headache Awareness Month. The company aims to educate the public on the complexities of migraines, which not only cause significant pain but also have a substantial economic impact. With over 37 million Americans affected, Axsome seeks to promote effective management and treatment options for migraine patients.
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AXSM Jun 3, 2024AXSMGeneral
Axsome Therapeutics Supports Alzheimer’s & Brain Awareness Month
Axsome Therapeutics, a biopharmaceutical company, announced its support for Alzheimer's & Brain Awareness Month in June 2024. The initiative aims to enhance awareness of Alzheimer's disease and its impact on patients and caregivers. As part of this observance, their headquarters will be illuminated in purple on June 21, 2024. The company emphasizes the importance of mental health and the challenges posed by Alzheimer's, which is expected to affect nearly 14 million individuals in the U.S. by 2060.
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AXSM May 29, 2024AXSMConferences/Events
Axsome Therapeutics Highlights Data on Solriamfetol Demonstrating Improvement in Cognitive Function in Patients with Obstructive Sleep Apnea or Narcolepsy at SLEEP 2024
Axsome Therapeutics announced five presentations on solriamfetol at the upcoming SLEEP 2024 conference, showcasing its benefits for cognitive function in patients with obstructive sleep apnea (OSA) and narcolepsy. Notably, the SHARP study highlighted solriamfetol's improvements in executive function, memory, and processing speed, emphasizing cognitive functioning's importance in sleep disorders. This presentation aligns with Axsome's commitment to developing novel therapies for central nervous system conditions.
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AXSM May 28, 2024AXSMConferences/Events
Axsome Therapeutics Presents Data from Multiple Programs at the 2024 American Society of Clinical Psychopharmacology Annual (ASCP) Meeting
Axsome Therapeutics is set to present data from its innovative CNS disorder programs at the ASCP Annual Meeting in May 2024. Key presentations include new findings regarding Auvelity's effects on major depressive disorder (MDD) symptoms, highlighting improvements in daily functioning. Additional data will cover the clinical profile of AXS-05 in treating agitation in Alzheimer’s disease. These presentations underscore Axsome's leadership in developing therapies for complex brain disorders.
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AXSM May 8, 2024AXSMConferences/Events
Axsome Therapeutics to Present at Upcoming Investor Conferences
Axsome Therapeutics will have its Chief Executive Officer, Herriot Tabuteau, participate in two upcoming investor conferences: the RBC Capital Markets 2024 Global Healthcare Conference on May 14 and the Bank of America 2024 Healthcare Conference on May 16. Both events will feature fireside chats aimed at discussing the company's advancements and strategies within the biopharmaceutical sector focused on CNS disorders. This is part of Axsome's ongoing efforts to engage with the investment community and share their developments in therapeutic options.
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AXSM May 6, 2024AXSMGeneral
Axsome Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update Total 1Q 2024 net product revenue of $75.0 million, representing 160% year-over-year growth Auvelity 1Q 2024 net product sales
Axsome Therapeutics reported strong financial results for Q1 2024, achieving $75.0 million in net product revenue, a 160% increase year-over-year. Key drugs, Auvelity and Sunosi, also reported significant sales growth, with Auvelity sales up by 240%. The company announced positive Phase 3 trial results for AXS-12 in narcolepsy and initiated several other pivotal trials. Despite these positive developments, Axsome posted a net loss of $68.4 million, highlighting the challenges of increasing R&D and operational costs.
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AXSM May 1, 2024AXSMGeneral
Axsome Therapeutics Recognizes May as Mental Health Awareness Month
Axsome Therapeutics has announced its involvement in Mental Health Awareness Month, joining efforts with Mental Health America to highlight the significance of mental health. The company is providing educational resources and support for individuals facing mental health challenges. As part of the awareness campaign, Axsome will illuminate its headquarters in green to symbolize mental health awareness. The initiative underscores the importance of mental health as a fundamental aspect of overall well-being.
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AXSM Apr 15, 2024AXSMConferences/Events
Axsome Therapeutics Highlights Innovative Neuroscience Portfolio at the American Academy of Neurology (AAN) 2024 Annual Meeting
Axsome Therapeutics showcased its innovative neuroscience portfolio during the American Academy of Neurology (AAN) 2024 Annual Meeting, held in Denver, Colorado. Key presentations included findings on AXS-05's efficacy in treating agitation associated with Alzheimer’s disease and new data from the AXS-07 migraine clinical trials. Additionally, advancements in solriamfetol for cognitive enhancement and sleep disorders were shared. The focus on these therapies underscores Axsome's commitment to developing novel treatments for central nervous system conditions.
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AXSM Apr 10, 2024AXSMGeneral
Axsome Therapeutics to Report First Quarter 2024 Financial Results on May 6
Axsome Therapeutics, Inc. has announced that it will report its financial results for the first quarter of 2024 on May 6, prior to the opening of U.S. financial markets. The company plans to hold a conference call at 8:00 a.m. ET on the same day to discuss the results and provide a business update. As a firm dedicated to developing innovative therapies for CNS disorders, Axsome is focused on transforming treatment approaches in this area.
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AXSM Apr 1, 2024AXSMPhases
Axsome Therapeutics Initiates ENGAGE Phase 3 Trial of Solriamfetol for the Treatment of Binge Eating Disorder
Axsome Therapeutics has announced the initiation of the ENGAGE Phase 3 trial to evaluate solriamfetol as a treatment for binge eating disorder in adults. This randomized, double-blind, placebo-controlled study will enroll about 450 patients over a 12-week period, assessing the efficacy and safety of the drug. Binge eating disorder, which affects approximately 7 million U.S. adults, is a serious condition marked by recurrent episodes of excessive eating and a sense of lack of control.
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AXSM Mar 25, 2024AXSMGeneral
Axsome Therapeutics Announces Results of CRESCENDO Narcolepsy Patient Survey Demonstrating Unmet Needs in Treated Narcolepsy Type 1 Patients 77% of narcolepsy type 1 patients continue to experience cataplexy attacks desp
Axsome Therapeutics published results from the CRESCENDO survey, highlighting significant unmet needs in treatment for narcolepsy type 1 patients. The survey, conducted with 203 patients, revealed that a majority continue to suffer from symptoms such as cataplexy and excessive daytime sleepiness despite being treated. Furthermore, cognitive impairment and high rates of depression and anxiety were prevalent among participants. This research underscores the challenges faced by patients and aims to raise awareness of narcolepsy's impact on their lives.
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AXSM Mar 25, 2024AXSMPhases
Axsome Therapeutics Announces AXS-12 Achieves Primary Endpoint in the SYMPHONY Phase 3 Trial in Narcolepsy AXS-12 statistically significantly reduced cataplexy attacks compared to placebo (p=0.018, primary endpoint) AXS-
Axsome Therapeutics announced that its drug AXS-12 achieved the primary endpoint in the SYMPHONY Phase 3 trial for narcolepsy, demonstrating a statistically significant reduction in cataplexy attacks compared to placebo. The results also showed improved symptoms related to excessive daytime sleepiness, cognitive function, and overall quality of life for patients. The trial included 90 participants over a five-week period, confirming AXS-12's potential as a meaningful treatment option for narcolepsy. Axsome plans to present these results at scientific meetings and continue to promote further development of AXS-12.
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AXSM Mar 19, 2024AXSMPhases
▲ +6%on this news
Axsome Therapeutics Initiates PARADIGM Phase 3 Trial of Solriamfetol for the Treatment of Major Depressive Disorder
Axsome Therapeutics has announced the initiation of the PARADIGM Phase 3 trial for solriamfetol, an investigational treatment for major depressive disorder (MDD). The trial involves around 300 adult patients and will assess the safety and efficacy of solriamfetol compared to a placebo over a duration of six weeks. MDD is a significant mental health challenge with many patients not responding adequately to current therapies, highlighting the need for new treatment options.
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AXSM Mar 5, 2024AXSMConferences/Events
Axsome Therapeutics to Present at the Leerink Partners Global Biopharma Conference
Axsome Therapeutics, Inc. announced that its CEO, Herriot Tabuteau, will take part in a fireside chat at the upcoming Leerink Partners Global Biopharma Conference. This event, scheduled for March 13, 2024, will spotlight the company's innovative therapies aimed at central nervous system disorders. Attendees can access a live webcast of the discussion, highlighting the company's commitment to improving treatment options. The company remains aware of the various risks and uncertainties associated with clinical trials and regulatory approvals.
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AXSM Feb 27, 2024AXSMConferences/Events
Axsome Therapeutics to Present at the TD Cowen 44th Annual Healthcare Conference
Axsome Therapeutics, Inc. announced that its CEO, Herriot Tabuteau, will participate in a fireside chat at the TD Cowen 44th Annual Healthcare Conference scheduled for March 6, 2024. The event aims to highlight Axsome's developments in central nervous system therapies. Additionally, attendees will have access to a live webcast of the session. Axsome continues to work on transforming treatment options for CNS disorders in response to limited current choices.
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AXSM Feb 20, 2024AXSMGeneral
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Corporate Presentation February 2024 Certain information contained in this presentation may include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. W
Axsome Therapeutics has released a corporate presentation outlining its strategic focus on expanding its neuroscience portfolio. The company emphasizes the potential of its marketed products, Sunosi and Auvelity, along with several late-stage product candidates. However, it acknowledges risks associated with commercial success, ongoing clinical trials, and regulatory approvals from the FDA. The presentation highlights the large target patient population and the company's ambition to secure additional indications for its products.
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AXSM Feb 20, 2024AXSMGeneral
▼ -12.6%on this news
Axsome Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update Total 4Q and full year 2023 net product revenue of $71.5 million and $204.9 million, respectively, representing
Axsome Therapeutics reported substantial financial growth for 2023, with net product revenues reaching $204.9 million, up 309% year-over-year. The company's products, Auvelity and Sunosi, showed strong market performance, combined with forecasts for further advancements in their product pipeline, including NDA submissions for AXS-14 and AXS-07 in 2024. Despite these positive developments, the company incurred a net loss of $98.7 million in Q4 2023, largely due to increased R&D and commercialization expenses. Overall, Axsome anticipates continued growth and expansion through its ongoing clinical trials and product launches.
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AXSM Jan 23, 2024AXSMConferences/Events
Axsome Therapeutics to Report Fourth Quarter and Full Year 2023 Financial Results on February 20
Axsome Therapeutics announced that it will report its financial results for the fourth quarter and full year of 2023 on February 20, 2024. A conference call will take place on the same day at 8:00 a.m. Eastern Time, where management will discuss these financial results and provide a business update. The call will be accessible via a toll-free number and a live webcast on the company's website.
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AXSM Jan 8, 2024AXSMGeneral
▲ +8.1%on this news
Corporate Presentation January 2024 Certain information contained in this presentation may include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We
Axsome Therapeutics provided a corporate presentation outlining its current product portfolio and future pipeline, emphasizing its two marketed products, Sunosi and Auvelity. The presentation included forward-looking statements related to potential future results, including the anticipated success of ongoing clinical trials. However, it also highlighted risks associated with regulatory approvals and the ongoing funding needs for trial execution. The company targets significant patient populations with multiple therapeutic indications planned for future marketing.
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AXSM Jan 4, 2024AXSMFDA Updates
▲ +7.8%on this news· ran to +19% by day 3shared move
Axsome Therapeutics Provides Preliminary Fourth Quarter and Full Year 2023 Net Revenue and 2024 Anticipated Milestones Preliminary total 4Q and full year 2023 net product revenue of $71 million and $204 million, respecti
Axsome Therapeutics provided preliminary financial results for the fourth quarter and full year 2023, reporting net product revenues of $71 million and $204 million, respectively. The company anticipates key regulatory milestones in 2024, including NDA submissions for AXS-14 in fibromyalgia and AXS-07 for migraine, along with multiple clinical trial readouts. Axsome has successfully treated around 100,000 unique patients with its products, Auvelity and Sunosi. The company is optimistic about its pipeline prospects, which includes several clinical trial initiations for various CNS disorders.
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AXSM Dec 11, 2023AXSMConferences/Events
Axsome Therapeutics Presents New Data and Post Hoc Analyses of Auvelity in Patients with Major Depressive Disorder at the American College of Neuropsychopharmacology ACNP 2023 Annu
Axsome Therapeutics Presents New Data and Post Hoc Analyses of Auvelity in Patients with Major Depressive Disorder at the American College of Neuropsychopharmacology ACNP 2023 Annu
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AXSM Dec 7, 2023AXSMConferences/Events
Axsome Therapeutics Hosts Solriamfetol Virtual Investor Event with Expert Thought Leaders Today
Axsome Therapeutics is hosting a virtual investor event today to discuss solriamfetol, a dual-acting dopamine and norepinephrine reuptake inhibitor. The event will feature insights from leading physicians on various indications of the drug, including major depressive disorder and attention deficit hyperactivity disorder. The Axsome senior leadership team will also outline clinical development plans for solriamfetol. This event underscores Axsome's commitment to advancing treatment options for central nervous system disorders.
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AXSM Nov 28, 2023AXSMGeneral
Axsome Therapeutics, Inc. investors: Please contact the Portnoy Law Firm to recover your losses; December 7, 2023 deadline.
Axsome Therapeutics is facing a lawsuit by investors alleging false and misleading statements regarding the company's operations, particularly concerning AXS-07. Significant Chemistry, Manufacturing, and Controls issues hindered the development of AXS-07, leading to questions about the company's ability to meet FDA approval timelines. Following the revelations, Axsome's stock price declined sharply. The Portnoy Law Firm is seeking to assist affected investors in recovering their losses related to the alleged corporate misconduct.
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AXSM Nov 22, 2023AXSMConferences/Events
Axsome Therapeutics to Host Solriamfetol Virtual Investor Event on December 7
Axsome Therapeutics announced a virtual investor event scheduled for December 7, 2023, to provide updates on its solriamfetol development programs. The company will present insights from physician thought leaders on current and potential future indications for solriamfetol. Additionally, the senior leadership team will outline the clinical development plans for this dual-acting dual-acting dopamine and norepinephrine reuptake inhibitor. Investors can access the event through a live webcast, with a replay available for 30 days after.
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AXSM Nov 21, 2023AXSMConferences/Events
Axsome Therapeutics to Present at the Piper Sandler 35th Annual Healthcare Conference
Axsome Therapeutics, Inc. will be presenting at the Piper Sandler 35th Annual Healthcare Conference on November 28, 2023. CEO Herriot Tabuteau will partake in a fireside chat, highlighting the company's focus on central nervous system disorders. The event aims to inform investors about the company's ongoing efforts in developing novel therapies. A live webcast of the presentation will also be accessible to the public through the company's website.
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AXSM Nov 6, 2023AXSMGeneral
Axsome Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update Total 3Q 2023 product revenue of $57.8 million, representing 244% year-over-year growth Auvelity 3Q 2023 net product sales of
Axsome Therapeutics reported robust financial results for Q3 2023, with total product revenue of $57.8 million, a 244% increase from the previous year. The company's growth is driven by Auvelity, which saw net sales of $37.7 million, and Sunosi, which earned $20.1 million in net revenue. Following positive performance, Axsome is preparing to advance multiple clinical trials and NDA submissions in 2024. However, the company also reported a large net loss, highlighting the increasing costs associated with its growth strategy.
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AXSM Nov 2, 2023AXSMGeneral
Axsome Therapeutics and the Global Alzheimer’s Disease Community Come Together in Raising Support for the Millions Affected by This Illness During Alzheimer’s Disease Awareness Month 2023
Axsome Therapeutics is participating in Alzheimer’s Disease Awareness Month 2023 by joining advocacy organizations worldwide to raise awareness for Alzheimer’s disease. As part of this initiative, their headquarters in New York City will be illuminated in teal to symbolize support for those affected by this illness. Alzheimer's, which currently afflicts an estimated 6 million individuals in the U.S., is recognized for its significant emotional and financial impacts on affected individuals and their families. This campaign aims to highlight the pressing need for innovative research and treatment options for Alzheimer’s disease.
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AXSM Oct 24, 2023AXSMPhases
Axsome Therapeutics Presents Results of the ACCORD trial of AXS-05 in Alzheimer’s Disease Agitation at the Clinical Trials on Alzheimer’s Disease (CTAD) 2023 Conference
Axsome Therapeutics presented positive results from the ACCORD Phase 3 trial of AXS-05, a treatment for agitation associated with Alzheimer's disease, at the CTAD 2023 Conference. The study showed AXS-05 significantly delayed the relapse of agitation symptoms compared to placebo and was well-tolerated by patients. Agitation is a common issue in Alzheimer's patients, affecting their quality of life and leading to increased caregiver burden. AXS-05's results highlight its potential as a new therapeutic option in addressing this severe symptom of Alzheimer's disease.
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AXSM Oct 11, 2023AXSMGeneral
Axsome Therapeutics Appoints Dr. Sue Mahony to its Board of Directors
Axsome Therapeutics has appointed Dr. Sue Mahony to its Board of Directors, effective immediately. Dr. Mahony has significant experience in drug development and commercialization, having held senior leadership positions at major pharmaceutical companies such as Eli Lilly and Horizon Therapeutics. She is expected to enhance Axsome's board expertise while helping to drive the company's growth in the central nervous system (CNS) treatment area. Her background and commitment to patient care align with Axsome's goals of providing innovative therapies for CNS disorders.
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AXSM Oct 10, 2023AXSMConferences/Events
Axsome Therapeutics to Report Third Quarter 2023 Financial Results on November 6
Axsome Therapeutics, Inc. will announce its financial results for the third quarter of 2023 on November 6, which will be followed by a conference call to discuss the outcomes. The company specializes in developing therapies for central nervous system (CNS) disorders. Axsome is committed to improving patient care through innovation. The upcoming results may impact investor sentiment and the company's future strategy.
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AXSM Oct 2, 2023AXSMGeneral
Axsome Therapeutics Joins the National Alliance on Mental Illness and Others Advocating for the Importance of Mental Health on Mental Illness Awareness Week
Axsome Therapeutics, Inc. has announced its collaboration with various patient advocacy organizations, including the National Alliance on Mental Illness (NAMI), to promote Mental Illness Awareness Week (MIAW) running from October 1-7, 2023. The company aims to raise awareness about mental health and support initiatives that benefit individuals affected by CNS disorders. This includes sponsoring NAMI's upcoming event, 'Inspiring Hope Through Research,' which will recognize advancements in mental health treatment. The initiative reflects Axsome's commitment to improving resources and treatments in the mental health sector.
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AXSM Sep 21, 2023AXSMConferences/Events
Axsome Therapeutics Joins the Global Narcolepsy Community in Raising Awareness on World Narcolepsy Day
Axsome Therapeutics is collaborating with over 20 global patient advocacy organizations to raise awareness of narcolepsy for World Narcolepsy Day on September 22, 2023. They are sponsoring events including a virtual panel discussion and attending the Narcolepsy Network's annual conference. The efforts underline Axsome's commitment to support patients with narcolepsy and improve treatment access through advocacy and collaboration. The company focuses on developing innovative therapies for CNS disorders, aimed at enhancing patients' lives.
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AXSM Sep 7, 2023AXSMConferences/Events
Axsome Therapeutics Highlights Commitment to Innovating Treatments for Mental Health Conditions with Presentations at Psych Congress 2023
Axsome Therapeutics presented data at the U.S. Psych Congress 2023, showcasing the efficacy and safety of its CNS disorder treatments, AUVELITY and SUNOSI. Highlights included data on improving patient functioning in major depressive disorder and excessive daytime sleepiness. Five research posters were finalists for the Psych Congress Poster Awards, reflecting significant recognition in the field. Despite potential benefits, the presentations also noted serious risks associated with these treatments, including side effects such as seizures and hypertension.
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AXSM Sep 5, 2023AXSMConferences/Events
Axsome Therapeutics to Present at Three Upcoming Investor Conferences
Axsome Therapeutics, Inc. announced that its CEO, Herriot Tabuteau, will participate in three investor conferences in September 2023. The events include the H.C. Wainwright 25th Annual Global Investment Conference, Morgan Stanley 21st Annual Global Healthcare Conference, and TD Cowen 3rd Annual Novel Mechanisms in Neuropsychiatry Summit. These presentations will provide insights into the company's developments and initiatives in managing central nervous system disorders.
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AXSM Aug 15, 2023AXSMGeneral
Corporate Presentation August 2023 Certain information contained in this presentation may include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We
Axsome Therapeutics presented a corporate update in August 2023, detailing both their current marketed products and a pipeline of development candidates. The presentation highlighted the company's focus on CNS disorders and outlined the risks inherent in their forward-looking statements, particularly regarding clinical trials and FDA approvals. Axsome aims to address large unmet medical needs but faces challenges including funding, regulatory hurdles, and market acceptance of their products. The success of their initiatives remains uncertain and dependent on future developments.
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AXSM Aug 7, 2023AXSMGeneral
Axsome Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update Total 2Q 2023 product revenue of $46.7 million Auvelity 2Q 2023 net product sales of $27.6 million, representing 76% quarter-
Axsome Therapeutics reported robust financial results for Q2 2023, with total product revenue reaching $46.7 million, largely driven by a significant increase in Auvelity sales. The company also announced plans to initiate Phase 3 trials for new indications of solriamfetol. Despite the positive developments, Axsome experienced a net loss of $67.2 million, which was higher than the previous year. Overall, the financial performance indicates a strong market presence but highlights increasing expenses related to R&D and commercialization efforts.
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AXSM Jul 12, 2023AXSMGeneral
Axsome Therapeutics to Report Second Quarter 2023 Financial Results on August 7
Axsome Therapeutics, Inc. announced it will release its financial results for the second quarter of 2023 on August 7, 2023. This update will be made available before the U.S. financial markets open, followed by a conference call at 8:00 a.m. Eastern Time to discuss the results and provide further business updates. The company emphasizes its commitment to developing novel therapies for CNS disorders with limited treatment options.
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AXSM Jul 7, 2023AXSMPhases
Axsome Therapeutics Initiates FOCUS Phase 3 Trial of Solriamfetol for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults
Axsome Therapeutics announced the initiation of the FOCUS Phase 3 trial for solriamfetol, targeting adult ADHD treatment. This multicenter trial will involve around 450 participants, assessing the drug's efficacy through a randomized, double-blind, placebo-controlled design. The primary endpoint is based on the Adult ADHD Investigator Symptom Report Scale. Despite being a promising candidate, solriamfetol is currently not FDA-approved for this indication, raising uncertainties about trial outcomes.
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AXSM Jun 30, 2023AXSMGeneral
Axsome Therapeutics Announces Closing of Public Offering of $225 Million of Shares of Common Stock
Axsome Therapeutics has successfully closed a public offering of 3,000,000 shares of common stock, generating $225 million in gross proceeds. The company plans to allocate these funds towards advancing its late-stage pipeline, supporting existing and potential new clinical programs, and enhancing commercialization efforts. The offering was managed by SVB Securities, along with several joint bookrunning managers. While this offering bolsters Axsome's financial position, there remain uncertainties related to clinical trial outcomes and regulatory approvals that could influence future success.
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AXSM Jun 28, 2023AXSMGeneral
▼ -10.1%on this newsshared move
Axsome Therapeutics Announces Pricing of Public Offering of $225 Million of Shares of Common Stock
Axsome Therapeutics announced the pricing of a public offering for 3,000,000 shares of common stock, priced at $75.00 per share, totaling $225 million. The company intends to use the proceeds to support its late-stage pipeline, including clinical programs and commercialization efforts. The offering is set to close around June 30, 2023, pending customary closing conditions, and includes an option for underwriters to purchase additional shares.
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AXSM Jun 27, 2023AXSMGeneral
Axsome Therapeutics Announces Proposed Public Offering of Common Stock
Axsome Therapeutics has announced a proposed public offering of its common stock to fund its late-stage pipeline and expansion of commercialization efforts. The offering will also provide underwriters with the option to purchase an additional 15% of the shares sold. The company aims to use the proceeds for ongoing clinical programs and general corporate purposes. The announcement comes with inherent risks, including market volatility and the uncertain success of clinical trials.
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AXSM Jun 1, 2023AXSMConferences/Events
Axsome Therapeutics to Present New Sunosi Data at SLEEP 2023
Axsome Therapeutics announced that it will present new data on Sunosi at the upcoming SLEEP 2023 meeting. The presentations will focus on the SHARP study, which demonstrated significant cognitive improvements in patients with excessive daytime sleepiness associated with obstructive sleep apnea. Results show sustained cognitive enhancement over an 8-hour period with once daily dosing. Additionally, data from the SURWEY study will provide real-world insights into Sunosi's usage among patients in Germany.
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AXSM May 30, 2023AXSMConferences/Events
Axsome Therapeutics to Present Data and Post Hoc Analyses on Auvelity and Sunosi at the 2023 American Society of Clinical Psychopharmacology ASCP Annual Meeting
Axsome Therapeutics to Present Data and Post Hoc Analyses on Auvelity and Sunosi at the 2023 American Society of Clinical Psychopharmacology ASCP Annual Meeting
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AXSM May 8, 2023AXSMGeneral
▲ +5.4%on this news
Axsome Therapeutics Reports First Quarter 2023 Financial Results and Corporate Update Auvelity 1Q 2023 net product sales of $15.7 million Total 1Q 2023 net product sales of $28.6 million Total 1Q 2023 revenue of $94.6 mi
Axsome Therapeutics reported strong financial results for Q1 2023, with total revenues of $94.6 million, including significant sales from its products Auvelity and Sunosi. Auvelity generated $15.7 million in net sales, marking its first full quarter of launch, while Sunosi sales amounted to $12.9 million. The company also noted significant investments in R&D and sales, contributing to an $11.2 million net loss. Despite the loss, Axsome is optimistic about its pipeline and operational outlook aiming for cash flow positivity.
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AXSM May 3, 2023AXSMConferences/Events
Axsome Therapeutics to Present at the Bank of America Securities 2023 Healthcare Conference
NEW YORK, May 03, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Execu
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AXSM May 1, 2023AXSMGeneral
Axsome Therapeutics Joins Mental Health America and the State of New York to Raise Awareness of Mental Health During May is Mental Health Month
NEW YORK, May 01, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, is joining Mental Health America (MHA) and the State of New Yor
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AXSM Apr 21, 2023AXSMPhases
Axsome Therapeutics to Present Five Abstracts Including New Data from the Positive SHARP Study of SUNOSI (solriamfetol) in Participants with Cognitive Impairment with Excessive Daytime Sleepiness in Obstructive Sleep Apnea at the 2023 American Academy of Neurology (AAN) Annual Meeting
NEW YORK, April 21, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that it will be presenting five abstracts at
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AXSM Apr 14, 2023AXSMConferences/Events
▲ +5.3%on this news
Axsome Therapeutics to Present at the 22nd Annual Needham Virtual Healthcare Conference
NEW YORK, April 14, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Exe
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AXSM Apr 13, 2023AXSMGeneral
Axsome Therapeutics to Report First Quarter 2023 Financial Results on May 8
NEW YORK, April 13, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that it will report its financial results for
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AXSM Mar 1, 2023AXSMConferences/Events
Axsome Therapeutics to Present at Cowen’s 43rd Annual Health Care Conference
NEW YORK, March 01, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Exe
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AXSM Feb 27, 2023AXSMGeneral
Axsome Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update Total fourth quarter net product sales of $24.4 million Auvelity launched October 19th, with fourth quarter net
Axsome Therapeutics reported its financial results for the fourth quarter and full year of 2022, achieving net product sales of $24.4 million, primarily driven by the launch of Auvelity. The company noted strong early adoption metrics for this newly launched product, alongside significant sales performance for Sunosi. Despite the positive sales and strategic partnerships, Axsome also reported a net loss of $61.2 million for the fourth quarter, a rise from the previous year's figures. The company's financial outlook remains optimistic with an expected cash balance of over $300 million, which supports ongoing commercialization and clinical development efforts.
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AXSM Feb 22, 2023AXSMGeneral
Axsome Therapeutics Enters into License Agreement with Pharmanovia to Expand Commercialization and Further Develop Sunosi (solriamfetol) in Europe Axsome to receive an upfront payment of $66 million, and is eligible to r
Axsome Therapeutics has entered into a license agreement with Pharmanovia to commercialize and further develop its drug Sunosi in Europe and MENA. Axsome will receive an upfront payment of $66 million and may earn additional milestones totaling up to $101 million. Pharmanovia will handle marketing, clinical, and regulatory responsibilities and plans to initiate a pivotal Phase 3 study for Sunosi in pediatric patients. This collaboration aims to improve accessibility to Sunosi, which addresses excessive daytime sleepiness due to narcolepsy and obstructive sleep apnea.
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AXSM Feb 7, 2023AXSMConferences/Events
Axsome Therapeutics to Present at the SVB Securities Global Biopharma Conference
NEW YORK, Feb. 07, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Exec
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AXSM Jan 31, 2023AXSMGeneral
Axsome Therapeutics to Report Fourth Quarter and Full Year 2022 Financial Results on February 27
NEW YORK, Jan. 31, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that it will report its financial results for
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AXSM Dec 7, 2022AXSMPhases
Axsome Therapeutics Presents New Data from the EVOLVE Open Label Trial Demonstrating Effects of AUVELITY on Cognitive and Physical Functioning in Patients with Major Depressive Dis
Axsome Therapeutics Presents New Data from the EVOLVE Open Label Trial Demonstrating Effects of AUVELITY on Cognitive and Physical Functioning in Patients with Major Depressive Dis
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AXSM Nov 28, 2022AXSMPhases
▲ +31.5%on this news
Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in the ACCORD Phase 3 Trial in Alzheimer's Disease Agitation AXS-05 statistically significantly delayed time to relapse of Alzheimer's disease agitation vers
Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in the ACCORD Phase 3 Trial in Alzheimer's Disease Agitation
AXS-05 statistically significantly delayed time to relapse of Alzheimer's disease agitation versus placebo (p=0.014, primary endpoint)
AXS-05 statisticall
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AXSM Nov 23, 2022AXSMConferences/Events
Axsome Therapeutics to Present at the 5th Annual Evercore ISI HealthCONx Conference
NEW YORK, Nov. 23, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Exec
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AXSM Nov 9, 2022AXSMConferences/Events
▼ -7%on this news
Axsome Therapeutics to Present at the Guggenheim 4th Annual Immunology and Neurology Conference
NEW YORK, Nov. 09, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Exec
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AXSM Nov 7, 2022AXSMPhases
Axsome Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update Sunosi third quarter U.S. net sales of $16.8 million Auvelity launched and available in U.S. pharmacies SHARP study results an
Axsome Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update
Sunosi third quarter U.S. net sales of $16.8 million
Auvelity launched and available in U.S. pharmacies
SHARP study results announced demonstrating statistically significant improveme
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AXSM Oct 21, 2022AXSMGeneral
▼ -6.2%on this news
Axsome Therapeutics to Report Third Quarter 2022 Financial Results on November 7, 2022
Axsome to host conference call and webcast on Monday, November 7, 2022 at 8:00 AM Eastern Time
NEW YORK, Oct. 21, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of centra
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AXSM Oct 20, 2022AXSMGeneral
Axsome Therapeutics Announces Availability of AUVELITY , the First and Only Oral NMDA Receptor Antagonist for the Treatment of Major Depressive Disorder in Adults AUVELITY is the first and only rapid-acting oral treatmen
Axsome Therapeutics Announces Availability of AUVELITY , the First and Only Oral NMDA Receptor Antagonist for the Treatment of Major Depressive Disorder in Adults
AUVELITY is the first and only rapid-acting oral treatment approved with labeling of statistically significant impro
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AXSM Oct 10, 2022AXSMGeneral
Axsome Therapeutics Voices its Commitment to Mental Health on World Mental Health Day 2022
NEW YORK, Oct. 10, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, is joining the World Health Organization’s (WHO) 2022 World Me
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AXSM Oct 3, 2022AXSMPhases
Axsome Therapeutics Announces Sunosi (Solriamfetol) Meets Primary Endpoint Demonstrating Improvement in Cognitive Function in the SHARP Trial in Cognitively Impaired Patients with Excessive Daytime Sleepiness Associated
Axsome Therapeutics Announces Sunosi (Solriamfetol) Meets Primary Endpoint Demonstrating Improvement in Cognitive Function in the SHARP Trial in Cognitively Impaired Patients with Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea
Statistically significant impr
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AXSM Sep 29, 2022AXSMFDA Updates
▼ -5.4%on this newsshared move
Axsome Therapeutics Announces Plans to Resubmit AXS-07 NDA Based on Successful FDA Type A Meeting
Axsome Therapeutics Announces Plans to Resubmit AXS-07 NDA Based on Successful FDA Type A Meeting
NEW YORK, September 29, 2022 (GLOBE NEWSWIRE) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of c
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AXSM Sep 21, 2022AXSMConferences/Events
▼ -7.9%on this news· ran to -22% by day 3
Axsome Therapeutics to Present at the Ladenburg Thalmann Healthcare Conference
NEW YORK, Sept. 21, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Exe
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AXSM Sep 14, 2022AXSMConferences/Events
Axsome Therapeutics to Present at the Cowen 2nd Annual Novel Mechanisms in Neuropsychiatry Summit
NEW YORK, Sept. 14, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Exe
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AXSM Sep 8, 2022AXSMPhases
Axsome Therapeutics Initiates ADVANCE-2 Phase 3 Trial of AXS-05 in Alzheimer's Disease Agitation
Axsome Therapeutics Initiates ADVANCE-2 Phase 3 Trial of AXS-05 in Alzheimer's Disease Agitation
NEW YORK, Sept. 08, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of cen
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AXSM Sep 7, 2022AXSMGeneral
Axsome Therapeutics Announces Publication of Post-hoc Analysis of Sunosi Effect on Excessive Daytime Sleepiness in Narcolepsy or Obstructive Sleep Apnea Patients with a History of Depression in the Journal of Psychiatric Research
NEW YORK, Sept. 07, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the publication of a post-hoc analysis compar
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AXSM Sep 6, 2022AXSMConferences/Events
Axsome Therapeutics to Present at the Morgan Stanley 20th Annual Global Healthcare Conference
NEW YORK, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Exe
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AXSM Sep 1, 2022AXSMPhases
Axsome Therapeutics Initiates EMERGE Phase 3 Open-Label Trial of AXS-07 for the Acute Treatment of Migraine in Adults with a Prior Inadequate Response to an Oral CGRP Inhibitor
Axsome Therapeutics Initiates EMERGE Phase 3 Open-Label Trial of AXS-07 for the Acute Treatment of Migraine in Adults with a Prior Inadequate Response to an Oral CGRP Inhibitor
NEW YORK, September 1, 2022 (GLOBE NEWSWIRE) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceut
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AXSM Aug 19, 2022AXSMFDA Updates
▲ +40.3%on this news· ran to +56% by day 3
Axsome Therapeutics Announces FDA Approval of
Axsome Therapeutics Announces FDA Approval of
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AXSM Aug 19, 2022AXSMFDA Updates
▲ +40.3%on this news· ran to +56% by day 3
Axsome Therapeutics Announces FDA Approval of AUVELITY TM , the First and Only Oral NMDA Receptor Antagonist for the Treatment of Major Depressive Disorder in Adults AUVELITY is the first and only rapid-acting oral treat
Axsome Therapeutics Announces FDA Approval of
AUVELITYTM, the First and Only Oral NMDA Receptor Antagonist for the Treatment of Major Depressive Disorder in Adults
AUVELITY is the first and only rapid-acting oral treatment approved with labeling of statistically significant imp
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AXSM Aug 9, 2022AXSMConferences/Events
Axsome Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update Company to host conference call today at 8:00 AM Eastern
Axsome Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update
Company to host conference call today at 8:00 AM Eastern
NEW YORK, August 9, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing
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AXSM Jul 28, 2022AXSMGeneral
Axsome Therapeutics to Report Second Quarter 2022 Financial Results on August 9, 2022
Axsome to host conference call and webcast on Tuesday, August 9, 2022 at 8:00 AM Eastern Time
NEW YORK, July 28, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central
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AXSM Jul 8, 2022AXSMGeneral
Axsome Therapeutics, Inc. Investors: Filing date July 12, 2022; Contact the Portnoy Law Firm to Recover Losses
Investors can contact the law firm at no cost to learn more about recovering their losses
LOS ANGELES, July 08, 2022 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Axsome Therapeutics, Inc. (“Axsome” or the “Company”) (NASDAQ: AXSM) investors that a class action filed on behal
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AXSM Jul 6, 2022AXSMGeneral
AXSOME THERAPEUTICS, INC. (NASDAQ: AXSM) SHAREHOLDER CLASS ACTION ALERT: Bernstein Liebhard LLP Reminds Investors of the Deadline to File a Lead Plaintiff Motion in a Securities Class Action Lawsuit Against Axsome Therapeutics, Inc. (NASDAQ: AXSM)
Did you lose money on investments in Axsome Therapeutics? If so, please visit Axsome Therapeutics, Inc. Shareholder Class Action Lawsuit or contact Peter Allocco at (212) 951-2030 or pallocco@bernlieb.com to discuss your rights.
NEW YORK, July 06, 2022 (GLOBE NEWSWIRE) -- Bernst
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AXSM Jun 28, 2022AXSMGeneral
Axsome Therapeutics Hosts Sunosi Investor Update Virtual Event Today with Key Opinion Leaders
NEW YORK, June 28, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, is hosting a virtual event today at 9:00 AM EDT to provide inv
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AXSM Jun 28, 2022AXSMGeneral
Sunosi (solriamfetol) Investor Update
Sunosi (solriamfetol) Investor Update June 28, 2022
Forward Looking Statements & Safe Harbor Certain matters discussed in this presentation are forward-looking statements . We may, in some cases, use terms such as predicts, believes, potential, continue, estimates, anticipates,
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AXSM Jun 22, 2022AXSMGeneral
Axsome Therapeutics to Host Sunosi Investor Update Virtual Event
NEW YORK, June 22, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that it will host a virtual event on Tuesday,
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AXSM Jun 13, 2022AXSMGeneral
▼ -8.9%on this newsshared move
Axsome Therapeutics, Inc. Investors: Contact the Portnoy Law Firm to Recover Losses
Investors can contact the law firm at no cost to learn more about recovering their losses
LOS ANGELES, June 13, 2022 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Axsome Therapeutics, Inc. (“Axsome” or the “Company”) (NASDAQ: AXSM) investors that a class action filed on behal
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AXSM Jun 6, 2022AXSMConferences/Events
Axsome Therapeutics Announces Results of the SUPPORT Survey of Patients with Major Depressive Disorder Presented at the American Society of Clinical Psychopharmacology Association (ASCP) 2022 Annual Meeting
Survey conducted in collaboration with the Depression and Bipolar Support Alliance (DBSA)
Survey respondents reported persistence of high levels of depressive symptoms and interference with work and daily functioning despite treatment
Respondents reported low levels of hope and
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AXSM Jun 2, 2022AXSMPhases
Axsome Therapeutics Presents New Data from the GEMINI Trial Demonstrating Efficacy of AXS-05 on Anhedonia in Patients with Major Depressive Disorder AXS-05 rapidly and significantly improved anhedonic symptoms, measured
Axsome Therapeutics Presents New Data from the GEMINI Trial Demonstrating Efficacy of AXS-05 on Anhedonia in Patients with Major Depressive Disorder
AXS-05 rapidly and significantly improved anhedonic symptoms, measured by the MADRS anhedonia subscale, starting 1 week after trea
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AXSM Jun 1, 2022AXSMConferences/Events
Axsome Therapeutics Announces Late-Breaking Presentations of Positive Results of the EVOLVE Trial of AXS-05 in Major Depressive Disorder After Prior Treatment Failures at the American Society of Clinical Psychopharmacolo
Axsome Therapeutics Announces Late-Breaking Presentations of Positive Results of the EVOLVE Trial of AXS-05 in Major Depressive Disorder After Prior Treatment Failures at the American Society of Clinical Psychopharmacology (ASCP) 2022 Annual Meeting
Rapid, substantial, and durab
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AXSM May 31, 2022AXSMPhases
▼ -5.5%on this newsshared move
Axsome Therapeutics Announces Publication of Pivotal GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder in The Journal of Clinical Psychiatry AXS-05 (dextromethorphan-bupropion) demonstrated rapid, substantial,
Axsome Therapeutics Announces Publication of Pivotal GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder in The Journal of Clinical Psychiatry
AXS-05 (dextromethorphan-bupropion) demonstrated rapid, substantial, and statistically significant antidepressant efficacy compa
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AXSM May 18, 2022AXSMPhases
▼ -7.3%on this news
Axsome Therapeutics Announces Publication of Pivotal ASCEND Phase 2 Trial of AXS-05 in Major Depressive Disorder in The American Journal of Psychiatry In this study, AXS-05 (dextromethorphan-bupropion) demonstrated rapid
Axsome Therapeutics Announces Publication of Pivotal ASCEND Phase 2 Trial of AXS-05 in Major Depressive Disorder in The American Journal of Psychiatry
In this study, AXS-05 (dextromethorphan-bupropion) demonstrated rapid, substantial, and statistically significant antidepressant
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AXSM May 18, 2022AXSMGeneral
▼ -7.3%on this news
AXSOME THERAPEUTICS, INC. CLASS ACTION ALERT: Wolf Haldenstein Adler Freeman & Herz LLP announces that a securities class action lawsuit has been filed in the United States District Court for the Southern District of New York against Axsome Therapeutics, Inc.
NEW YORK, May 18, 2022 (GLOBE NEWSWIRE) -- Wolf Haldenstein Adler Freeman & Herz LLP announces that a federal securities class action lawsuit has been filed in the United States District Court for the Southern District of New York behalf of persons and entities that purchased or
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AXSM May 9, 2022AXSMGeneral
▼ -10.1%on this news
Axsome Therapeutics Completes U.S. Acquisition of Sunosi (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea Axsome is committed to providing patients uninterrupted acces
Axsome Therapeutics Completes U.S. Acquisition of
Sunosi (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
Axsome is committed to providing patients uninterrupted access to Sunosi and advancing research for patients living wit
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AXSM May 9, 2022AXSMGeneral
▼ -10.1%on this news
Axsome Therapeutics Completes U.S. Acquisition of
Axsome Therapeutics Completes U.S. Acquisition of
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AXSM May 2, 2022AXSMConferences/Events
▲ +7.2%on this news
Axsome Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update Company to host conference call today at 8:00 AM Eastern
Axsome Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update
Company to host conference call today at 8:00 AM Eastern
NEW YORK, May 2, 2022 /PRNewswire/ Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel thera
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AXSM Apr 28, 2022AXSMGeneral
AXSOME ALERT: Bragar Eagel & Squire, P.C. is Investigating Axsome Therapeutics, Inc. on Behalf of Axsome Stockholders and Encourages Investors to Contact the Firm
NEW YORK, April 27, 2022 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, is investigating potential claims against Axsome Therapeutics, Inc. (“Axsome” or the “Company”) (NASDAQ: AXSM) on behalf of Axsome stockholders. Our inve
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AXSM Apr 25, 2022AXSMGeneral
▼ -22%on this newsshared move
Axsome Therapeutics, Inc. Investors: Company Investigated by the Portnoy Law Firm
Investors can contact the law firm at no cost to learn more about recovering their losses
LOS ANGELES, April 25, 2022 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Axsome Therapeutics, Inc. (“Axsome” or the “Company”) (NASDAQ: AXSM) investors that the firm has initiated an in
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AXSM Mar 28, 2022AXSMFDA Updates
Axsome Therapeutics to Acquire Sunosi from Jazz Pharmaceuticals, Expanding Axsome's Leadership in Neuroscience Sunosi is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) approved by th
Axsome Therapeutics to Acquire Sunosi from Jazz Pharmaceuticals, Expanding Axsome's Leadership in Neuroscience
Sunosi is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) approved by the FDA to improve wakefulness in adults living with excessiv
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AXSM Mar 25, 2022AXSMGeneral
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACT
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
ASSET PURCHASE AGREEMENT
Jazz Pharmaceuticals plc,
a
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AXSM Mar 11, 2022AXSMConferences/Events
Axsome Therapeutics to Participate in the 1st Annual Needham Virtual Neuroscience Forum
NEW YORK, March 11, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer,
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AXSM Mar 2, 2022AXSMConferences/Events
Axsome Therapeutics to Present at the Cowen 42nd Annual Health Care Conference
NEW YORK, March 02, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer,
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AXSM Mar 1, 2022AXSMConferences/Events
▲ +10.2%on this newsshared move
Axsome Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update Company to host conference call today at 8:00 AM Eastern
Axsome Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update
Company to host conference call today at 8:00 AM Eastern
NEW YORK, March 01, 2022 (GLOBE NEWSWIRE) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company
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AXSM Feb 15, 2022AXSMGeneral
▲ +8.2%on this news
Axsome Therapeutics to Report Fourth Quarter and Full Year 2021 Financial Results on March 1 2022
Axsome Therapeutics to Report Fourth Quarter and Full Year 2021 Financial Results on March 1 2022
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AXSM Feb 11, 2022AXSMConferences/Events
Axsome Therapeutics to Present at the 11th Annual SVB Leerink Global Healthcare Conference
NEW YORK, Feb. 11, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer,
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AXSM Nov 8, 2021AXSMConferences/Events
▲ +7.9%on this news
Axsome Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Update Company to host conference call today at 8:00 AM Eastern
Axsome Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Update
Company to host conference call today at 8:00 AM Eastern
NEW YORK, November 8, 2021 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing no
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AXSM Oct 20, 2021AXSMGeneral
Axsome Therapeutics to Report Third Quarter 2021 Financial Results on November 8, 2021
Axsome to host conference call and webcast on Monday, November 8, 2021 at 8:00 AM Eastern Time
NEW YORK, Oct. 20, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous syste
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AXSM Oct 18, 2021AXSMFDA Updates
Axsome Therapeutics Expands Term Loan Facility with Hercules Capital to $300 Million $100 million now available upon the potential FDA approval of AXS-05
Axsome Therapeutics Expands Term Loan Facility with Hercules Capital to $300 Million
$100 million now available upon the potential FDA approval of AXS-05
NEW YORK, October 18, 2021 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing
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AXSM Sep 16, 2021AXSMPhases
Axsome Therapeutics Initiates SYMPHONY Phase 3 Trial of AXS-12 in Narcolepsy
Axsome Therapeutics Initiates SYMPHONY Phase 3 Trial of AXS-12 in
NEW YORK, September 16, 2021 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company
developing novel therapies for the management of central nervous system (CNS) disorders, enrolle
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AXSM Sep 14, 2021AXSMFDA Updates
Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-07 for the Acute Treatment of Migraine
Axsome Therapeutics Announces FDA Acceptance of New Drug Application for
AXS-07 for the Acute Treatment of Migraine
NEW YORK, September 14, 2021 (Globe Newswire)
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management
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AXSM Aug 23, 2021AXSMGeneral
▲ +15%on this news
Axsome Therapeutics Provides Update on the New Drug Application for AXS-05 for the Treatment of Major Depressive Disorder
Axsome Therapeutics Provides Update on the New Drug Application for AXS-05 for the Treatment of Major Depressive Disorder
NEW YORK, August 23, 2021 (Globe Newswire) - Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the managem
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AXSM Aug 9, 2021AXSMPhases
▼ -46.5%on this news
Axsome Therapeutics Announces AXS-05 Achieves Primary and Key Secondary Endpoints in the MERIT Phase 2 Trial in Treatment Resistant Depression
AXS-05 significantly delayed the time to relapse of depression compared to placebo (p=0.002, primary endpoint)
AXS-05 significantly prevented relapse of depression over at least 6 months compared to placebo (p=0.004, key secondary endpoint)
NEW YORK, Aug. 09, 2021 (GLOBE NEWSWI
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AXSM Aug 9, 2021AXSMGeneral
▼ -46.5%on this news
AXSOME THERAPEUTICS INVESTIGATION: Block & Leviton Investigates Axsome Therapeutics For Potential Securities Law Violations; Investors Who Have Lost Money Are Encouraged to Contact the Firm
BOSTON, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Block & Leviton is investigating Axsome Therapeutics, Inc. (NASDAQ: AXSM) for potential securities law violations. Investors who have lost money in their Axsome Therapeutics investment should contact the firm to learn more about how they
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AXSM Aug 9, 2021AXSMConferences/Events
▼ -46.5%on this news
Axsome Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Update Company to host conference call today at 8:00 AM Eastern
Axsome Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Update
Company to host conference call today at 8:00 AM Eastern
NEW YORK, August 9, 2021 (Globe Newswire) - Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing n
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AXSM Jul 15, 2021AXSMGeneral
Axsome Therapeutics to Report Second Quarter 2021 Financial Results on August 9, 2021
Axsome to host conference call and webcast on Monday, August 9, 2021 at 8:00 AM Eastern Time
NEW YORK, July 15, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system
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AXSM Jun 15, 2021AXSMFDA Updates
Axsome Therapeutics Announces Planned NDA Submission for AXS-14 for the Management of Fibromyalgia Submission anticipated in 4Q 2022
Axsome Therapeutics Announces Planned NDA Submission for AXS-14 for the Management of Fibromyalgia
Submission anticipated in 4Q 2022
NEW YORK, June 15, 2021 (Globe Newswire) - Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for t
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AXSM May 10, 2021AXSMConferences/Events
Axsome Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update Company to host conference call today at 8:00 AM Eastern
Axsome Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update
Company to host conference call today at 8:00 AM Eastern
NEW YORK, May 10, 2021 (Globe Newswire) - Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing nove
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AXSM May 7, 2021AXSMGeneral
Axsome Therapeutics Joins Mental Health America and other Advocacy Organizations in Raising Awareness and Providing Support for Mental Health During Mental Health Month
NEW YORK, May 07, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM) is joining Mental Health America (MHA) and other advocacy organizations in observing May is Mental Health Month, by raising awareness of and supporting people living with depression, anxiety, and
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AXSM Apr 27, 2021AXSMGeneral
Axsome Therapeutics to Report First Quarter 2021 Financial Results on May 10, 2021
Axsome to host conference call and webcast on Monday, May 10, 2021 at 8:00 AM Eastern Time
NEW YORK, April 27, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (
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AXSM Apr 26, 2021AXSMFDA Updates
Axsome Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for AXS-05 for Treatment of Major Depressive Disorder FDA grants Priority Review and sets PDUFA action goal date of
Axsome Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for AXS-05 for Treatment of Major Depressive Disorder
FDA grants Priority Review and sets PDUFA action goal date of August 22, 2021
NEW YORK, April 26, 2021 (Globe Newswire) - Axsome Therap
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AXSM Mar 1, 2021AXSMConferences/Events
Axsome Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update Company to host conference call today at 8:00 AM Eastern
Axsome Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
Company to host conference call today at 8:00 AM Eastern
NEW YORK, March 1, 2021 (Globe Newswire) - Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company
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AXSM Feb 24, 2021AXSMConferences/Events
Certain information contained in this presentation may include "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts,"
Corporate Presentation
SVB Leerink Global Healthcare Conference
February 24, 2021 Axsome Therapeutics, Inc. Exhibit 99.1
Certain information contained in this presentation may include "forward-looking statements" within the meaning of the Private Securities Litigation Reform A
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AXSM Feb 16, 2021AXSMGeneral
Axsome Therapeutics to Report Fourth Quarter and Full Year 2020 Financial Results on March 1, 2021
Axsome to host conference call and webcast on Monday, March 1, 2021 at 8:00 AM Eastern Time
NEW YORK, Feb. 16, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (
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AXSM Dec 31, 2020AXSMPhases
Axsome Therapeutics Initiates ACCORD Phase 3 Trial of AXS-05 in Alzheimer’s Disease Agitation
ACCORD is the second pivotal trial of AXS-05 in Alzheimer’s disease agitation
No treatments are currently approved for Alzheimer’s disease agitation
NEW YORK, Dec. 31, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing nove
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AXSM Dec 31, 2020AXSMPhases
Axsome Therapeutics Announces Positive Efficacy and Safety Results from the Phase 3 MOVEMENT Long-Term Trial of AXS-07 in the Acute Treatment of Migraine Over 21,000 migraine attacks treated with AXS-07 Achieved migraine
Axsome Therapeutics Announces Positive Efficacy and Safety Results from the Phase 3 MOVEMENT Long-Term Trial of AXS-07 in the Acute Treatment of Migraine
Over 21,000 migraine attacks treated with AXS-07
Achieved migraine pain relief in approximately 70% of patients, and pain fr
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AXSM Dec 8, 2020AXSMGeneral
Axsome Therapeutics Announces Positive Results from the COMET-SI Trial of AXS-05 in Patients with Major Depressive Disorder Who Have Suicidal Ideation 68% reduction in MADRS Suicidality Item score by Week 1, and 82% redu
Axsome Therapeutics Announces Positive Results from the COMET-SI Trial of AXS-05 in Patients with Major Depressive Disorder Who Have Suicidal Ideation
68% reduction in MADRS Suicidality Item score by Week 1, and 82% reduction by Week 4
Resolution of suicidal ideation achieved b
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AXSM Dec 2, 2020AXSMGeneral
Axsome Therapeutics Announces Positive Results from the COMET-TRD Trial of AXS-05 in Patients with Treatment Resistant Depression Rapid and substantial improvement in depressive symptoms achieved by 44% of patients at 2
Axsome Therapeutics Announces Positive Results from the COMET-TRD Trial of AXS-05 in Patients with Treatment Resistant Depression
Rapid and substantial improvement in depressive symptoms achieved by 44% of patients at 2 weeks, 67% at 6 weeks (MADRS response), and sustained with
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AXSM Dec 1, 2020AXSMPhases
Axsome Therapeutics Announces Positive Efficacy and Safety Results from Phase 3 COMET Long-Term Trial and COMET-AU Trial of AXS-05 in Major Depressive Disorder Rapid and substantial improvement in depressive symptoms ach
Axsome Therapeutics Announces Positive Efficacy and Safety Results from Phase 3 COMET Long-Term Trial and COMET-AU Trial of AXS-05 in Major Depressive Disorder
Rapid and substantial improvement in depressive symptoms achieved by 40% of patients at 2 weeks, 73% at 6 weeks (MADRS
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AXSM Nov 5, 2020AXSMPhases
Axsome Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update COMET Phase 3 long-term safety trial of AXS-05 in MDD, and MOVEMENT Phase 3 long-term safety trial of AXS-07 in migraine compl
Axsome Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update
COMET Phase 3 long-term safety trial of AXS-05 in MDD, and MOVEMENT Phase 3 long-term safety trial of AXS-07 in migraine completed
NDA submissions for AXS-05 in depression expected in
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AXSM Nov 4, 2020AXSMGeneral
Axsome Therapeutics and Veeva Systems Partner to Build Axsome’s Digital-Centric Commercialization™ Platform
Collaboration provides Axsome access to new digital technologies developed by Veeva
NEW YORK and PLEASANTON, Calif., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central n
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AXSM Nov 3, 2020AXSMPhases
Axsome Therapeutics to Present Data from the ADVANCE-1 Trial of AXS-05 in Alzheimer’s Disease Agitation at the 13th Clinical Trials on Alzheimer’s Disease (CTAD) Conference
NEW YORK, Nov. 03, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it will present data from the ADVANCE-1 trial of AXS-05
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AXSM Oct 28, 2020AXSMGeneral
Axsome Therapeutics to Report Third Quarter 2020 Financial Results on November 5, 2020
Axsome to host conference call and webcast on Thursday, November 5, 2020 at 8:00 AM Eastern Time
NEW YORK, Oct. 28, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous sys
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AXSM Sep 29, 2020AXSMGeneral
Axsome Therapeutics Announces $225 Million Term Loan Facility with Hercules Capital Non-dilutive committed capital extends cash runway into at least 2024 Facility strengthens balance sheet through anticipated commercial
Axsome Therapeutics Announces $225 Million Term Loan Facility with Hercules Capital
Non-dilutive committed capital extends cash runway into at least 2024
Facility strengthens balance sheet through anticipated commercial launches of Axsome's two lead CNS product candidates
NEW
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AXSM Sep 24, 2020AXSMPhases
Axsome Therapeutics Presents New Data from MOMENTUM Phase 3 Trial with AXS-07 Demonstrating Rapid Onset of Action and Reduced Symptom Recurrence in the Acute Treatment of Migraine Significantly faster time to pain relief
Axsome Therapeutics Presents New Data from MOMENTUM Phase 3 Trial with AXS-07 Demonstrating Rapid Onset of Action and Reduced Symptom Recurrence in the Acute Treatment of Migraine
Significantly faster time to pain relief as compared to rizatriptan (p<0.001)
Significantly less r
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AXSM Sep 21, 2020AXSMFDA Updates
Axsome Therapeutics Announces Expedited Development of AXS-12 for the Treatment of Narcolepsy Based on FDA Breakthrough Therapy Meeting Single Phase 3 trial to be conducted to support an NDA filing of AXS-12 in the treat
Therapeutics Announces Expedited Development of AXS-12 for the Treatment of Narcolepsy Based on FDA Breakthrough Therapy Meeting
Single Phase 3 trial to
be conducted to support an NDA filing of AXS-12 in the treatment of narcolepsy; trial initiation anticipated 1Q 2021
patient
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AXSM Sep 17, 2020AXSMPhases
Axsome Therapeutics Announces AXS-07 Phase 3 Migraine Trial Results Selected by the American Academy of Neurology Science Committee as Featured Presentation
Data from MOMENTUM Phase 3 trial to be presented at the 2020 AAN Science Highlights Platform
NEW YORK, Sept. 17, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system
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AXSM Sep 16, 2020AXSMConferences/Events
NASDAQ: AXSM Corporate Presentation September 2020 © Axsome Therapeutics, Inc. Certain information contained in this presentation may include “forward-looking statements” within the meaning of the Priv
Corporate 37 Issued U.S. Patents 8 Issued O-U.S. Patents Claims extending to 2034 >45 pending Proprietary Manufacturing Drug Product Formulation 41 issued U.S. Patents 3 issued O-U.S. Patent Claims extending to 2036 >45 pending Proprietary Manufacturing Drug Product Formulation A
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AXSM Sep 14, 2020AXSMPhases
Axsome Therapeutics Presents New Data from GEMINI Phase 3 Trial with AXS-05 Demonstrating Rapid and Significant Improvements in Patient-Reported Outcomes in Major Depressive Disorder Rapid, durable, and statistically sig
Axsome Therapeutics Presents New Data
from GEMINI Phase 3 Trial with AXS-05 Demonstrating Rapid and Significant Improvements in Patient-Reported Outcomes in Major Depressive
Rapid, durable, and statistically significant
improvement demonstrated in patient-reported depressive s
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AXSM Sep 10, 2020AXSMConferences/Events
Axsome Therapeutics to Present New Data for AXS-05 in Major Depressive Disorder at the 33rd European College of Neuropsychopharmacology Congress
NEW YORK, Sept. 10, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it will present clinical data on AXS-05 in the treatmen
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AXSM Sep 8, 2020AXSMConferences/Events
Axsome Therapeutics to Present at the Morgan Stanley 18th Annual Global Healthcare Conference
NEW YORK, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer,
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AXSM Aug 31, 2020AXSMFDA Updates
Axsome Therapeutics Confirms Pivotal Status and Advancement of AXS-05 for the Treatment of Alzheimer’s Disease Agitation Based on Successful FDA Breakthrough Therapy Meeting
Previously completed positive, pivotal ADVANCE-1 trial sufficient with single additional Phase 3 efficacy trial for NDA in Alzheimer’s disease agitation
Initiation of Phase 3, placebo-controlled, randomized-withdrawal efficacy trial on track for 4Q 2020
Initiation of long-term
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AXSM Aug 28, 2020AXSMPhases
Axsome Therapeutics to Present Data from the CONCERT Phase 2 Trial of AXS-12 in Narcolepsy at the SLEEP 2020 Annual Meeting
NEW YORK, Aug. 28, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it will present efficacy and safety data from the CONCER
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AXSM Aug 20, 2020AXSMFDA Updates
Axsome Therapeutics Completes Successful FDA Pre-NDA Meeting for AXS-07 for the Acute Treatment of Migraine NDA submission on track for 4Q 2020
Axsome Therapeutics Completes Successful
FDA Pre-NDA Meeting for AXS-07 for the Acute Treatment of Migraine
NDA submission on track for 4Q 2020
NEW YORK, August 20, 2020 (Globe Newswire)
- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel
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AXSM Aug 10, 2020AXSMGeneral
Axsome Therapeutics Announces Further Progress in AXS-05 Depression Clinical Program
Enrollment complete in the COMET Phase 3 long-term safety trial of AXS-05 in MDD; NDA filing on track for 4Q 2020
Results from three Phase 2 open-label efficacy trials of AXS-05 in TRD, antidepressant unresponsive MDD, and suicidal ideation, expected in 4Q 2020
MERIT Phase 2 pl
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AXSM Aug 10, 2020AXSMFDA Updates
Axsome Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update Two NDA submissions, for AXS-05 in MDD and for AXS-07 in migraine, on track for 4Q 2020 Enrollment completed for both the AXS
Axsome Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update
Two NDA submissions, for AXS-05 in MDD and for AXS-07 in migraine, on track for 4Q 2020
Enrollment completed for both the AXS-05 Phase 3 long-term safety trial in MDD, and for the AXS
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AXSM Aug 5, 2020AXSMFDA Updates
Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-12 for the Treatment of Narcolepsy Designation offers potential for expedited development and review FDA Orphan Drug Designation previously grante
Axsome Therapeutics Receives FDA Breakthrough
Therapy Designation for AXS-12 for the Treatment of Narcolepsy
Designation offers potential for expedited
development and review
FDA Orphan Drug Designation previously
granted to Axsome for AXS-12 in narcolepsy
Third FDA Breakth
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AXSM Jul 30, 2020AXSMGeneral
Axsome Therapeutics to Report Second Quarter 2020 Financial Results on August 10, 2020
Axsome to host conference call and webcast on Monday, August 10, 2020 at 8:00 AM Eastern Time
NEW YORK, July 30, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system
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AXSM Jul 13, 2020AXSMFDA Updates
Axsome Therapeutics Completes Successful FDA Pre-NDA Meeting for AXS-05 for the Treatment of Major Depressive Disorder NDA submission on track for 4Q 2020
Axsome Therapeutics Completes Successful
FDA Pre-NDA Meeting for AXS-05 for the Treatment of Major
NDA submission on track for 4Q 2020
NEW YORK, July 13, 2020 (Globe Newswire)
- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies f
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AXSM Jun 26, 2020AXSMFDA Updates
Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-05 for the Treatment of Alzheimer's Disease Agitation Designation offers potential for expedited development and review Axsome now granted two Bre
Axsome Therapeutics Receives FDA Breakthrough
Therapy Designation for AXS-05 for the Treatment of Alzheimer's Disease Agitation
Designation offers potential for expedited
development and review
Axsome now granted two Breakthrough Therapy
designations for AXS-05 for separate
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AXSM May 29, 2020AXSMPhases
Axsome Therapeutics Presents Data from GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder at the 2020 American Society for Clinical Psychopharmacology Annual Meeting
NEW YORK, May 29, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that data from the GEMINI Phase 3 trial of AXS-05 in major dep
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AXSM May 26, 2020AXSMConferences/Events
Axsome Therapeutics to Host 2020 Annual Meeting of Stockholders Virtually
NEW YORK, May 26, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced the Company’s 2020 Annual Meeting of Stockholders will now be
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AXSM May 8, 2020AXSMPhases
Axsome Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update Clinical successes highlight Axsome's accelerated evolution into a leading CNS company Positive pivotal Phase 2/3 results for
Axsome Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update
Clinical successes highlight Axsome's accelerated evolution into a leading CNS company
Positive pivotal Phase 2/3 results for AXS-05 in Alzheimer's disease agitation further deepen inn
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AXSM Apr 30, 2020AXSMGeneral
Axsome Therapeutics to Report First Quarter 2020 Financial Results on May 8, 2020
Axsome to host conference call and webcast on Friday, May 8, 2020 at 8:00 AM Eastern Time
NEW YORK, April 30, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central ne
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AXSM Apr 27, 2020AXSMPhases
Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in the ADVANCE-1 Pivotal Phase 2/3 Trial in Alzheimer's Disease Agitation Statistically significant improvement in Alzheimer's disease agitation, as measured
Therapeutics Announces AXS-05 Achieves Primary Endpoint in the ADVANCE-1 Pivotal Phase
2/3 Trial in Alzheimer's Disease Agitation
significant improvement in Alzheimer's disease agitation, as measured by the CMAI total score
compared to placebo (p=0.010, primary endpoint)
rapi
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AXSM Apr 6, 2020AXSMPhases
Axsome Therapeutics Announces AXS-07 Achieves Both Co-Primary Endpoints and Prevents Migraine Pain Progression in the INTERCEPT Phase 3 Trial in the Early Treatment of Migraine Achieved freedom from migraine pain in 33%
Axsome Therapeutics Announces AXS-07 Achieves Both Co-Primary Endpoints and Prevents Migraine Pain Progression in the INTERCEPT Phase 3 Trial in the Early Treatment of Migraine
Achieved freedom from migraine pain in 33% of AXS-07 patients versus 16% for placebo at 2 hours (co-pr
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AXSM Mar 30, 2020AXSMPhases
Axsome Therapeutics Announces Topline
Axsome Therapeutics Announces Topline
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AXSM Mar 30, 2020AXSMPhases
Axsome Therapeutics Announces Topline Results of the STRIDE-1 Phase 3 Trial in Treatment Resistant Depression and Expert Call to Discuss Clinical Implications Achieves key secondary endpoints demonstrating rapid and stat
Axsome Therapeutics Announces Topline
Results of the STRIDE-1 Phase 3 Trial in Treatment Resistant Depression and Expert Call to Discuss Clinical Implications
Achieves key secondary endpoints demonstrating
rapid and statistically significant improvements in depressive symptoms
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AXSM Mar 20, 2020AXSMPhases
Axsome Therapeutics Accelerates Completion of the ADVANCE-1 Phase 2/3 Trial of AXS-05 in Alzheimer's Disease Agitation Randomizations concluded and trial participation in process of concluding to ensure patient safety du
Axsome Therapeutics Accelerates Completion of the ADVANCE-1 Phase 2/3 Trial of AXS-05 in Alzheimer's Disease Agitation
Randomizations concluded and trial participation in process of concluding to ensure patient safety during COVID-19 pandemic
AXS-05 and placebo arms fully enrol
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AXSM Mar 12, 2020AXSMFDA Updates
Axsome Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update NDA filing for Breakthrough Therapy designated AXS-05 in MDD expected in 4Q 2020 NDA filing for AXS-07 in migra
Axsome Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update
NDA filing for Breakthrough Therapy designated AXS-05 in MDD expected in 4Q 2020
NDA filing for AXS-07 in migraine expected in 4Q 2020
Topline results for STRIDE-1 Phas
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AXSM Mar 12, 2020AXSMConferences/Events
NASDAQ: AXSM March 2020 © Axsome Therapeutics, Inc. Certain information contained in this presentation may include “forward-looking statements” within the meaning of the Private Securities Litigation R
Consists of 3.46 million options and 0.07 million warrants. 27 Our Clinical and Regulatory Milestones Corporate Product Candidate Indication 2019 2020 AXS-05 (DM + BUP) TRD STRIDE-1 Phase 3 topline results (1Q) AD Agitation ADVANCE-1 Phase 2/3 topline results (3Q) MDD ASCEND Phas
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AXSM Mar 5, 2020AXSMGeneral
Axsome Therapeutics Announces the Promotion of Mark Jacobson to Chief Operating Officer
NEW YORK, March 05, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced the appointment of Mark Jacobson as Chief Ope
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AXSM Mar 4, 2020AXSMGeneral
Axsome Therapeutics to Report Fourth Quarter and Full Year 2019 Financial Results on March 12, 2020
Axsome to host conference call and webcast on Thursday, March 12, 2020 at 8:00 AM Eastern Time
NEW YORK, March 04, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of centr
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AXSM Feb 20, 2020AXSMPhases
Axsome Therapeutics Completes Patient Enrollment in the INTERCEPT Phase 3 Trial of AXS-07 in the Early Treatment of Migraine
Axsome Therapeutics Completes Patient Enrollment in the INTERCEPT Phase 3 Trial of AXS-07 in the Early Treatment of Migraine
NEW YORK, February 20, 2020 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapi
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AXSM Jan 22, 2020AXSMPhases
Axsome Therapeutics Completes Patient Randomization in the STRIDE-1 Phase 3 Trial of AXS-05 in Treatment Resistant Depression
Axsome Therapeutics Completes Patient
Randomization in the STRIDE-1 Phase 3 Trial of AXS-05 in Treatment Resistant Depression
NEW YORK, January 22, 2020 (Globe Newswire)
- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel the
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AXSM Jan 13, 2020AXSMPhases
Axsome Therapeutics Enters into Exclusive License Agreement with Pfizer Inc. for Pfizer's Reboxetine Clinical and Nonclinical Data and for New Phase 3 Esreboxetine Product Candidate Agreement accelerates ongoing clinical
Axsome Therapeutics Enters into Exclusive License Agreement with Pfizer Inc. for Pfizer's Reboxetine
Clinical and Nonclinical Data and for New Phase 3 Esreboxetine Product Candidate
Agreement accelerates ongoing
clinical development of AXS-12 (reboxetine) in narcolepsy
Expand
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AXSM Dec 30, 2019AXSMPhases
Axsome Therapeutics Announces AXS-07 Achieves Co-Primary and Key Secondary Endpoints in MOMENTUM Phase 3 Migraine Trial in Patients with History of Inadequate Response Demonstrated statistical significance on regulatory
Axsome Therapeutics Announces AXS-07 Achieves Co-Primary and Key Secondary Endpoints in MOMENTUM Phase 3 Migraine Trial in Patients with History of Inadequate Response
Demonstrated statistical significance on regulatory co-primary endpoints of pain freedom (p<0.001) and freedom
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AXSM Dec 23, 2019AXSMGeneral
Axsome Therapeutics Announces Closing of $200 Million Public Offering of Common Stock, Including Full Exercise of Underwriters' Option to Purchase Additional Shares New York, NY
Therapeutics Announces Closing of $200 Million Public Offering of Common Stock, Including Full Exercise of
Underwriters' Option to Purchase Additional Shares
New York, NY - December 23,
2019 - Axsome Therapeutics, Inc. (NASDAQ: AXSM) ("Axsome"
or the "Company"), a clinical-st
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AXSM Dec 19, 2019AXSMGeneral
Axsome Therapeutics Announces Pricing of Public Offering of 174 Million of Shares of Common Stock
Axsome Therapeutics Announces Pricing of Public Offering of 174 Million of Shares of Common Stock
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AXSM Dec 17, 2019AXSMGeneral
Axsome Therapeutics Added to NASDAQ Biotechnology Index
Axsome Therapeutics Added to NASDAQ Biotechnology Index
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AXSM Dec 16, 2019AXSMPhases
Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in GEMINI Phase 3 Trial in Major Depressive Disorder Demonstrated rapid, durable, and statistically significant improvement in depressive symptoms as measure
Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in GEMINI Phase 3 Trial in Major Depressive Disorder
Demonstrated rapid, durable, and statistically significant improvement in depressive symptoms as measured by MADRS total score compared to placebo (p=0.002 on prim
Read more →
AXSM Dec 3, 2019AXSMPhases
Axsome Therapeutics Announces AXS-12 Achieves Primary Endpoint in CONCERT Phase 2 Trial in Narcolepsy Demonstrated statistically significant reduction in cataplexy attacks compared to placebo (p 0.001 on primary endpoint
Axsome Therapeutics Announces AXS-12
Achieves Primary Endpoint in CONCERT Phase 2 Trial in Narcolepsy
Demonstrated statistically significant
reduction in cataplexy attacks compared to placebo (p<0.001 on primary endpoint)
Reduced excessive daytime sleepiness
compared to plac
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AXSM Nov 21, 2019AXSMGeneral
Axsome Therapeutics to Host Investor R&D Call with Key Opinion Leaders Focusing on AXS-07 and the Unmet Needs in the Acute Treatment of Migraine
Company to host conference call on Monday, November 25 at 9:00 AM Eastern
NEW YORK, Nov. 21, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS
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AXSM Nov 7, 2019AXSMPhases
Axsome Therapeutics Reports Third Quarter 2019 Financial Results and Provides Business Update GEMINI Phase 3 placebo-controlled trial of AXS-05 in MDD completed enrollment and on track for readout of topline results by y
Axsome Therapeutics Reports Third Quarter 2019 Financial Results and Provides Business Update
GEMINI Phase 3 placebo-controlled trial of AXS-05 in MDD completed enrollment and on track for readout of topline results by year-end 2019
STRIDE-1 Phase 3 trial of AXS-05 in TRD to co
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AXSM Nov 7, 2019AXSMConferences/Events
NASDAQ: AXSM November 2019 © Axsome Therapeutics, Inc. Certain information contained in this presentation may include “forward-looking statements” within the meaning of the Private Securities Litigatio
As September 30, 2019 Cash: $43.6 Million Debt (Face Value): $20.0 Million Common Shares Outstanding: 34.5 Million Options and Warrants Outstanding1: 3.3 Million 1. Consists of 3.2 million options and 0.1 million warrants. 29 Clinical Milestones Axsome Therapeutics, Inc. Overview
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AXSM Oct 29, 2019AXSMGeneral
Axsome Therapeutics to Report Third Quarter 2019 Financial Results on November 7, 2019
Axsome to host conference call and webcast on Thursday, November 7, 2019 at 8:00 AM Eastern Time
NEW YORK, Oct. 29, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of cent
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AXSM Oct 28, 2019AXSMGeneral
Axsome Therapeutics Announces Results of MINDSET Physician Survey Affirming Unmet Need and Favorable Profile of AXS-07 in the Acute Treatment of Migraine Majority of physicians indicate improved efficacy is most signific
Axsome Therapeutics Announces Results of MINDSET Physician Survey Affirming Unmet Need and Favorable Profile of AXS-07 in the Acute Treatment of Migraine
Majority of physicians indicate improved efficacy is most significant unmet need in the acute treatment of migraine
Majority
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AXSM Oct 28, 2019AXSMPhases
Axsome Therapeutics Announces Continued Progress in Clinical Development of AXS-07 for the Acute Treatment of Migraine Enrollment in MOMENTUM Phase 3 migraine trial of AXS-07 in patients with history of inadequate respon
Axsome Therapeutics Announces Continued Progress in Clinical Development of AXS-07 for the Acute Treatment of Migraine
Enrollment in MOMENTUM Phase 3 migraine trial of AXS-07 in patients with history of inadequate response nearly complete; on track for topline results in 4Q 2019
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AXSM Oct 21, 2019AXSMPhases
Axsome Therapeutics Completes Patient Enrollment in the CONCERT Phase 2 Trial of AXS-12 in Narcolepsy
Axsome Therapeutics Completes Patient Enrollment in the CONCERT Phase 2 Trial of AXS-12 in Narcolepsy
NEW YORK, October 21, 2019 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of
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AXSM Oct 16, 2019AXSMPhases
Axsome Therapeutics Announces Completion of Patient Enrollment in the GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder
Axsome Therapeutics Announces Completion of Patient Enrollment in the GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder
NEW YORK, October 16, 2019 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel the
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AXSM Oct 2, 2019AXSMPhases
Axsome Therapeutics to Provide Update on Continued Progress at the 2019 Cantor Global Healthcare Conference GEMINI Phase 3 placebo-controlled trial of AXS-05 in MDD on track for readout of topline results in 4Q 2019 STRI
Axsome Therapeutics to Provide Update on Continued Progress at the 2019 Cantor Global Healthcare Conference
GEMINI Phase 3 placebo-controlled trial of AXS-05 in MDD on track for readout of topline results in 4Q 2019
STRIDE-1 Phase 3 trial of AXS-05 in TRD on track for readout o
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AXSM Sep 5, 2019AXSMPhases
Axsome Therapeutics Presents Positive AXS-07 Phase 1 Trial Results at the 19th Congress of the International Headache Society Dual mechanisms, rapid absorption and long half-life support therapeutic potential of AXS-07 i
Axsome Therapeutics Presents Positive AXS-07 Phase 1 Trial Results at the 19th Congress of the
International Headache Society
Dual mechanisms, rapid absorption and long half-life support therapeutic potential of AXS-07 in migraine
AXS-07 MOMENTUM Phase 3 trial ongoing in migra
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AXSM Sep 3, 2019AXSMConferences/Events
Axsome Therapeutics to Present at the Morgan Stanley 17th Annual Global Healthcare Conference
NEW YORK, Sept. 03, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, will participate in the Morgan Stanley 17th Annual Global Hea
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AXSM Aug 20, 2019AXSMGeneral
Axsome Therapeutics Appoints David Marek as Chief Commercial Officer
Axsome Therapeutics Appoints David Marek as Chief Commercial Officer
NEW YORK, August 20, 2019 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) diso
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AXSM Aug 8, 2019AXSMPhases
Axsome Therapeutics Reports Second Quarter 2019 Financial Results and Provides Business Update Both STRIDE-1 Phase 3 trial in TRD and GEMINI Phase 3 trial in MDD for AXS-05 on track for readout of topline results in 2H 2
Axsome Therapeutics Reports Second Quarter 2019 Financial Results and Provides Business Update
Both STRIDE-1 Phase 3 trial in TRD and GEMINI Phase 3 trial in MDD for AXS-05 on track for readout of topline results in 2H 2019
MOMENTUM Phase 3 trial of AXS-07 in migraine on track
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AXSM Jul 30, 2019AXSMGeneral
Axsome Therapeutics To Report Second Quarter 2019 Financial Results On August 8, 2019
Axsome to host conference call and webcast on Thursday, August 8, 2019 at 8:00 AM Eastern Time
NEW YORK, July 30, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of centra
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AXSM Jul 29, 2019AXSMGeneral
Axsome Therapeutics Amends Silicon Valley Bank Loan Agreement Increasing Financial Flexibility Extends interest-only period and time to access additional funding
Axsome Therapeutics Amends Silicon Valley Bank Loan Agreement Increasing Financial Flexibility
Extends interest-only period and time to access additional funding
NEW YORK, July 29, 2019 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutica
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AXSM Jul 1, 2019AXSMGeneral
Axsome Therapeutics Added to Russell 3000 and Russell 2000 Indexes
NEW YORK, July 01, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, has been added to the Russell 3000® and Russell 2000® Indexes,
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AXSM Jun 24, 2019AXSMPhases
Axsome Therapeutics Initiates GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder First patient enrolled in placebo-controlled GEMINI study Topline results anticipated in 2H 2019
Axsome Therapeutics Initiates GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder
First patient enrolled in placebo-controlled GEMINI study
Topline results anticipated in 2H 2019
NEW YORK, June 24, 2019 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clini
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AXSM Jun 7, 2019AXSMPhases
Axsome Therapeutics Provides Update on Continued Progress at Annual Stockholders Meeting Placebo-controlled Phase 3 trial of AXS-05 in MDD on track to start in 2Q 2019 Topline results from both STRIDE-1 Phase 3 trial in
Axsome Therapeutics Provides Update on Continued Progress at Annual Stockholders Meeting
Placebo-controlled Phase 3 trial of AXS-05 in MDD on track to start in 2Q 2019
Topline results from both STRIDE-1 Phase 3 trial in TRD and planned placebo-controlled Phase 3 trial in MDD fo
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AXSM May 21, 2019AXSMPhases
Axsome Therapeutics To Present Data From ASCEND Phase 2 Trial Of AXS-05 In Major Depressive Disorder At The 2019 American Society For Clinical Psychopharmacology Annual Meeting
NEW YORK, May 21, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that data from the Phase 2 ASCEND trial of AXS-
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AXSM May 9, 2019AXSMConferences/Events
Axsome Therapeutics Reports First Quarter 2019 Financial Results and Provides Business Update Company to host conference call today at 8:00 AM Eastern
Axsome Therapeutics Reports First Quarter 2019 Financial Results and Provides Business Update
Company to host conference call today at 8:00 AM Eastern
NEW YORK, May 9, 2019 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company dev
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AXSM May 6, 2019AXSMFDA Updates
Axsome Therapeutics Announces Expedited Development and Pivotal Status for AXS-05 in the Treatment of Major Depressive Disorder based on FDA Breakthrough Therapy Meeting Previously completed active-controlled ASCEND tria
Axsome Therapeutics Announces Expedited Development and Pivotal Status for AXS-05 in the Treatment of Major Depressive Disorder based on FDA Breakthrough Therapy Meeting
Previously completed active-controlled ASCEND trial in MDD now considered as pivotal; sufficient with ongoing
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AXSM May 6, 2019AXSMPhases
Axsome Therapeutics Announces Acceleration of MOMENTUM Phase 3 Trial of AXS-07 in Migraine
Topline results now anticipated in 2H 2019
Trial enriched with only patients with history of inadequate response to prior migraine treatments
Trial compares AXS-07 to placebo and active comparator
Trial being conducted under FDA Special Protocol Assessment (SPA)
Company to di
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AXSM Apr 29, 2019AXSMGeneral
Axsome Therapeutics To Report First Quarter 2019 Financial Results On May 9, 2019
Axsome to host conference call and webcast on Thursday, May 9, 2019 at 8:00 AM Eastern Time
NEW YORK, April 29, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central
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AXSM Apr 15, 2019AXSMPhases
Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in Phase 2 Trial in Smoking Cessation Demonstrated statistically significant reduction in daily smoking compared to active comparator (p=0.0016) Trial conduc
Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in Phase 2 Trial in Smoking Cessation
Demonstrated statistically significant reduction in daily smoking compared to active comparator (p=0.0016)
Trial conducted in collaboration with Duke University
NEW YORK, April
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AXSM Mar 27, 2019AXSMFDA Updates
Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-05 for the Treatment of Major Depressive Disorder Designation offers potential for expedited development and review
Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-05 for the Treatment of Major Depressive Disorder
Designation offers potential for expedited development and review
NEW YORK, March 27, 2019 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a cl
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AXSM Mar 14, 2019AXSMConferences/Events
Axsome Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Business Update Company to host conference call today at 8:00 AM Eastern
Axsome Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Business Update
Company to host conference call today at 8:00 AM Eastern
NEW YORK, March 14, 2019 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmace
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AXSM Mar 6, 2019AXSMGeneral
Axsome Therapeutics Secures $24 Million Growth Capital Loan Facility Led by Silicon Valley Bank $46 million total raised in recent financings extends cash runway into at least 4Q 2021 Current financial position fully fun
Axsome Therapeutics Secures $24 Million Growth Capital Loan Facility Led by Silicon Valley Bank
$46 million total raised in recent financings extends cash runway into at least 4Q 2021
Current financial position fully funds all five ongoing clinical trials
NEW YORK, March 6, 20
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AXSM Mar 5, 2019AXSMGeneral
Axsome Therapeutics to Report Fourth Quarter and Full Year 2018 Financial Results on March 14, 2019
Axsome to host conference call and webcast on Thursday, March 14, 2019 at 8:00 AM Eastern Time
NEW YORK, March 05, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of centr
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AXSM Mar 4, 2019AXSMFDA Updates
Axsome Therapeutics Initiates MOMENTUM Phase 3 Trial of AXS-07 in Migraine First patient enrolled in the MOMENTUM study Trial being conducted under FDA Special Protocol Assessment (SPA) Topline results anticipated in 1Q
Axsome Therapeutics Initiates MOMENTUM Phase 3 Trial of AXS-07 in Migraine
First patient enrolled in the MOMENTUM study
Trial being conducted under FDA Special Protocol Assessment (SPA)
Topline results anticipated in 1Q 2020
NEW YORK, March 4, 2019 (Globe Newswire) Axsome The
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AXSM Feb 6, 2019AXSMFDA Updates
Axsome Therapeutics Receives FDA Agreement under Special Protocol Assessment (SPA) for the MOMENTUM Phase 3 Trial of AXS-07 in Migraine FDA agreement achieved on Phase 3 trial design, endpoints, and statistical approach
Axsome Therapeutics Receives FDA Agreement under Special Protocol Assessment (SPA) for the
MOMENTUM Phase 3 Trial of AXS-07 in Migraine
FDA agreement achieved on Phase 3 trial design, endpoints, and statistical approach
Trial to enroll patients with a history of inadequate res
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AXSM Jan 30, 2019AXSMPhases
Axsome Therapeutics Initiates Phase 2 Trial of AXS-12 in Narcolepsy Topline results anticipated in 2Q 2019
Axsome Therapeutics Initiates Phase 2 Trial of AXS-12 in Narcolepsy
Topline results anticipated in 2Q 2019
NEW YORK, January 30, 2019 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the managem
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AXSM Jan 7, 2019AXSMPhases
Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in Phase 2 Trial in Major Depressive Disorder Demonstrated statistically significant improvement in MADRS scores compared to active comparator (p 0.001 on pr
Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in Phase 2 Trial in Major Depressive Disorder
Demonstrated statistically significant improvement in MADRS scores compared to active comparator (p<0.001 on primary endpoint)
Rapid improvement in depressive symptoms d
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AXSM Jan 7, 2019AXSMConferences/Events
NASDAQ: AXSM January 2019 Axsome Therapeutics, Inc. FLS Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include forward-looking statements within the meaning of the Private
Pharmacokinetic patents More than 25 U.S. and international applications. MoSEIC AXS-06: MoSEIC Meloxicam + Esomeprazole for OA & RA AXS-06 is a fixed-dose combination of MoSEIC meloxicam and esomeprazole Being developed to treat OA and RA, and to reduce the risk of NSAID-associa
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AXSM Jan 7, 2019AXSMGeneral
Axsome Therapeutics Raises $23.3 Million Under Existing ATM Facility
Axsome Therapeutics Raises $23.3 Million Under Existing ATM Facility
NEW YORK, January 7, 2019 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) diso
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AXSM Dec 27, 2018AXSMFDA Updates
Axsome Therapeutics Provides Year End 2018 Clinical Update FDA clearance of IND received for Phase 2 trial of AXS-12 in narcolepsy Phase 2 results of AXS-05 in major depressive disorder on track for early January 2019 Ph
Axsome Therapeutics Provides Year End 2018 Clinical Update
FDA clearance of IND received for Phase 2 trial of AXS-12 in narcolepsy
Phase 2 results of AXS-05 in major depressive disorder on track for early January 2019
Phase 3 results of AXS-05 in treatment resistant depression
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AXSM Dec 18, 2018AXSMConferences/Events
Axsome Therapeutics to Present at Biotech Showcase 2019
NEW YORK, Dec. 18, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Exec
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AXSM Dec 10, 2018AXSMPhases
Axsome Therapeutics Announces Positive Outcome of Interim Analysis of ADVANCE-1 Phase 2/3 Trial of AXS-05 in Alzheimer s Disease Agitation IDMC recommends continuation of trial evaluating AXS-05 versus placebo in Alzheim
Axsome Therapeutics Announces Positive Outcome of Interim Analysis of ADVANCE-1 Phase 2/3 Trial of AXS-05 in Alzheimer s Disease Agitation
IDMC recommends continuation of trial evaluating AXS-05 versus placebo in Alzheimer s disease agitation
IDMC recommends no further enrollme
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AXSM Nov 27, 2018AXSMGeneral
Axsome Therapeutics Expands Loan Agreement with Silicon Valley Bank Providing Additional Growth Capital Related to AXS-12 Product Candidate
Axsome Therapeutics Expands Loan Agreement with Silicon Valley Bank Providing Additional Growth Capital Related to AXS-12 Product Candidate
NEW YORK, November 27, 2018 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developin
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AXSM Nov 19, 2018AXSMConferences/Events
Axsome Therapeutics to Participate in 2018 Global Mizuho Investor Conference
NEW YORK, Nov. 19, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Exec
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AXSM Nov 14, 2018AXSMPhases
Axsome Therapeutics Announces Completion of Patient Enrollment in the ASCEND Phase 2 Trial of AXS-05 in Major Depressive Disorder
Axsome Therapeutics Announces Completion of Patient Enrollment in the ASCEND Phase 2 Trial of AXS-05 in Major Depressive Disorder
NEW YORK, November 14, 2018 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel th
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AXSM Nov 9, 2018AXSMPhases
Axsome Therapeutics Reports Third Quarter 2018 Financial Results and Provides Business Update Final Phase 3 results of AXS-05 in treatment resistant depression now anticipated in 1Q 2019 Final Phase 2 results of AXS-05 i
Axsome Therapeutics Reports Third Quarter 2018 Financial Results and Provides Business Update
Final Phase 3 results of AXS-05 in treatment resistant depression now anticipated in 1Q 2019
Final Phase 2 results of AXS-05 in major depressive disorder anticipated around year-end 20
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AXSM Nov 9, 2018AXSMConferences/Events
NASDAQ: AXSM November 2018 Axsome Therapeutics, Inc. FLS Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include forward-looking statements within the meani ng of the Pri v
NASDAQ: AXSM November 2018 Axsome Therapeutics, Inc.
FLS Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include forward-looking statements within the meani ng of the Pri vate Securities Litigation Reform Act of 1995. We may, in so
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AXSM Nov 1, 2018AXSMGeneral
Axsome Therapeutics to Report Third Quarter 2018 Financial Results on November 9, 2018
Axsome to host conference call and webcast on Friday, November 9, 2018 at 8:00 AM Eastern Time
NEW YORK, Nov. 01, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of centra
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AXSM Oct 18, 2018AXSMConferences/Events
Axsome Therapeutics Hosts R&D Day Today with Key Opinion Leaders Focusing on AXS-05 and Unmet Needs in Alzheimer’s Disease Agitation
NEW YORK, Oct. 18, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, is hosting a research and development (R&D) day in New York Ci
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AXSM Oct 17, 2018AXSMFDA Updates
Axsome Therapeutics Receives FDA Orphan Drug Designation for AXS-12 for the Treatment of Narcolepsy
Axsome Therapeutics Receives FDA Orphan Drug Designation for AXS-12 for the Treatment of Narcolepsy
NEW YORK, October 17, 2018 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of c
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AXSM Oct 17, 2018AXSMGeneral
NASDAQ: AXSM October 2018 Axsome Therapeutics, Inc. FLS Forward-Looking Statements & Safe Harbor Certain information co ntained in this prese ntatio n ma y include forward-looking sta tements within the meani ng of the P
NASDAQ: AXSM October 2018 Axsome Therapeutics, Inc.
FLS Forward-Looking Statements & Safe Harbor Certain information co ntained in this prese ntatio n ma y include forward-looking sta tements within the meani ng of the Pri vate Securities Litigation Refo rm Act of 1995. We ma y,
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AXSM Oct 16, 2018AXSMGeneral
Axsome Therapeutics to Host Call Today with Key Opinion Leader Focusing on AXS-12 and Unmet Needs in Narcolepsy
Conference call and webcast to be held today at 8:00 AM Eastern Time
NEW YORK, Oct. 16, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) diso
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AXSM Oct 16, 2018AXSMPhases
Axsome Therapeutics Announces AXS-12 for the Treatment of Narcolepsy Narcolepsy is a debilitating, orphan neurological condition with limited treatment options Phase 2 trial set to start in 4Q 2018 with results anticipat
Axsome Therapeutics Announces AXS-12 for the Treatment of Narcolepsy
Narcolepsy is a debilitating, orphan neurological condition with limited treatment options
Phase 2 trial set to start in 4Q 2018 with results anticipated in 1H 2019
Conference call and webcast scheduled for t
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AXSM Oct 11, 2018AXSMPhases
Axsome Therapeutics to Focus on Growing Core CNS Portfolio; Establishes Axsome Pain and Primary Care Business Unit to Enhance Value of Non-CNS Assets Axsome PPC to include three novel, non-opioid, Phase 3-stage product c
Axsome Therapeutics to Focus on Growing Core CNS Portfolio; Establishes Axsome Pain and Primary Care Business Unit to Enhance Value of Non-CNS Assets
Axsome PPC to include three novel, non-opioid, Phase 3-stage product candidates for chronic pain
145 issued Axsome PPC patents,
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AXSM Sep 28, 2018AXSMGeneral
Axsome Therapeutics Announces $8.9 Million Registered Direct Offering
Axsome Therapeutics Announces $8.9 Million Registered Direct Offering
NEW YORK, September 28, 2018 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS)
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AXSM Sep 19, 2018AXSMConferences/Events
Axsome Therapeutics to Host R&D Day with Key Opinion Leaders Focused on AXS-05 and Unmet Needs in Alzheimer’s Disease Agitation
NEW YORK, Sept. 19, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it will host a research and development (
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AXSM Aug 28, 2018AXSMConferences/Events
Axsome Therapeutics to Present at the 20th Annual Rodman & Renshaw Global Investment Conference
NEW YORK, Aug. 28, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Exec
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AXSM Aug 8, 2018AXSMConferences/Events
Exhibi t 99.1 NASDAQ: AXSM August 2018 2018, Axsome Therapeutics, Inc. FLS Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include forward-looking statements within the mea
NASDAQ: AXSM August 2018 2018, Axsome Therapeutics, Inc.
FLS Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include forward-looking statements within the meani ng of the Pri vate Securities Litigation Reform Act of 1995. We may, i
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AXSM Aug 8, 2018AXSMPhases
Axsome Therapeutics Reports Second Quarter 2018 Financial Results and Provides Business Update Interim analysis results from two Phase 3 trials and topline results from one Phase 2 trial of AXS-05 anticipated in 4Q 2018
Axsome Therapeutics Reports Second Quarter 2018 Financial Results and Provides Business Update
Interim analysis results from two Phase 3 trials and topline results from one Phase 2 trial of AXS-05 anticipated in 4Q 2018
Phase 3 trial of AXS-07 in acute migraine anticipated to s
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AXSM Aug 1, 2018AXSMGeneral
Axsome Therapeutics to Report Second Quarter 2018 Financial Results on August 8, 2018
Axsome to host conference call and webcast on Wednesday, August 8, 2018 at 8:00 AM Eastern Time
NEW YORK, Aug. 01, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of centr
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AXSM Jul 17, 2018AXSMConferences/Events
Axsome Therapeutics Announces AXS-05 Presentation at the 2018 Alzheimer s Association International Conference
Axsome Therapeutics Announces AXS-05 Presentation at the 2018 Alzheimer s Association International Conference
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AXSM Jun 5, 2018AXSMPhases
Axsome Therapeutics Initiates Phase 2 Trial of AXS-05 in Major Depressive Disorder First patient enrolled in the ASCEND study Trials in two mood disorders now underway with AXS-05
Axsome Therapeutics Initiates Phase 2 Trial of AXS-05 in Major Depressive Disorder
First patient enrolled in the ASCEND study
Trials in two mood disorders now underway with AXS-05
NEW YORK, June 5, 2018 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stag
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AXSM May 29, 2018AXSMConferences/Events
Axsome Therapeutics to Present Data on AXS-05 at the 2018 American Society of Clinical Psychopharmacology Annual Meeting
NEW YORK, May 29, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Phase 1 pharmacokinetic and mechanism of ac
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AXSM May 22, 2018AXSMConferences/Events
Axsome Therapeutics to Present at the 2018 BIO International Convention
NEW YORK, May 22, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Execut
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AXSM May 8, 2018AXSMConferences/Events
Axsome Therapeutics Reports First Quarter 2018 Financial Results and Provides Business Update Company to host conference call today at 8:00 AM Eastern
Axsome Therapeutics Reports First Quarter 2018 Financial Results and Provides Business Update
Company to host conference call today at 8:00 AM Eastern
NEW YORK, May 08, 2018 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company de
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AXSM May 3, 2018AXSMConferences/Events
Axsome Therapeutics Announces AXS-05 Poster Presentation at the 2018 Annual Meeting of the American Psychiatric Association
Axsome Therapeutics Announces AXS-05 Poster Presentation at the 2018 Annual Meeting of the American Psychiatric Association
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AXSM May 1, 2018AXSMGeneral
Axsome Therapeutics to Report First Quarter 2018 Financial Results on May 8, 2018
Axsome to host conference call and webcast on Tuesday, May 8, 2018 at 8:00 AM Eastern Time
NEW YORK, May 01, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nerv
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AXSM Apr 26, 2018AXSMPhases
Axsome Therapeutics Announces Positive Outcome of Interim Analysis of STRIDE-1 Phase 3 Trial of AXS-05 in Treatment Resistant Depression Independent Data Monitoring Committee recommends trial continuation Second interim
Axsome Therapeutics Announces Positive Outcome of Interim Analysis of STRIDE-1 Phase 3 Trial of AXS-05 in Treatment Resistant Depression
Independent Data Monitoring Committee recommends trial continuation
Second interim analysis anticipated second half of 2018 for efficacy
NEW
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AXSM Apr 24, 2018AXSMConferences/Events
Axsome Therapeutics Hosts R&D Day Today with Key Opinion Leaders Focusing on AXS-05 and Unmet Needs in Depression, Alzheimer’s Disease Agitation, and Nicotine Dependence
NEW YORK, April 24, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, is hosting a research and development (R&D) day in New York Ci
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AXSM Apr 23, 2018AXSMPhases
Axsome Therapeutics Announces First Patient Enrolled in Phase 2 Clinical Trial of AXS-05 in Smoking Cessation Trial being conducted in collaboration with Duke University
Axsome Therapeutics Announces First Patient Enrolled in Phase 2 Clinical Trial of AXS-05 in Smoking Cessation
Trial being conducted in collaboration with Duke University
NEW YORK, April 23, 2018 (GLOBE NEWSWIRE) Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharm
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AXSM Apr 19, 2018AXSMGeneral
Axsome Therapeutics Appoints Nick Pizzie, CPA, MBA, as Chief Financial Officer
Axsome Therapeutics Appoints Nick Pizzie, CPA, MBA, as Chief Financial Officer
NEW YORK, April 19, 2018 (GLOBE NEWSWIRE) Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (C
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AXSM Apr 11, 2018AXSMConferences/Events
Axsome Therapeutics to Participate in the Leerink Partners’ 2018 CNS Day
NEW YORK, April 11, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, M.D., Axsome’s Chief Ex
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AXSM Mar 27, 2018AXSMConferences/Events
Axsome Therapeutics to Host R&D Day with Key Opinion Leaders Focused on AXS-05 and Unmet Needs in Depression, Alzheimer’s Disease Agitation, and Nicotine Dependence
NEW YORK, March 27, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it will host a research and development (
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AXSM Mar 26, 2018AXSMConferences/Events
Axsome Therapeutics to Present at H.C. Wainwright Annual Global Life Sciences Conference
NEW YORK, March 26, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, M.D., Axsome’s Chief Ex
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AXSM Mar 19, 2018AXSMConferences/Events
Axsome Therapeutics to Present at 17th Annual Needham Healthcare Conference
NEW YORK, March 19, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, M.D., Axsome’s Chief Ex
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AXSM Mar 12, 2018AXSMConferences/Events
Axsome Therapeutics Presents Scientific Rationale for the Development of AXS-05 at the 20th Annual Meeting of the American Society for Experimental Neurotherapeutics
NEW YORK, March 12, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced presentations on AXS-05, its novel glutamaterg
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AXSM Mar 7, 2018AXSMConferences/Events
Axsome Therapeutics Reports Fourth Quarter and Full Year 2017 Financial Results and Provides Business Update Interim analyses of STRIDE-1 and ADVANCE-1 trials of AXS-05 anticipated in 2018 Company to host conference call
Axsome Therapeutics Reports Fourth Quarter and Full Year 2017 Financial Results and Provides Business Update
Interim analyses of STRIDE-1 and ADVANCE-1 trials of AXS-05 anticipated in 2018
Company to host conference call today at 8:00 AM Eastern
NEW YORK, March 07, 2018 (Globe
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AXSM Feb 28, 2018AXSMGeneral
Axsome Therapeutics to Report Fourth Quarter and Full Year 2017 Financial Results on March 7, 2018
NEW YORK, Feb. 28, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it will report its financial results for f
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AXSM Feb 26, 2018AXSMPhases
Axsome Therapeutics Announces Primary Endpoint Met in Phase 1 Trial of Next Generation Product Candidate AXS-09 Containing Chirally Pure Esbupropion and Dextromethorphan Chirally pure and stable single enantiomers of bup
Axsome Therapeutics Announces Primary Endpoint Met in Phase 1 Trial of Next Generation Product Candidate AXS-09 Containing Chirally Pure Esbupropion and Dextromethorphan
Chirally pure and stable single enantiomers of bupropion achieved
AXS-09 consists of esbupropion and dextrom
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AXSM Feb 5, 2018AXSMConferences/Events
Axsome Therapeutics to Present at 2018 BIO CEO & Investor Conference
NEW YORK, Feb. 05, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, M.D., Axsome’s Chief Exe
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AXSM Jan 9, 2018AXSMPhases
Axsome Therapeutics Announces AXS-02 Independent Data Monitoring Committee Recommends Continuation of COAST-1 Trial and Discontinuation of CREATE-1 Trial COAST-1 is a Phase 3 trial of AXS-02 in knee osteoarthritis associ
Axsome Therapeutics Announces AXS-02 Independent Data Monitoring Committee Recommends Continuation of COAST-1 Trial and Discontinuation of CREATE-1 Trial
COAST-1 is a Phase 3 trial of AXS-02 in knee osteoarthritis associated with bone marrow lesions
CREATE-1 is a Phase 3 trial
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AXSM Dec 19, 2017AXSMConferences/Events
Axsome Therapeutics to Present at Biotech Showcase 2018
NEW YORK, Dec. 19, 2017 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, M.D., Axsome’s Chief Exe
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AXSM Dec 14, 2017AXSMPhases
Axsome Therapeutics Collaborates with World-Leading Nicotine Addiction Research Center for Phase 2 Trial of AXS-05 in Smoking Cessation Builds on preclinical research conducted at Duke University and clinical research co
Axsome Therapeutics Collaborates with World-Leading Nicotine Addiction Research Center for Phase 2 Trial of AXS-05 in Smoking Cessation
Builds on preclinical research conducted at Duke University and clinical research conducted by Axsome
Smoking cessation is the third indicatio
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AXSM Dec 6, 2017AXSMGeneral
Axsome Therapeutics Announces Closing of $9.5 Million Registered Direct Offering
NEW YORK, Dec. 06, 2017 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced the closing of its previously announced registe
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AXSM Dec 1, 2017AXSMGeneral
Axsome Therapeutics Announces $9.5 Million Registered Direct Offering Priced At-the-Market
Axsome Therapeutics Announces $9.5 Million Registered Direct Offering
Priced At-the-Market
NEW YORK, December 1, 2017 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central n
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AXSM Nov 28, 2017AXSMGeneral
Axsome Therapeutics Announces AXS-07 for the Treatment of Migraine
Axsome Therapeutics Announces AXS-07 for the Treatment of Migraine
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AXSM Nov 8, 2017AXSMGeneral
Axsome Therapeutics Reports Third Quarter 2017 Financial Results
Axsome Therapeutics Reports Third Quarter 2017 Financial Results
NEW YORK, Nov. 08, 2017 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders,
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AXSM Sep 18, 2017AXSMConferences/Events
NASDAQ: AXSM September 2017 2017, Axsome Therapeutics, Inc. Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include forward-looking statements within the meani ng of the Pr
NASDAQ: AXSM September 2017 2017, Axsome Therapeutics, Inc.
Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include forward-looking statements within the meani ng of the Pri vate Securities Litigation Reform Act of 1995. We may, in
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AXSM Sep 7, 2017AXSMPhases
Axsome Announces CREATE-1 Interim Analysis Expected Year-End 2017 Interim analysis results for both CREATE-1 and COAST-1 trials anticipated late December to early January
Axsome Announces CREATE-1 Interim Analysis Expected Year-End 2017
Interim analysis results for both CREATE-1 and COAST-1 trials anticipated late December to early January
NEW YORK, September 7, 2017 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage bio
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AXSM Aug 9, 2017AXSMGeneral
Axsome Therapeutics Reports Second Quarter 2017 Financial Results
Axsome Therapeutics Reports Second Quarter 2017 Financial Results
NEW YORK, August 9, 2017 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorder
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AXSM Jul 25, 2017AXSMPhases
Axsome Therapeutics Announces AXS-06 (MoSEIC Meloxicam and Esomeprazole) Meets PrimaryEndpoint in Phase 1 Clinical Trial AXS-06 is an oral, rapidly-absorbed, once-daily, non-opioid, COX-2 preferential pain therapeutic wi
Axsome Therapeutics Announces AXS-06 (MoSEIC Meloxicam and Esomeprazole) Meets PrimaryEndpoint in Phase 1 Clinical Trial
AXS-06 is an oral, rapidly-absorbed, once-daily, non-opioid, COX-2 preferential pain therapeutic with agastroprotectant
Primary endpoint met with 9 times fas
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AXSM Jul 17, 2017AXSMFDA Updates
Axsome Therapeutics Initiates Phase 2/3 Trial of AXS-05 for Alzheimer s Disease Agitation First patient enrolled in the ADVANCE-1 study Agitation reported in nearly 50% of patients with Alzheimer s disease FDA Fast Track
Axsome Therapeutics Initiates Phase 2/3 Trial of AXS-05 for Alzheimer s Disease Agitation
First patient enrolled in the ADVANCE-1 study
Agitation reported in nearly 50% of patients with Alzheimer s disease
FDA Fast Track designation previously received for AXS-05 for Alzheimer
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AXSM Jul 6, 2017AXSMGeneral
Axsome Therapeutics Appoints John Golubieski as Chief Financial Officer
Axsome Therapeutics Appoints John Golubieski as Chief Financial Officer
NEW YORK, July 6, 2017 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) diso
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AXSM Jun 19, 2017AXSMGeneral
Axsome Therapeutics Appoints Myrtle Potter to its Board of Directors
Axsome Therapeutics Appoints Myrtle Potter to its Board of Directors
NEW YORK, June 19, 2017 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disord
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AXSM May 9, 2017AXSMGeneral
Axsome Therapeutics Reports First Quarter 2017 Financial Results
Axsome Therapeutics Reports First Quarter 2017 Financial Results
NEW YORK, May 09, 2017 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders,
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AXSM May 8, 2017AXSMFDA Updates
Axsome Therapeutics Receives FDA Fast Track Designation for AXS-05 for Alzheimer s Disease Agitation
Axsome Therapeutics Receives FDA Fast Track Designation for AXS-05 for Alzheimer s Disease Agitation
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AXSM Mar 31, 2017AXSMConferences/Events
NASDAQ: AXSM April 2017 2017, Axsome Therapeutics, Inc. FLS Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include forward-looking statements within the meani ng of the Pr
NASDAQ: AXSM April 2017 2017, Axsome Therapeutics, Inc.
FLS Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include forward-looking statements within the meani ng of the Pri vate Securities Litigation Reform Act of 1995. We may, in
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AXSM Mar 29, 2017AXSMGeneral
Axsome Therapeutics Announces Full Exercise of Underwriter s Option to Purchase Additional Shares
Axsome Therapeutics Announces Full Exercise of Underwriter s Option to Purchase Additional Shares
NEW YORK, March 29, 2017 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of centr
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AXSM Mar 23, 2017AXSMConferences/Events
Axsome Therapeutics to Present at the 16th Annual Needham Healthcare Conference
NEW YORK, March 23, 2017 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, M.D., Axsome’s Chief Ex
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AXSM Mar 21, 2017AXSMGeneral
Axsome Therapeutics Announces Pricing of Its Public Offering of Common Stock
NEW YORK, March 21, 2017 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced the pricing of its underwritten public offerin
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AXSM Mar 14, 2017AXSMConferences/Events
NASDAQ: AXSM March 2017 2017, Axsome Therapeutics, Inc. FLS Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include forward-looking statements within the meani ng of the Pr
NASDAQ: AXSM March 2017 2017, Axsome Therapeutics, Inc.
FLS Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include forward-looking statements within the meani ng of the Pri vate Securities Litigation Reform Act of 1995. We may, in
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AXSM Mar 7, 2017AXSMPhases
Axsome Therapeutics Reports Fourth Quarter and Full Year 2016 Financial Results and Provides Business Update Interim analysis results from two Phase 3 trials of AXS-02 in separate indications anticipated in 2H 2017 Top-l
Axsome Therapeutics Reports Fourth Quarter and Full Year 2016 Financial Results and Provides Business Update
Interim analysis results from two Phase 3 trials of AXS-02 in separate indications anticipated in 2H 2017
Top-line results from the Phase 3 STRIDE-1 trial of AXS-05 in t
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AXSM Feb 27, 2017AXSMConferences/Events
Axsome Therapeutics to Present at the 29th Annual ROTH Conference
NEW YORK, Feb. 27, 2017 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, M.D., Axsome’s Chief Exe
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AXSM Feb 14, 2017AXSMFDA Updates
Axsome Therapeutics Receives FDA Fast Track Designation for AXS-05 for Treatment Resistant Depression
Axsome Therapeutics Receives FDA Fast Track Designation for AXS-05 for Treatment Resistant Depression
NEW YORK, Feb. 14, 2017 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of ce
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AXSM Feb 13, 2017AXSMConferences/Events
Axsome Therapeutics to Present at the 2017 RBC Capital Markets Global Healthcare Conference
NEW YORK, Feb. 13, 2017 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, M.D., Axsome’s Chief Exe
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AXSM Feb 10, 2017AXSMConferences/Events
NASDAQ: AXSM February 2017 2017, Axsome Therapeutics, Inc. FLS Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include forward-looking statements within the meani ng of the
NASDAQ: AXSM February 2017 2017, Axsome Therapeutics, Inc.
FLS Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include forward-looking statements within the meani ng of the Pri vate Securities Litigation Reform Act of 1995. We may,
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AXSM Feb 7, 2017AXSMConferences/Events
Axsome Therapeutics to Present at the 2017 BIO CEO Investor Conference
Axsome Therapeutics to Present at the 2017 BIO CEO Investor Conference
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AXSM Jan 12, 2017AXSMConferences/Events
NASDAQ: AXSM January 2017 2016, Axsome Therapeutics, Inc. FLS Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include forward-looking statements within the meani ng of the
NASDAQ: AXSM January 2017 2016, Axsome Therapeutics, Inc.
FLS Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include forward-looking statements within the meani ng of the Pri vate Securities Litigation Reform Act of 1995. We may,
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AXSM Jan 4, 2017AXSMConferences/Events
Axsome Therapeutics to Present at Biotech Showcase 2017
NEW YORK, Jan. 04, 2017 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, M.D., Axsome’s Chief Exe
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AXSM Jan 3, 2017AXSMFDA Updates
Axsome Therapeutics Receives FDA Clearance of IND for Phase 2/3 Trial of AXS-05 in Alzheimer s Disease Agitation
Axsome Therapeutics Receives FDA Clearance of IND for Phase 2/3 Trial of AXS-05 in Alzheimer s Disease Agitation
NEW YORK, January 3, 2017 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the man
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AXSM Nov 14, 2016AXSMGeneral
Axsome Therapeutics Reports Third Quarter 2016 Financial Results
Axsome Therapeutics Reports Third Quarter 2016 Financial Results
NEW YORK, November 14, 2016 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disord
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AXSM Nov 10, 2016AXSMGeneral
Axsome Therapeutics Enters into $20 Million Term Loan Agreement with Silicon Valley Bank
Axsome Therapeutics Enters into $20 Million Term Loan Agreement with Silicon Valley Bank
NEW YORK, November 10, 2016 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central ner
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AXSM Oct 4, 2016AXSMGeneral
Axsome Therapeutics Announces Publication of Research Showing AXS-02 Inhibits Pain in Animal Model of Complex Regional Pain Syndrome
NEW YORK, Oct. 04, 2016 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced the publication of data showing that AXS-02 (or
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AXSM Sep 19, 2016AXSMConferences/Events
Axsome Therapeutics to Present at the Ladenburg Thalmann 2016 Healthcare Conference
NEW YORK, Sept. 19, 2016 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, M.D., Axsome’s Chief Ex
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AXSM Sep 2, 2016AXSMGeneral
Axsome Therapeutics Announces Transition of Chief Medical Officer
Axsome Therapeutics Announces Transition of Chief Medical Officer
NEW YORK, September 2, 2016 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disor
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AXSM Aug 9, 2016AXSMGeneral
Axsome Therapeutics Reports Second Quarter 2016 Financial Results
Axsome Therapeutics Reports Second Quarter 2016 Financial Results
NEW YORK, August 9, 2016 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorder
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AXSM Jul 13, 2016AXSMConferences/Events
NASDAQ: AXSM Cantor Fitzgerald 2nd Annual Healthcare Conference July 2016 2016, Axsome Therapeutics, Inc. FLS Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include forwar
NASDAQ: AXSM Cantor Fitzgerald 2nd Annual Healthcare Conference July 2016 2016, Axsome Therapeutics, Inc.
FLS Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include forward-looking statements within the meaning of the Private Secu
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AXSM Jul 5, 2016AXSMConferences/Events
Axsome Therapeutics to Present at the Cantor Fitzgerald 2nd Annual Healthcare Conference
NEW YORK, July 05, 2016 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, M.D., Axsome’s Chief Exe
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AXSM Jun 13, 2016AXSMConferences/Events
Axsome Therapeutics to Present at the 2016 JMP Securities Life Sciences Conference
Axsome Therapeutics to Present at the 2016 JMP Securities Life Sciences Conference
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AXSM May 11, 2016AXSMGeneral
Axsome Therapeutics Reports First Quarter 2016 Financial Results
Axsome Therapeutics Reports First Quarter 2016 Financial Results
NEW YORK, May 11, 2016 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders,
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AXSM May 3, 2016AXSMFDA Updates
Axsome Therapeutics Receives FDA Fast Track Designation for AXS-02 for the Treatment of the Pain of Knee Osteoarthritis Associated with Bone Marrow Lesions
Axsome Therapeutics Receives FDA Fast Track Designation for AXS-02 for the Treatment of the Pain of Knee Osteoarthritis Associated with Bone Marrow Lesions
NEW YORK, May 3, 2016 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company
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AXSM Apr 20, 2016AXSMFDA Updates
Axsome Therapeutics Receives Pre-IND Guidance from FDA for AXS-05 for Agitation in Patients with Alzheimer s Disease Phase 2/3 Trial Planned in Agitation in Alzheimer s Disease IND Submission Expected in 2016
Axsome Therapeutics Receives Pre-IND Guidance from FDA for AXS-05 for Agitation in Patients with Alzheimer s Disease
Phase 2/3 Trial Planned in Agitation in Alzheimer s Disease
IND Submission Expected in 2016
NEW YORK, April 20, 2016 (Globe Newswire) Axsome Therapeutics, Inc.
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AXSM Apr 4, 2016AXSMConferences/Events
Axsome Therapeutics to Present at the 15th Annual Needham Healthcare Conference
NEW YORK, April 04, 2016 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, M.D., Axsome’s Chief Ex
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AXSM Mar 28, 2016AXSMPhases
Axsome Therapeutics Initiates Phase 3 Study of AXS-02 for Knee Osteoarthritis Associated with Bone Marrow Lesions
First Patient Enrolled in the COAST-1 Study
Non-Opioid, Oral, Targeted, Potentially First-in-Class Mechanism for Pain
Novel Biomarker-Based Approach for the Treatment of Knee Osteoarthritis Pain
COAST-1 Study Being Conducted under FDA Special Protocol Assessment
NEW YORK, Mar
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AXSM Mar 24, 2016AXSMGeneral
Axsome Therapeutics Reports Fourth Quarter and Full Year 2015 Financial Results
Axsome Therapeutics Reports Fourth Quarter and Full Year 2015 Financial Results
NEW YORK, March 24, 2016 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system
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AXSM Mar 17, 2016AXSMPhases
Axsome Therapeutics Initiates Phase 3 Study of AXS-05 for Treatment Resistant Depression First Patient Enrolled in the STRIDE-1 Study Second Product Candidate Axsome Has Advanced into a Pivotal Trial
Axsome Therapeutics Initiates Phase 3 Study of AXS-05 for Treatment Resistant Depression
First Patient Enrolled in the STRIDE-1 Study
Second Product Candidate Axsome Has Advanced into a Pivotal Trial
NEW YORK, March 17, 2016 (Globe Newswire) Axsome Therapeutics, Inc. (NASDAQ:
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AXSM Mar 15, 2016AXSMGeneral
Axsome Therapeutics Receives New U.S. Patent Covering AXS-02 for the Treatment of Complex Regional Pain Syndrome
Provides Patent Protection for AXS-02 into 2033
Covers Uses of Oral Zoledronic Acid for Complex Regional Pain Syndrome
Represents the 19th Issued Patent Covering AXS-02 or Related Compounds
NEW YORK, March 15, 2016 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a
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AXSM Feb 22, 2016AXSMGeneral
Axsome Therapeutics, Inc. (Nasdaq: AXSM) to Ring The Nasdaq Stock Market Opening Bell
ADVISORY, Feb. 22, 2016 (GLOBE NEWSWIRE) --
Axsome Therapeutics, Inc. (Nasdaq:AXSM), a clinical stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, will visit the Nasdaq MarketSite in Times Square to celebrate
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AXSM Feb 1, 2016AXSMConferences/Events
Axsome Therapeutics to Present at the 2016 BIO CEO & Investor Conference
NEW YORK, Feb. 01, 2016 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, M.D., Axsome’s Chief Exe
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AXSM Jan 27, 2016AXSMGeneral
Axsome Therapeutics Announces Issuance of U.S. Patent Covering AXS-02 for the Treatment of Bone Marrow Lesions of the Knee
Provides Patent Protection into 2033
NEW YORK, Jan. 27, 2016 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that the
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AXSM Jan 4, 2016AXSMConferences/Events
Axsome Therapeutics to Present at Biotech Showcase 2016
NEW YORK, Jan. 04, 2016 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical stage biopharmaceutical company developing novel therapies for the management of pain and other central nervous system (CNS) disorders, today announced that Herriot Tabuteau, M.D., Axs
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AXSM Nov 24, 2015AXSMGeneral
Axsome Therapeutics Announces Closing of Initial Public Offering
NEW YORK, Nov. 24, 2015 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical stage biopharmaceutical company developing novel therapies for the management of pain and other central nervous system (CNS) disorders, today announced the closing of its initial publi
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AXSM Nov 19, 2015AXSMGeneral
Axsome Therapeutics Announces Pricing of Initial Public Offering
Axsome Therapeutics Announces Pricing of Initial Public Offering
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AXSM Aug 10, 2015AXSMPhases
Axsome Therapeutics Announces Enrollment of the First Patient in a Phase 3 Trial of AXS-02 for Complex Regional Pain Syndrome CRPS
Axsome Therapeutics Announces Enrollment of the First Patient in a Phase 3 Trial of AXS-02 for Complex Regional Pain Syndrome CRPS
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AXSM Apr 9, 2015AXSMGeneral
Axsome Therapeutics Announces Appointment of Randall Kaye M D as Chief Medical Officer
Axsome Therapeutics Announces Appointment of Randall Kaye M D as Chief Medical Officer
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AXSM Mar 19, 2015AXSMGeneral
Axsome Therapeutics Appoints World Leading Experts to Depression Scientific Advisory Board
NEW YORK, March 19, 2015 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc., a biopharmaceutical company developing novel therapies for the treatment of pain and other central nervous system (CNS) disorders, today announced the formation of its Depression Scientific Advisory Board ("D
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AXSM Mar 5, 2015AXSMFDA Updates
Axsome Therapeutics Announces FDA Fast Track Designation for AXS-02 for the Treatment of Pain Associated With Complex Regional Pain Syndrome
Axsome Therapeutics Announces FDA Fast Track Designation for AXS-02 for the Treatment of Pain Associated With Complex Regional Pain Syndrome
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AXSM Sep 17, 2014AXSMGeneral
Axsome Therapeutics Announces Appointments to Its Board of Directors
NEW YORK, Sept. 17, 2014 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. today announced that Roger Jeffs, Ph.D., Mark Saad, and Mark Coleman, M.D. will join its Board of Directors.
Dr. Jeffs is President and Chief Operating Officer (COO) of United Therapeutics Corporation (Nasdaq
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