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 3, 2026AXSMFDA Updates
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 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
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 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 Feb 25, 2026AXSMConferences/Events
Axsome Therapeutics to Participate in Upcoming Investor Conferences
Axsome Therapeutics announced its participation in several investor conferences scheduled for March. The company will provide live webcasts of its presentations, which will be accessible for 30 days post-event. Axsome is committed to addressing central nervous system disorders and has a portfolio that includes FDA-approved treatments for various 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 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 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 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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