DNLI Jul 9, 2026DNLIConferences/Events
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Denali Therapeutics to Give Opening Plenary Address at Alzheimer’s Association International Conference (AAIC) 2026 and Highlight Breakthroughs in Delivering Biologic Therapies Across Blood-Brain Barrier
Denali Therapeutics will present at the Alzheimer's Association International Conference 2026, focusing on breakthroughs in delivering therapies across the blood-brain barrier. CEO Ryan Watts will discuss advancements in neurodegenerative disease treatments, including investigational therapies DNL628 and DNL921. Denali's proprietary TransportVehicle™ technology aims to enhance drug delivery to the brain.
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DNLI Jun 18, 2026DNLIFDA Updates
Denali Therapeutics Enters Agreement to Sell Rare Pediatric Disease Priority Review Voucher for $195 Million
Denali Therapeutics has announced a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher for $195 million. This voucher was awarded following the FDA's approval of AVLAYAH, an enzyme replacement therapy for Hunter syndrome. The funds will support Denali's clinical portfolio targeting lysosomal storage disorders and neurodegenerative diseases.
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DNLI May 21, 2026DNLIPhases
Biogen and Denali Therapeutics Provide Update on Phase 2b LUMA Study of BIIB122 (DNL151) in Early-Stage Parkinson's Disease The Phase 2b LUMA study of BIIB122 in early-stage Parkinson's disease did not meet its primary o
Biogen and Denali Therapeutics announced that the Phase 2b LUMA study of BIIB122 (DNL151) for early-stage Parkinson's disease failed to meet its primary and secondary endpoints, prompting the discontinuation of the drug's development for idiopathic Parkinson's disease. Despite this setback, exploratory biomarker data showed promising kinase inhibition, and Denali plans to continue the Phase 2a BEACON study focused on patients with a specific LRRK2 variant. Findings from the LUMA study will be presented at an upcoming scientific conference for greater understanding of Parkinson's disease.
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DNLI May 7, 2026DNLIFDA Updates
Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights
Denali Therapeutics reported its Q1 2026 financial results, highlighting the FDA approval of AVLAYAH for Hunter syndrome. The company launched AVLAYAH in the U.S. with strong momentum, and its clinical pipeline is advancing, including therapies for Alzheimer's and frontotemporal dementia. Despite a net loss of $128.4 million, Denali remains focused on its innovative TransportVehicle platform and upcoming studies.
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DNLI Apr 3, 2026DNLIPhases
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Denali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)
Denali Therapeutics has regained full rights to DNL593 after Takeda terminated their collaboration. The investigational therapy aims to deliver progranulin to the brain for treating frontotemporal dementia (FTD-GRN). Denali plans to continue its clinical development independently and expects results from the ongoing Phase 1/2 study by the end of 2026.
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DNLI Mar 25, 2026DNLIFDA Updates
Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)
Denali Therapeutics has received FDA approval for AVLAYAH (tividenofusp alfa-eknm), the first enzyme replacement therapy specifically targeting Hunter syndrome, a rare genetic disorder. This marks a significant advancement as it is the first FDA-approved treatment in nearly two decades designed to penetrate the blood-brain barrier. The approval is based on promising results from a Phase 1/2 trial, with ongoing studies to confirm clinical benefits.
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DNLI Feb 26, 2026DNLIGeneral
Denali Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights Tividenofusp alfa (DNL310 ETV IDS) launch readiness established ahead of
Denali Therapeutics has reported its fourth quarter and full year 2025 financial results, highlighting significant advancements in its clinical programs. The company is preparing for the launch of tividenofusp alfa for Hunter syndrome, with a PDUFA date set for April 5, 2026. Preliminary data presented for DNL126 indicate potential for accelerated approval in Sanfilippo syndrome type A. Additionally, Denali is advancing studies for treatments targeting Alzheimer's disease and Pompe disease, while managing fiscal challenges reflected in increased net losses.
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DNLI Feb 5, 2026DNLIPhases
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Denali Therapeutics Presents Enzyme TransportVehicle™ Progress Across Three Clinical Programs for Treatment of Lysosomal Storage Disorders at 2026 WORLDSymposium™
Denali Therapeutics presented updates on its Enzyme TransportVehicle™ (ETV) programs targeting lysosomal storage disorders at the WORLDSymposium. Notable findings include substantial reductions in disease biomarkers for DNL310 in Hunter syndrome and DNL126 in Sanfilippo syndrome type A, suggesting their efficacy. The company is preparing for a potential commercial launch of tividenofusp alfa by April 5, 2026, alongside ongoing studies for DNL952 in Pompe disease. The data reinforce the potential of Denali's therapies to address significant unmet needs in patients with these debilitating conditions.
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DNLI Feb 2, 2026DNLIConferences/Events
Denali Therapeutics To Host Webcast Highlighting Presentations on Enzyme TransportVehicle™ Programs at the 2026 WORLDSymposium™
Denali Therapeutics announced a live webcast to discuss its Enzyme TransportVehicle™ programs at the 22nd Annual WORLDSymposium™. The event will take place from February 2-6, 2026, in San Diego, California. The webcast aims to highlight the potential of enzyme replacement therapies to deliver treatment throughout the body, including the brain.
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DNLI Jan 30, 2026DNLIConferences/Events
Denali Therapeutics Announces Data Presentations on Enzyme TransportVehicle™ Programs for Hunter Syndrome, Sanfilippo Syndrome Type A and Pompe Disease at Upcoming 2026 WORLDSymposium™
Denali Therapeutics announced that it will present data on its Enzyme TransportVehicle™ programs at the 2026 WORLDSymposium™. The presentations will include follow-up data from ongoing Phase 1/2 studies for Hunter syndrome and Sanfilippo syndrome type A, as well as details on a Phase 1 study for Pompe disease. The FDA is reviewing the Biologics License Application for tividenofusp alfa, with a decision expected by April 2026.
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DNLI Jan 6, 2026DNLIFDA Updates
▲ +7.4%on this news
Denali Therapeutics Announces Key Anticipated Milestones and Priorities for 2026 Including Commercial Launch of Tividenofusp Alfa for Hunter Syndrome Preparing for FDA approval and commercial launch of tividenofusp alfa,
Denali Therapeutics has announced key milestones and priorities for 2026, including the anticipated commercial launch of tividenofusp alfa for Hunter syndrome. The company is preparing for an FDA decision on the drug's accelerated approval, with a projected action date of April 5, 2026. Additionally, Denali plans to initiate clinical trials for new therapies targeting Alzheimer's disease and Pompe disease while also expecting multiple clinical data readouts that could enhance their portfolio's value in neurodegenerative and lysosomal storage diseases.
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DNLI Dec 30, 2025DNLIPhases
The New England Journal of Medicine Publishes Phase 1/2 Study of Denali Therapeutics’ Tividenofusp Alfa (DNL310) for Hunter Syndrome (MPS II)
Denali Therapeutics announced the publication of Phase 1/2 trial results for tividenofusp alfa, an enzyme replacement therapy for Hunter syndrome, in The New England Journal of Medicine. The FDA is reviewing the Biologics License Application for accelerated approval, with a decision expected by April 2026. The therapy aims to address both cognitive and physical symptoms of the disease, which currently lacks effective treatment options.
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DNLI Dec 10, 2025DNLIGeneral
▼ -10.6%on this news
Denali Therapeutics Announces Pricing of Public Offering of Common Stock and Pre-Funded Warrants
Denali Therapeutics has announced the pricing of its public offering, aiming to sell over 9 million shares of common stock at $17.50 each, alongside pre-funded warrants. The company anticipates total gross proceeds of around $200 million before expenses related to the offering. Notably, underwriters have a 30-day option to purchase additional shares, showcasing confidence in demand. The offering is expected to close on or about December 11, 2025, pending customary closing conditions.
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DNLI Dec 9, 2025DNLIGeneral
Denali Therapeutics Announces Proposed Offering of Common Stock and Pre-Funded Warrants
Denali Therapeutics announced a proposed offering of $200 million in common stock and pre-funded warrants, subject to market conditions. The underwriters include major banks such as Goldman Sachs and J.P. Morgan. This move is part of their strategy to secure funding for their biotherapeutics aimed at addressing neurodegenerative diseases. However, the uncertainty of market conditions may impact the actual outcome of the offering.
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DNLI Dec 4, 2025DNLIGeneral
▲ +5.8%on this newsshared move
Denali Therapeutics and Royalty Pharma Announce $275 Million Royalty Funding Agreement
Denali Therapeutics has entered into a $275 million royalty funding agreement with Royalty Pharma focusing on future sales of its investigational enzyme replacement therapy, tividenofusp alfa, for Hunter syndrome. The agreement is pending U.S. FDA accelerated approval due in April 2026, which is crucial for the transaction's activation. This funding will assist Denali in further development programs, promising advancements in the treatment of cognitive and physical challenges associated with Hunter syndrome.
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DNLI Nov 6, 2025DNLIGeneral
Denali Therapeutics Reports Third Quarter 2025 Financial Results and Business Highlights
Denali Therapeutics reported its Q3 2025 financial results, highlighting a net loss of $126.9 million. The company is gearing up for the launch of tividenofusp alfa and has submitted regulatory applications for clinical studies in Alzheimer's and Pompe diseases. Additionally, Denali's pipeline continues to expand with multiple promising therapies under development.
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DNLI Nov 6, 2025DNLIGeneral
Denali Therapeutics Announces Board and Executive Leadership Updates
Denali Therapeutics has announced significant updates to its leadership team, including the appointment of Tim Van Hauwermeiren to the Board of Directors and the transition of Peter Chin to Acting Chief Medical Officer. Carole Ho will be leaving to join Eli Lilly as Executive Vice President. The changes come as Denali prepares for the potential commercialization of its first product, tividenofusp alfa.
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DNLI Oct 13, 2025DNLIFDA Updates
Denali Therapeutics Announces FDA Review Extension of BLA for Tividenofusp Alfa for the Treatment of MPS II (Hunter Syndrome)
Denali Therapeutics announced an extension of the FDA review timeline for its Biologics License Application for tividenofusp alfa, aimed at treating Hunter syndrome. The new Prescription Drug User Fee Act target date is now April 5, 2026. This extension follows the submission of updated clinical pharmacology information but does not relate to efficacy or safety concerns. Denali remains optimistic about the approval process and its commitment to the MPS community.
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DNLI Aug 11, 2025DNLIFDA Updates
Denali Therapeutics Reports Second Quarter 2025 Financial Results and Business Highlights Tividenofusp alfa BLA for Hunter syndrome accepted for priority review and assigned PDUFA target action date of
Denali Therapeutics reported its second-quarter 2025 financial results and highlighted key business developments. The FDA accepted the Biologics License Application for tividenofusp alfa for Hunter syndrome for priority review, with a PDUFA action date set for January 5, 2026. Denali is also preparing for the commercial launch of this investigational therapy. Furthermore, the company is advancing its DNL126 program for Sanfilippo syndrome Type A with a favorable path toward accelerated approval.
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DNLI Jul 7, 2025DNLIFDA Updates
Denali Therapeutics Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Tividenofusp Alfa for Hunter Syndrome (MPS II) FDA assigns PDUFA target action date of
Denali Therapeutics has announced that the FDA has accepted its Biologics License Application for tividenofusp alfa, aimed at treating Hunter syndrome. The application has been granted Priority Review, with a PDUFA target action date set for January 5, 2026. This investigational therapy is designed to deliver the missing enzyme directly into the brain and body, which current treatments do not do. Apart from its potential role in treating Hunter syndrome, this approval marks a pivotal moment for Denali's TransportVehicle platform, indicating a broader ambition to tackle more lysosomal storage diseases.
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DNLI May 6, 2025DNLIFDA Updates
Denali Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights Including Completion of BLA Rolling Submission for Tividenofusp Alfa for Hunter Syndrome
Denali Therapeutics reported its Q1 2025 financial results, highlighting the completion of the BLA submission for tividenofusp alfa, a potential treatment for Hunter syndrome. The company is preparing for a commercial launch in late 2025 or early 2026. Despite a net loss increase, Denali continues to advance its clinical programs and expand its manufacturing capabilities.
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DNLI Apr 2, 2025DNLIFDA Updates
▲ +11.8%on this news
Denali Therapeutics Announces Initiation of BLA Filing for Accelerated Approval of Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II) and Positive Ongoing Interactions with FDA on DNL126 Through START Progra
Denali Therapeutics has initiated the rolling submission of a Biologics License Application (BLA) for accelerated approval of its therapy, tividenofusp alfa, aimed at treating Hunter syndrome. The company is working closely with the FDA’s Center for Drug Evaluation and Research to ensure alignment on necessary data and potential approval timelines. A commercial launch is anticipated as early as late 2025. In addition, ongoing collaboration under the START program is facilitating a promising development pathway for DNL126, which targets Sanfilippo syndrome.
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DNLI Feb 27, 2025DNLIGeneral
Denali Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights SOUTH SAN FRANCISCO, Calif.
Denali Therapeutics has reported its financial results for the fourth quarter and full year of 2024, highlighting substantial advancements in its Enzyme Transport Vehicle (ETV) programs. The company is preparing for the potential launch of tividenofusp alfa, targeted for Hunters syndrome, with an application for accelerated approval due in early 2025. However, Denali faced increased net losses and a significant drop in collaboration revenue compared to the previous year. The firm aims to enhance its portfolio by advancing one to two programs into the clinic annually over the next three years.
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DNLI Feb 6, 2025DNLIPhases
Denali Therapeutics Announces Primary Analysis and Long-Term Follow-Up of Phase 1/2 Study in Hunter Syndrome (MPS II) with Tividenofusp Alfa
Denali Therapeutics announced positive results from its Phase 1/2 study of tividenofusp alfa for Hunter syndrome, showing significant improvements in key biomarkers and clinical outcomes. The company plans to submit a biologics license application in early 2025, aiming for accelerated approval. The treatment was generally well tolerated, with manageable adverse events reported.
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DNLI Jan 30, 2025DNLIConferences/Events
Denali Therapeutics Announces Upcoming Presentations on Hunter Syndrome (MPS II) and TransportVehicle™ Enabled Investigational Therapeutic Tividenofusp Alfa at the 2025 WORLDSymposium™
Denali Therapeutics announced its participation in the 2025 WORLDSymposium, where it will present clinical results for its investigational therapy, tividenofusp alfa, aimed at treating Hunter syndrome (MPS II). The presentations will include an oral session on efficacy and safety, as well as several poster sessions. Denali's TransportVehicle platform is designed to enhance therapeutic delivery across the blood-brain barrier.
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DNLI Jan 13, 2025DNLIFDA Updates
Denali Therapeutics Announces Key Anticipated 2025 Milestones and Priorities to Further Advance Its Therapeutics Portfolio for Neurodegeneration and Lysosomal Storage Diseases FDA Breakthrough Therapy Designation receive
Denali Therapeutics has announced significant milestones anticipated for 2025, including the submission of a biologics license application for tividenofusp alfa for Hunter syndrome, which has received FDA Breakthrough Therapy Designation. The company is also preparing for its commercial launch, slated for late 2025 or early 2026. Additionally, Denali plans to seek FDA alignment for accelerated approval of its DNL126 program for Sanfilippo syndrome and to advance its platform of TransportVehicleTM enabled therapies. Their portfolio expansion aims to provide treatment options for both neurodegenerative and lysosomal storage diseases.
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DNLI Jan 8, 2025DNLIFDA Updates
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)
Denali Therapeutics announced that the U.S. FDA granted Breakthrough Therapy Designation to its investigational drug tividenofusp alfa (DNL310) for treating Hunter syndrome (MPS II). This designation adds to previous recognitions including Fast Track and Orphan Drug designations. The drug has shown promising results in early clinical studies, and Denali plans to submit a Biologics License Application in early 2025. The designation is aimed at expediting the development of therapies that have shown substantial improvement over existing treatments.
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DNLI Jan 6, 2025DNLIPhases
▼ -6.8%on this newsshared move
Denali Therapeutics Announces Topline Results for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2 3 HEALEY ALS Platform Trial Primary endpoint of overall function (ALSFRS-R) and survival, and key secondary endpo
Denali Therapeutics has announced topline results from the Phase 2 3 HEALEY ALS Platform Trial evaluating its eIF2B agonist DNL343. Unfortunately, the trial did not meet the primary endpoint of efficacy in slowing ALS disease progression, nor did it show statistical differences in key secondary measures such as muscle strength and respiratory function. Nonetheless, the drug was reported as safe and well tolerated, with further analyses on biomarkers and treatment extension forthcoming in 2025. This outcome highlights ongoing challenges in developing effective therapies for ALS.
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DNLI Dec 5, 2024DNLIPhases
Denali Therapeutics Announces First Participant Dosed in Phase 2a Study of LRRK2 Inhibitor, BIIB122, in LRRK2-Associated Parkinson’s Disease
Denali Therapeutics has announced the commencement of dosing in its Phase 2a clinical study, named BEACON, which evaluates the safety and biomarkers of the LRRK2 inhibitor BIIB122 in participants with LRRK2-associated Parkinson's disease. This study aims to enroll approximately 50 participants and involves a double-blind treatment period followed by an open-label extension. Denali is leading the study's design and execution, with financial support from a third-party agreement. The findings from this study could provide important insights into the therapeutic potential of LRRK2 inhibition for Parkinson's disease.
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DNLI Nov 6, 2024DNLIGeneral
▲ +6.9%on this news
Denali Therapeutics Reports Third Quarter 2024 Financial Results and Business Highlights SOUTH SAN FRANCISCO, Calif.
Denali Therapeutics reported its third quarter 2024 financial results, highlighting significant progress in its clinical portfolio. The company is on track to submit a biologics license application for tividenofusp alfa in MPS II, aiming for accelerated approval in early 2025. Preliminary data from the DNL126 study in MPS IIIA has shown promising outcomes with reduced CSF heparan sulfate levels. However, the company also faced challenges, including increased net losses and the discontinuation of the K2 Phase 2 study for SAR443820 due to unmet efficacy endpoints.
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DNLI Sep 3, 2024DNLIFDA Updates
Denali Therapeutics Announces Successful Meeting with the FDA and Plans to File for Accelerated Approval of Tividenofusp Alfa (DNL310) for the Treatment of MPS II (Hunter Syndrome)
Denali Therapeutics announced a successful meeting with the FDA that paves the way for filing a biologics license application (BLA) for accelerated approval of tividenofusp alfa (DNL310) for the treatment of MPS II. The company plans to submit the BLA in early 2025, supported by preclinical and clinical data demonstrating favorable biomarkers. New Phase 1/2 data will be presented at the SSIEM conference, showcasing significant reductions in disease biomarkers and improvements in clinical outcomes. Tividenofusp alfa's safety profile appears robust, indicating its potential as a therapy for this rare genetic condition.
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DNLI Aug 14, 2024DNLIGeneral
Denali Therapeutics Announces Publication in Science Translational Medicine Demonstrating the Potential of the Oligonucleotide Transport Vehicle Platform to Achieve Broad Biodistribution of Antisense Oligonucleotides in the CNS and Muscle Following Intravenous Administration
Denali Therapeutics announced the publication of nonclinical data in 'Science Translational Medicine' that highlights the effectiveness of their Oligonucleotide Transport Vehicle (OTV) platform. The study reveals that OTV can deliver antisense oligonucleotides to achieve broad biodistribution in the central nervous system and muscle following intravenous administration. This represents a significant advancement in addressing the challenges posed by the blood-brain barrier in drug delivery, supporting future development of treatments for Alzheimer's and Parkinson's diseases.
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DNLI Aug 1, 2024DNLIGeneral
Denali Therapeutics Reports Second Quarter 2024 Financial Results and Business Highlights SOUTH SAN FRANCISCO, Calif.
Denali Therapeutics reported its financial results for the second quarter of 2024, highlighting key business developments in neurodegenerative disease treatments. The company is engaged with the FDA on accelerated approval pathways for several product candidates and regained rights to its ATV Abeta program from Biogen. However, it faced a net loss of $99 million in the quarter, a sharp decline in revenue compared to the previous year due to the absence of collaboration revenue. The ongoing engagement in clinical trials and strong pipeline activity indicates potential future growth despite current financial challenges.
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DNLI Jun 3, 2024DNLIFDA Updates
▲ +9.8%on this news
Denali Therapeutics Announces FDA Has Selected DNL126 (ETV:SGSH) for MPS IIIA (Sanfilippo Syndrome Type A) for START Pilot Program Intended to Accelerate Development of Rare Disease Therapies
Denali Therapeutics has announced that the FDA has selected its investigational enzyme replacement therapy, DNL126, for the START Pilot Program aimed at accelerating the development of therapies for rare diseases like MPS IIIA. This selection is significant as it allows for more rapid communication with FDA staff and is intended to streamline development processes. Denali is actively conducting a Phase 1/2 study of DNL126, addressing the urgent needs of patients with Sanfilippo syndrome Type A, a condition currently lacking approved treatments.
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DNLI May 7, 2024DNLIGeneral
Denali Therapeutics Reports First Quarter 2024 Financial Results and Business Highlights SOUTH SAN FRANCISCO, Calif.
Denali Therapeutics reported its financial results for the first quarter of 2024, showcasing advancements in its clinical portfolio. The company highlighted positive two-year clinical data for its enzyme replacement therapy tividenofusp alfa in MPS II and announced the initiation of a clinical trial for another therapy, DNL126, aimed at MPS IIIA. However, the financial data revealed a net loss of $101.8 million and a lack of collaboration revenue, combined with the discontinuation of specific treatment programs. Despite these challenges, Denali remains optimistic about future opportunities in neurodegenerative disease therapeutics.
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DNLI May 1, 2024DNLIPhases
Denali Therapeutics Announces Completion of Enrollment for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2/3 HEALEY ALS Platform Trial
Denali Therapeutics has announced the successful completion of enrollment for Regimen G in the Phase 2/3 HEALEY ALS Platform Trial, which evaluates its investigational therapy DNL343. The trial seeks to assess the therapeutic effects of this eIF2B agonist, a candidate designed to address mechanisms of neurodegeneration in ALS. While the completion of enrollment is a crucial milestone, the company acknowledges ongoing risks associated with clinical trials and the potential for adverse effects. This latest advancement signifies potential progress in developing effective ALS treatments.
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DNLI Feb 27, 2024DNLIGeneral
▲ +38.2%on this news
Denali Therapeutics Announces $500 million Private Placement Equity Financing
Denali Therapeutics announced a $500 million private placement equity financing aimed at enhancing its product development efforts. This funding will support the research and expansion of its proprietary technology designed to facilitate drug delivery across the blood-brain barrier. The transaction is scheduled to close by February 29, 2024, pending customary conditions. Proceeds from this financing are intended for ongoing research activities and general corporate needs, with expectations of reaching approximately $1.5 billion in cash reserves thereafter.
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DNLI Feb 27, 2024DNLIGeneral
▲ +38.2%on this news
Denali Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights SOUTH SAN FRANCISCO, Calif.
Denali Therapeutics announced its financial results for Q4 and the full year 2023, highlighting significant progress in its portfolio, particularly in late-stage trials for MPS II and ALS. They reported net losses of $119.5 million for the quarter, up from $98.7 million a year earlier. A PIPE financing effort has raised around $500 million, expected to sustain operations through 2028. Despite challenges such as the underperformance of the HIMALAYA study, Denali continues to advance its innovative therapies targeting neurodegenerative diseases.
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DNLI Feb 7, 2024DNLIPhases
Denali Therapeutics Announces New Data and Expansion of Its Blood-Brain Barrier (BBB)-Crossing Enzyme Replacement Therapy Programs at WORLDSymposium™
Denali Therapeutics announced promising new data at the WORLDSymposium™ regarding their enzyme replacement therapies targeting mucopolysaccharidoses. Notable findings include substantial clinical improvements in patients with MPS II after 104 weeks of tividenofusp alfa treatment and progress in the initiation of Phase 1/2 dosing for DNL126 targeting MPS IIIA. The data highlighted sustained reductions in biomarkers and suggestions of cognitive improvements in mouse models, showcasing the potential impacts of Denali’s therapies on both brain and physical symptoms. The company aims for rapid development and collaboration with the MPS community to expedite treatment access.
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DNLI Feb 1, 2024DNLIConferences/Events
Denali Therapeutics Announces Presentations on Its Investigational Blood-Brain Barrier (BBB)-Crossing Enzyme Replacement Therapies at the Upcoming 2024 WORLDSymposium™
Denali Therapeutics announced it will present data on its investigational enzyme replacement therapies, DNL310 and DNL126, at the upcoming 2024 WORLDSymposium™. The presentations will showcase new two-year clinical outcomes for DNL310 and preclinical studies for DNL126. These therapies are designed to cross the blood-brain barrier, addressing symptoms of neurodegenerative diseases and lysosomal storage disorders. The symposium will take place from February 4-9, 2024, in San Diego, California.
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DNLI Jan 8, 2024DNLIPhases
▲ +5.3%on this news
Denali Therapeutics Announces Key Anticipated 2024 Milestones and Priorities to Further Advance Its Therapeutics Portfolio for Neurodegeneration and Lysosomal Storage Diseases Complete enrollment in Denali-led, late-stag
Denali Therapeutics has announced significant progress and anticipated milestones for 2024, focusing on their therapeutic portfolio targeting neurodegenerative and lysosomal storage diseases. Key developments include the completion of enrollment in late-stage clinical trials for MPS II and ALS, as well as the initiation of several new programs utilizing their Enzyme Transport Vehicle technology. Despite positive clinical outcomes, there has been a temporary pause in the DNL593 study due to infusion-related reactions in participants. Overall, Denali aims to maintain momentum in advancing its innovative therapies.
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DNLI Nov 7, 2023DNLIGeneral
Denali Therapeutics Reports Third Quarter 2023 Financial Results and Business Highlights SOUTH SAN FRANCISCO, Calif.
Denali Therapeutics reported its third quarter financial results, highlighting advancements in its therapeutic portfolio for neurodegenerative and lysosomal storage diseases. The company noted promising interim data for DNL310 in MPS II, showing positive biomarker outcomes and good tolerability. Despite these advancements, Denali faced a net loss of $99.4 million, with collaboration revenues decreasing from the previous year. The company is also adjusting its 2023 operating expense guidance downward amid ongoing clinical developments.
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DNLI Aug 30, 2023DNLIPhases
Denali Therapeutics Announces New Interim Data from Phase 1/2 Study of DNL310 (ETV:IDS) in MPS II (Hunter Syndrome) at SSIEM 2023
Denali Therapeutics revealed promising interim data from its Phase 1/2 study of DNL310 for MPS II (Hunter syndrome) at the SSIEM Annual Symposium 2023. The data showcased normalization of key biomarkers and improvements in cognitive functions over a two-year period. DNL310 is a novel enzyme replacement therapy engineered to penetrate the blood-brain barrier, addressing both physical and neurocognitive symptoms of MPS II. The ongoing recruitment for the Phase 2/3 COMPASS study aims to further assess DNL310's efficacy and potential in treating this genetic disorder.
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DNLI Aug 8, 2023DNLIGeneral
Denali Therapeutics Reports Second Quarter 2023 Financial Results and Business Highlights SOUTH SAN FRANCISCO, Calif.
Denali Therapeutics reported its financial results for Q2 2023, highlighting significant advancements in several clinical programs, particularly DNL310 for MPS II. The company demonstrated promising data with a considerable decline in neurofilament light levels, supporting ongoing studies. Additionally, Denali and Biogen progressed in their partnership, though they decided to discontinue the development of TAK-920 DNL919 for Alzheimer's disease. Despite the setbacks in certain areas, Denali aims to optimize its resources and focus on late-stage programs.
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DNLI Jun 20, 2023DNLIPhases
Denali Therapeutics Announces Robust Reduction in Neurofilament Light (NfL) with DNL310 (ETV IDS) Treatment in MPS II (Hunter Syndrome) Interim results demonstrate average reduction of 64% (p 0.001) from baseline in seru
Denali Therapeutics has released promising interim results from its Phase 1/2 study of DNL310, showing a 64% reduction in neurofilament light (NfL) levels in participants with MPS II after two years of dosing. The FDA has endorsed the assessment of NfL as a potential biomarker for understanding the disease's progression and treatment response. Additional data is expected to be presented at the upcoming SSIEM symposium. DNL310 is an investigational therapy aimed at addressing both cognitive and physical symptoms linked to MPS II.
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DNLI May 8, 2023DNLIGeneral
Denali Therapeutics Reports First Quarter 2023 Financial Results and Business Highlights
Denali Therapeutics Inc. reported its financial results for Q1 2023 and provided updates on its clinical programs. The company highlighted advancements in several late-stage therapies, including positive interim data for DNL310 in treating MPS II, which showed beneficial changes in cognitive and behavioral outcomes. Furthermore, Denali presented promising safety and biomarker data for the DNL343 study in ALS and highlighted ongoing recruitment for various other clinical trials. Overall, the updates reflect a strong momentum in Denali's efforts to address neurodegenerative diseases.
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DNLI Apr 10, 2023DNLIPhases
Denali Therapeutics Announces New DNL343 (eIF2B Agonist) Phase 1b Data in ALS To Be Presented at the Upcoming AAN Annual Meeting
Data show that DNL343 is generally well-tolerated at doses that demonstrate robust inhibition of biomarkers associated with the integrated stress response (ISR)
Clinical pharmacokinetic and ISR pharmacodynamic data, along with preclinical data, are consistent with extensive CNS
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DNLI Feb 27, 2023DNLIGeneral
Denali Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Business Highlights
Denali Therapeutics Inc. reported its fourth quarter and full year 2022 financial results, highlighting significant progress in late-stage clinical development for various neurodegenerative and lysosomal storage diseases. The company's Therapeutic portfolio has expanded, with promising interim data from studies on investigational therapies like DNL310 for MPS II and DNL593 for FTD-GRN. Denali’s financial position remains strong, with $1.34 billion in cash and equivalents at the end of 2022, supporting its ongoing research efforts and clinical trials.
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DNLI Feb 22, 2023DNLIPhases
Denali Therapeutics Announces New Interim Data from DNL310 Phase 1/2 Study for MPS II and DNL126 Preclinical Data for MPS IIIA at WORLDSymposium™
Over 49 weeks of DNL310 (ETV:IDS) treatment in the Phase 1/2 study, positive changes across measures of exploratory clinical outcomes including VABS-II (adaptive behavior) and BSID-III (cognitive capabilities) scores and global impression scales were observed
Interim Phase 1/2 d
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DNLI Feb 15, 2023DNLIConferences/Events
Denali Therapeutics Announces Presentations on Enzyme Transport Vehicle (ETV) Development Programs for MPS Diseases at the Upcoming WORLDSymposium™
SOUTH SAN FRANCISCO, Calif., Feb. 15, 2023 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier for the treatment of neurodegenerative diseases and l
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DNLI Jan 25, 2023DNLIPhases
Denali Therapeutics Announces Achievement of RIPK1 Milestone for Phase 2 Clinical Trial Initiation in Multiple Sclerosis by Sanofi
Partner Sanofi has commenced dosing in a Phase 2 clinical trial of SAR443820 (DNL788) in individuals with multiple sclerosis
Denali to receive a milestone payment of $25 million from Sanofi for Phase 2 clinical trial initiation
Development of RIPK1 inhibitor program continues i
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DNLI Jan 9, 2023DNLIPhases
Denali Therapeutics Announces Key Anticipated 2023 Milestones for Its Therapeutic Portfolio for Neurodegeneration and Lysosomal Storage Diseases Four programs expected to progress in late-stage clinical studies for MPS I
Denali Therapeutics has outlined its key milestones for 2023, highlighting the anticipated progression of four therapeutic programs into late-stage clinical studies, targeting MPS II, ALS, and Parkinson's disease. The company is leveraging its proprietary Transport Vehicle technology to enhance drug delivery across the blood-brain barrier. Additional developments in Denali's early-stage pipeline are also underway, with expected interim data readouts from ongoing studies planned throughout the year. CEO Ryan Watts emphasized the company's commitment to address significant unmet needs in neurodegenerative and lysosomal storage diseases with their innovative programs.
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DNLI Dec 5, 2022DNLIPhases
▼ -5.2%on this news
Denali Therapeutics Announces DNL343 Interim Phase 1b Data in ALS and Entry into the HEALEY ALS Platform Trial
DNL343 demonstrated extensive blood-brain barrier penetration and robustly inhibited the integrated stress response pathway implicated in ALS
Once-daily oral dosing with DNL343 for 28 days was generally well tolerated in participants with ALS
The design phase for entry of DNL34
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DNLI Nov 3, 2022DNLIGeneral
Denali Therapeutics Reports Third Quarter 2022 Financial Results and Business Highlights
Denali Therapeutics Reports Third Quarter 2022 Financial Results and Business Highlights
SOUTH SAN FRANCISCO - November 3, 2022 - Denali Therapeutics Inc. (Nasdaq DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-
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DNLI Nov 1, 2022DNLIPhases
Denali Therapeutics Announces Phase 1/2 Study Single Dose Healthy Volunteer Data with TAK-594/DNL593 (PTV:PGRN) and Progression to Enrolling Participants with FTD-GRN
Interim results from Part A in healthy volunteers demonstrated dose-dependent increases in CSF progranulin levels, consistent with robust brain delivery of DNL593
Single doses of DNL593 were generally well tolerated
Data support progression to enrolling participants with FTD-GR
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DNLI Oct 24, 2022DNLIGeneral
Denali Therapeutics Announces Closing of a $316 Million Public Offering, Including Full Exercise of Underwriters’ Option to Purchase Additional Shares
SOUTH SAN FRANCISCO, Calif., Oct. 24, 2022 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI) today announced the closing of its upsized underwritten public offering of 11,933,962 shares of its common stock at a price to the public of $26.50 per share, which includes the
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DNLI Oct 19, 2022DNLIGeneral
▼ -15.1%on this newsshared move
Denali Therapeutics Announces Pricing of $275 Million Public Offering of Common Stock
Denali Therapeutics Announces Pricing of $275 Million Public Offering of Common Stock
SOUTH SAN FRANCISCO, CA - Oct. 19, 2022 - Denali Therapeutics Inc. (NASDAQ DNLI) today announced the pricing of its underwritten public offering of 10,377,359 shares of its common stock at a pr
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DNLI Oct 18, 2022DNLIGeneral
Denali Therapeutics Announces Proposed Offering of Common Stock
Denali Therapeutics Announces Proposed Offering of Common Stock
SOUTH SAN FRANCISCO, Calif. - Oct. 18, 2022 - Denali Therapeutics Inc. (NASDAQ DNLI) today announced that it intends to offer and sell $250 million of shares of its common stock in an underwritten public offering. I
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DNLI Aug 31, 2022DNLIPhases
Denali Therapeutics Announces New Interim Data from Phase 1/2 Study of DNL310 (ETV:IDS) in MPS II (Hunter Syndrome) at SSIEM 2022
Additional one-year data continue to show rapid and sustained normalization to healthy levels of CSF heparan sulfate and improvements in biomarkers of lysosomal function consistent with durable central nervous system activity
Safety profile, now with up to 85 weeks of dosing, co
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DNLI Aug 8, 2022DNLIGeneral
Denali Therapeutics Reports Second Quarter 2022 Financial Results and Business Highlights
Denali Therapeutics Reports Second Quarter 2022 Financial Results and Business Highlights
SOUTH SAN FRANCISCO - August 8, 2022 - Denali Therapeutics Inc. (Nasdaq DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-b
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DNLI May 31, 2022DNLIPhases
Denali Therapeutics and Biogen Announce Initiation of Phase 2b Study of LRRK2 Inhibitor in Parkinson’s Disease
BIIB122 is an inhibitor of LRRK2, a potential novel target intended to impact the underlying biology and slow the progression of Parkinson’s disease
Phase 2b LUMA to enroll approximately 640 participants with early-stage Parkinson’s disease; most advanced clinical study of a LRR
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DNLI May 5, 2022DNLIGeneral
▼ -10.3%on this news
Denali Therapeutics Reports First Quarter 2022 Financial Results and Business Highlights
Denali Therapeutics Reports First Quarter 2022 Financial Results and Business Highlights
SOUTH SAN FRANCISCO - May 5, 2022 - Denali Therapeutics Inc. (Nasdaq DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain
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DNLI May 2, 2022DNLIPhases
▲ +5.7%on this newsshared move
Denali Therapeutics Announces Achievement of RIPK1 Milestone for Phase 2 Clinical Trial Initiation in ALS by Sanofi
Partner Sanofi has commenced dosing in a Phase 2 clinical trial of SAR443820 (DNL788) in individuals with amyotrophic lateral sclerosis (ALS)
Denali to receive a milestone payment of $40 million from Sanofi for Phase 2 clinical trial initiation
Development of RIPK1 inhibitor pr
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DNLI Mar 15, 2022DNLIGeneral
Denali Therapeutics Appoints Alexander Schuth as Chief Operating and Financial Officer as Steve Krognes Transitions to Denali Board of Directors
Denali Therapeutics Appoints Alexander Schuth as Chief Operating and Financial
Officer as Steve Krognes Transitions to Denali Board of Directors
SOUTH SAN FRANCISCO, Calif., March 15, 2022 Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a
broad
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DNLI Mar 9, 2022DNLIPhases
▲ +8.2%on this news
Denali Therapeutics Announces Initiation of Phase 1/2 Clinical Trial of DNL593 (PTV:PGRN) for Frontotemporal Dementia-Granulin (FTD-GRN)
SOUTH SAN FRANCISCO, Calif., March 09, 2022 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announce
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DNLI Feb 28, 2022DNLIGeneral
Denali Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Business Highlights
Denali Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Business Highlights
SOUTH SAN FRANCISCO - February 28, 2022 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to
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DNLI Feb 10, 2022DNLIPhases
▼ -5.4%on this news
Denali Therapeutics Announces Continued Progress in DNL310 (ETV IDS) Program for MPS II (Hunter Syndrome) Supporting Planned Initiation of Phase 2 3 Clinical Trial Longer-term data in 20 patients show sustained normaliza
Denali Therapeutics Announces Continued Progress in DNL310 (ETV IDS) Program for MPS II (Hunter Syndrome) Supporting Planned Initiation of Phase 2 3 Clinical Trial
Longer-term data in 20 patients show sustained normalization to healthy levels of CSF heparan sulfate and improveme
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DNLI Feb 7, 2022DNLIGeneral
▲ +6.2%on this newsshared move
Denali Therapeutics Announces Appointment of Erik Harris to Board of Directors
Denali Therapeutics Announces Appointment of Erik Harris to Board of Directors
SOUTH SAN FRANCISCO, Calif., February 7, 2022 -- Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-br
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DNLI Feb 1, 2022DNLIConferences/Events
Denali Therapeutics Announces Presentations on DNL310 (ETV:IDS) Development Program in MPS II (Hunter Syndrome) at the Upcoming WORLDSymposium™
SOUTH SAN FRANCISCO, Calif., Feb. 01, 2022 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced
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DNLI Jan 13, 2022DNLIFDA Updates
▼ -12.2%on this news
Denali Therapeutics Announces FDA Clinical Hold on DNL919 Investigational New Drug (IND) Application
SOUTH SAN FRANCISCO, Calif., Jan. 13, 2022 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced
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DNLI Jan 10, 2022DNLIPhases
Denali Therapeutics Announces Progression and Expansion of Broad Therapeutic Portfolio for Neurodegeneration and Expected Key Milestones in 2022 Key data readouts to include additional Phase 1 2 data on DNL310 (ETV IDS)
Denali Therapeutics Announces Progression and Expansion of Broad Therapeutic Portfolio for Neurodegeneration and Expected Key Milestones in 2022
Key data readouts to include additional Phase 1 2 data on DNL310 (ETV IDS) in MPS II (Hunter syndrome) and the first clinical data on
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DNLI Nov 17, 2021DNLIGeneral
Denali Therapeutics Announces Strategic Partner Takeda Exercises Option to Co-Develop and Co-Commercialize DNL593 (PTV PGRN) - Companies to advance clinical development of DNL593 as a brain-penetrant progranulin replacem
Denali Therapeutics Announces Strategic Partner Takeda Exercises Option to Co-Develop and Co-Commercialize DNL593 (PTV PGRN)
- Companies to advance clinical development of DNL593 as a brain-penetrant progranulin replacement therapy for frontotemporal dementia-granulin (FTD-GRN)
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DNLI Nov 4, 2021DNLIGeneral
Denali Therapeutics Reports Third Quarter 2021 Financial Results and Business Highlights
Denali Therapeutics Reports Third Quarter 2021 Financial Results and Business Highlights
SOUTH SAN FRANCISCO - November 4, 2021 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-
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DNLI Oct 6, 2021DNLIGeneral
Denali Therapeutics Announces Positive Clinical Results and Regulatory Progress for Development Programs in Amyotrophic Lateral Sclerosis (ALS)
eIF2B activator DNL343 achieved safety and biomarker goals in a Phase 1 study in healthy volunteers; a Phase 1b study began in individuals with ALS in Q3 2021
Fast Track designation granted by the U.S. Food and Drug Administration (FDA) to SAR443820/DNL788, a RIPK1 inhibitor, fo
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DNLI Sep 29, 2021DNLIConferences/Events
Denali Therapeutics Announces Upcoming Presentations on EIF2B Activator DNL343 and RIPK1 Inhibitor SAR443820/DNL788 at the 2021 Annual Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting
Denali to present results from Phase 1 healthy volunteer study of EIF2B activator DNL343
Sanofi to present Phase 2 study plans in ALS for RIPK1 inhibitor SAR443820
Denali to host analyst and investor webinar on October 6, at 4:30 p.m. Eastern Time
SOUTH SAN FRANCISCO, Calif.,
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DNLI Sep 27, 2021DNLIGeneral
Denali Therapeutics Appoints Katie Peng as Chief Commercial Officer
SOUTH SAN FRANCISCO, Calif., Sept. 27, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announce
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DNLI Sep 9, 2021DNLIPhases
Denali Therapeutics Announces Initiation of Phase 1b Study of EIF2B Activator DNL343 in ALS
SOUTH SAN FRANCISCO, Calif., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announce
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DNLI Aug 26, 2021DNLIGeneral
Denali Therapeutics Announces Publication in Cell on New Approach to Treat FTD-GRN
SOUTH SAN FRANCISCO, Calif., Aug. 26, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced
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DNLI Aug 4, 2021DNLIGeneral
Denali Therapeutics Reports Second Quarter 2021 Financial Results and Business Highlights
Denali Therapeutics Reports Second Quarter 2021 Financial Results and Business Highlights
SOUTH SAN FRANCISCO - August 4, 2021 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-b
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DNLI Jul 25, 2021DNLIPhases
▼ -15.3%on this news
Denali Therapeutics Announces Positive Interim Data from Phase 1 2 Study with ETV IDS (DNL310) in Patients with the Lysosomal Storage Disease Hunter Syndrome (MPS II) Rapid reduction and sustained normalization of hepara
Denali Therapeutics Announces Positive Interim Data from Phase 1 2 Study with ETV IDS (DNL310) in Patients with the Lysosomal Storage Disease Hunter Syndrome (MPS II)
Rapid reduction and sustained normalization of heparan sulfate in CSF demonstrated robust and durable CNS activi
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DNLI Jul 15, 2021DNLIPhases
Denali Therapeutics to Present Interim Data from Phase 1/2 Study of ETV:IDS (DNL310) for the Potential Treatment of Hunter Syndrome at MPS 2021
SOUTH SAN FRANCISCO, Calif., July 15, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced
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DNLI Jun 28, 2021DNLIPhases
Denali Therapeutics Announces Initiation of Phase 2 Study by Partner Sanofi of RIPK1-Inhibitor DNL758 (SAR443122) in Cutaneous Lupus Erythematosus (CLE) Patients
SOUTH SAN FRANCISCO, Calif., June 28, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced
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DNLI May 3, 2021DNLIGeneral
Denali Therapeutics Reports First Quarter 2021 Financial Results and Business Highlights
Denali Therapeutics Reports First Quarter 2021 Financial Results and Business Highlights
SOUTH SAN FRANCISCO - May 3, 2021 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain
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DNLI May 1, 2021DNLIPhases
Denali Therapeutics Presents Positive Results from Phase 1 and Phase 1b Studies of Its LRRK2 Inhibitor, BIIB122/DNL151, Supporting Late-Stage Development Plans in Parkinson’s Disease
Treatment with BIIB122/DNL151 achieved robust reductions in biomarkers of target engagement and pathway engagement in healthy volunteers and patients with Parkinson’s disease
BIIB122/DNL151 demonstrated a safety profile supporting continued development in patients with Parkinson
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DNLI Mar 11, 2021DNLIFDA Updates
Denali Therapeutics Announces Fast Track Designation Granted by the U.S. FDA to ETV:IDS (DNL310) for the Treatment of Patients with Hunter Syndrome (MPS II)
SOUTH SAN FRANCISCO, Calif., March 11, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announce
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DNLI Feb 25, 2021DNLIGeneral
Denali Therapeutics Reports Full Year 2020 Financial Results and Business Highlights
Denali Therapeutics Reports Full Year 2020 Financial Results and Business Highlights
SOUTH SAN FRANCISCO - February 25, 2021 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-bra
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DNLI Feb 12, 2021DNLIPhases
Denali Therapeutics Reports Positive Three-Month Data from Phase 1 2 Study with ETV IDS (DNL310) in Patients with Hunter Syndrome (MPS II) Sustained normalization and further decreased levels of CSF glycosaminoglycan hep
Denali Therapeutics Reports Positive Three-Month Data from Phase 1 2 Study with ETV IDS (DNL310) in Patients with Hunter Syndrome (MPS II)
Sustained normalization and further decreased levels of CSF glycosaminoglycan heparan sulfate, a key CNS disease biomarker, observed after t
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DNLI Feb 5, 2021DNLIGeneral
IN THE COURT OF CHANCERY OF THE STATE OF DELAWARE JOHN SOLAK, derivatively on behalf of DENALI THERAPEUTICS, INC., Plaintiff, v. VICKI L. SATO, Ph.D., RYAN J. WATTS, Ph.D., DOUGLAS G. COLE, M.D., JENNIFER COOK, JAY FLATL
IN THE COURT OF CHANCERY OF THE STATE OF DELAWARE
NOTICE OF PENDENCY OF SETTLEMENT OF ACTION
TO: ALL CURRENT STOCKHOLDERS OF DENALI THERAPEUTICS INC.
(TRADING SYMBOL: DNLI)
THIS NOTICE CAREFULLY AND IN ITS ENTIRETY. YOUR RIGHTS WILL BE AFFECTED BY THE LEGAL PROCEEDINGS IN THI
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DNLI Feb 5, 2021DNLIConferences/Events
Denali Therapeutics to Present New Data on ETV:IDS (DNL310) for the Potential Treatment of Hunter Syndrome at WORLDSymposium™
SOUTH SAN FRANCISCO, Calif., Feb. 05, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced
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DNLI Jan 11, 2021DNLIGeneral
Denali Therapeutics Announces Appointment of Nancy Thornberry to Board of Directors
Denali Therapeutics Announces Appointment of Nancy Thornberry to Board of Directors
SOUTH SAN FRANCISCO, Calif., January 11, 2021 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the bloo
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DNLI Jan 8, 2021DNLIGeneral
Denali Therapeutics Announces Significant Program Progress and Expected Key Milestones in 2021 for Its Broad Therapeutic Portfolio in Neurodegeneration
Late-breaker presentation on 12-week data from Cohort A in Phase 1/2 study of DNL310 (ETV:IDS) in Hunter syndrome (MPS II) to be held at WORLD Symposium on February 12th
Following previously announced data on CSF GAG reduction with DNL310 and achievement of biomarker proof-of-co
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DNLI Nov 10, 2020DNLIPhases
Denali Therapeutics Announces First Human Biomarker Proof of Concept for Its Transport Vehicle (TV) Technology Achieved in Phase 1 2 Study of ETV IDS (DNL310) in Hunter Syndrome (MPS II) After four weekly intravenous dos
Denali Therapeutics Announces First Human Biomarker Proof of Concept for Its Transport Vehicle (TV) Technology Achieved in Phase 1 2 Study of ETV IDS (DNL310) in Hunter Syndrome (MPS II)
After four weekly intravenous doses of DNL310, a 76% mean reduction in CSF GAG levels (hepar
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DNLI Nov 5, 2020DNLIGeneral
Denali Therapeutics Reports Third Quarter 2020 Financial Results and Business Highlights
Denali Therapeutics Reports Third Quarter 2020 Financial Results and Business Highlights
SOUTH SAN FRANCISCO - November 5, 2020 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-
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DNLI Oct 15, 2020DNLIConferences/Events
Denali Therapeutics to Highlight Progress Across Broad Biotherapeutics Portfolio for Neurodegeneration Enabled by Its Blood-Brain Barrier (BBB) TV Platform at Virtual R&D Day Today
Proprietary and differentiated Transport Vehicle (TV) technology shows potential to solve the BBB challenge by delivering biotherapeutics to the brain
New preclinical data support the potential for systemic administration of ETV:IDS (DNL310) to treat the neurological pathology o
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DNLI Oct 7, 2020DNLIGeneral
Denali Therapeutics Announces Closing of Collaboration and Share Purchase Agreements with Biogen
Denali Therapeutics Announces Closing of Collaboration and Share Purchase Agreements with Biogen
SOUTH SAN FRANCISCO, Calif., Oct 7, 2020 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross
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DNLI Sep 30, 2020DNLIConferences/Events
Denali Therapeutics to Host Webinar on Transporting Biotherapeutics Across the Blood-Brain Barrier
— Webinar scheduled for Thursday, October 15th at 1:00 p.m. Eastern Time —
SOUTH SAN FRANCISCO, Sept. 30, 2020 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the bloo
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DNLI Aug 7, 2020DNLIGeneral
Denali Therapeutics Reports Second Quarter 2020 Financial Results and Business Highlights
Denali Therapeutics Reports Second Quarter 2020 Financial Results and Business Highlights
SOUTH SAN FRANCISCO - August 7, 2020 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-b
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DNLI Aug 6, 2020DNLIGeneral
Denali Therapeutics Announces Decision to Advance DNL151 into Late Stage Clinical Studies in Parkinson’s Patients
DNL151 selected to advance into two late stage studies in Parkinson’s disease in patients with a kinase activating mutation in LRRK2 and in patients with sporadic disease
Denali and collaboration partner Biogen are finalizing DNL151 clinical development plans and intend to comme
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DNLI Aug 6, 2020DNLIGeneral
BIOGEN AND DENALI TO COLLABORATE ON LRRK2 PROGRAM FOR PARKINSON'S DISEASE AND CERTAIN TV PLATFORM-ENABLED PROGRAMS FOR NEURODEGENERATIVE DISEASES Biogen to receive license to co-develop and co-commercialize Denali's smal
BIOGEN AND DENALI TO COLLABORATE ON LRRK2 PROGRAM FOR PARKINSON'S DISEASE AND CERTAIN TV PLATFORM-ENABLED PROGRAMS FOR NEURODEGENERATIVE DISEASES
Biogen to receive license to co-develop and co-commercialize Denali's small molecule LRRK2 inhibitor program, expanding pipeline of p
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DNLI Jul 29, 2020DNLIPhases
Denali Therapeutics Announces Phase 1b Study by Partner Sanofi of RIPK1-Inhibitor DNL758 (SAR443122) in COVID-19 Patients
Dosing of DNL758 (SAR443122) has commenced in a randomized, double-blind, placebo-controlled Phase 1b trial to evaluate safety and effect on the immune system in severe COVID-19
DNL758, discovered by Denali and partnered with Sanofi, is a small molecule inhibitor of RIPK1 that d
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DNLI Jun 9, 2020DNLIGeneral
Denali Therapeutics Provides Broad Update on Its RIPK1 Program Partnered With Sanofi
Denali and Sanofi pause DNL747(a) clinical activities based on the totality of DNL747 data and a superior profile of backup compound DNL788(b)
Denali and Sanofi intend to accelerate DNL788 for development in neurological indications, with plans to initiate clinical testing by ea
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DNLI May 27, 2020DNLIGeneral
Denali Therapeutics Announces Publication of Two New Papers Describing Its Blood-Brain Barrier Delivery Technology in Science Translational Medicine
Denali’s “Transport Vehicle” technology enables broad distribution and improved exposure levels of therapeutic proteins throughout the brain
Clinical proof of concept data with DNL310 (ETV:IDS), the first product candidate enabled by the transport vehicle technology, are expecte
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DNLI May 7, 2020DNLIGeneral
Denali Therapeutics Reports First Quarter 2020 Financial Results and Provides COVID-19 Response Update
Denali Therapeutics Reports First Quarter 2020 Financial Results and Provides COVID-19 Response Update
SOUTH SAN FRANCISCO - May 7, 2020 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross t
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DNLI Apr 2, 2020DNLIGeneral
DENALI THERAPEUTICS PROVIDES PIPELINE AND BUSINESS UPDATE IN RESPONSE TO THE COVID-19 PANDEMIC SOUTH SAN FRANCISCO
DENALI THERAPEUTICS PROVIDES PIPELINE AND BUSINESS UPDATE IN RESPONSE TO THE COVID-19 PANDEMIC
SOUTH SAN FRANCISCO -- April 2, 2020 -- Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the b
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DNLI Feb 27, 2020DNLIGeneral
Denali Therapeutics Reports Full Year 2019 Financial Results and Business Highlights
Denali Therapeutics Reports Full Year 2019 Financial Results and Business Highlights
SOUTH SAN FRANCISCO - February 27, 2020 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-bra
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DNLI Feb 1, 2020DNLIGeneral
Denali Therapeutics Announces Closing of Public Offering, Including Full Exercise of Underwriters’ Option to Purchase Additional Shares
SOUTH SAN FRANCISCO, Calif., Jan. 31, 2020 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI) today announced the closing of its upsized underwritten public offering of 9,000,000 shares of its common stock at a price to the public of $23.00 per share, which includes the
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DNLI Jan 28, 2020DNLIGeneral
Denali Therapeutics Announces Pricing of Public Offering of Common Stock
Denali Therapeutics Announces Pricing of Public Offering of Common Stock
SOUTH SAN FRANCISCO, CA - Jan. 28, 2020 - Denali Therapeutics Inc. (NASDAQ DNLI) today announced the pricing of its underwritten public offering of 7,826,087 shares of its common stock at a price to the pub
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DNLI Jan 14, 2020DNLIPhases
DENALI THERAPEUTICS ANNOUNCES BROAD PIPELINE PROGRESS INCLUDING POSITIVE RESULTS FROM ITS LRRK2 PROGRAM FOR PARKINSON'S DISEASE LRRK2 inhibitor DNL201 Phase 1b demonstrated high levels of target and pathway engagement an
DENALI THERAPEUTICS ANNOUNCES BROAD PIPELINE PROGRESS INCLUDING POSITIVE RESULTS FROM ITS LRRK2 PROGRAM FOR PARKINSON'S DISEASE
LRRK2 inhibitor DNL201 Phase 1b demonstrated high levels of target and pathway engagement and improvement of lysosomal biomarkers in patients with Park
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DNLI Nov 6, 2019DNLIGeneral
Denali Therapeutics Reports Third Quarter 2019 Financial Results and Business Highlights
Denali Therapeutics Reports Third Quarter 2019 Financial Results and Business Highlights
SOUTH SAN FRANCISCO - November 6, 2019 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases
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DNLI Sep 4, 2019DNLIPhases
Denali Therapeutics Announces First Patient Dosed in Phase 1b Study of DNL151 for Parkinson’s Disease and Launch of Its Engage Parkinson’s Website
Phase 1b study of DNL151 includes Parkinson’s disease patients with and without a genetic LRRK2 mutation
Either DNL151 or DNL201 anticipated to be selected for potential registrational clinical trials in 2020
The Engage Parkinson’s website provides patients, caregivers and othe
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DNLI Aug 6, 2019DNLIGeneral
Denali Therapeutics Reports Second Quarter 2019 Financial Results and Business Highlights
Denali Therapeutics Reports Second Quarter 2019 Financial Results and Business Highlights
SOUTH SAN FRANCISCO - August 6, 2019 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases,
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DNLI Aug 5, 2019DNLIPhases
Denali Therapeutics Announces That Its Partner Sanofi has Commenced Dosing of DNL758 in a Phase 1 Study
Sanofi has commenced dosing of DNL758 in a Phase 1 healthy volunteer study.
DNL758 is an investigational small molecule RIPK1 inhibitor that does not cross the blood-brain barrier, and is intended for peripheral diseases.
Denali will receive a $10 million clinical milestone pay
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DNLI Jun 11, 2019DNLIFDA Updates
Denali Therapeutics Receives Orphan Drug and Rare Pediatric Disease Designation for DNL310, and Expands its Portfolio of Brain Penetrant Enzyme Replacement Programs
DNL310 on track to enter Phase 1/2 clinical study in Hunter Syndrome patients in 2020
DNL310 utilizes Denali’s proprietary blood-brain barrier crossing enzyme transport vehicle (“ETV”) technology
Two additional ETV-enabled enzyme replacement programs were advanced to pre-clinic
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DNLI May 8, 2019DNLIGeneral
Denali Therapeutics Reports First Quarter 2019 Financial Results
Denali Therapeutics Reports First Quarter 2019 Financial Results
SOUTH SAN FRANCISCO - May 8, 2019 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases, today reported financial re
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DNLI Mar 12, 2019DNLIGeneral
Denali Therapeutics Reports Full Year 2018 Financial Results and Business Highlights
Denali Therapeutics Reports Full Year 2018 Financial Results and Business Highlights
SOUTH SAN FRANCISCO - March 12, 2019 - Denali Therapeutics Inc. (NASDAQ DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases, toda
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DNLI Feb 15, 2019DNLIPhases
Denali Therapeutics Announces First Patient Dosed in Phase 1b Study of DNL747 for Alzheimer’s Disease
SOUTH SAN FRANCISCO, Calif., Feb. 15, 2019 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerative diseases, today announced initiation of dosing in a Phase 1b clinical s
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DNLI Jan 8, 2019DNLIPhases
Denali Therapeutics Announces First Patient Dosed in Phase 1b Study of DNL747 for ALS
SOUTH SAN FRANCISCO, Calif., Jan. 08, 2019 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerative diseases, today announced initiation of dosing in a Phase 1b clinical s
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DNLI Dec 10, 2018DNLIPhases
Denali Therapeutics Announces First Patient Dosed in Phase 1b Study of DNL201 for Parkinson’s Disease
Phase 1b study includes Parkinson’s disease patients with and without a genetic LRRK2 mutation
SOUTH SAN FRANCISCO, Calif., Dec. 10, 2018 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates f
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DNLI Nov 19, 2018DNLIPhases
DENALI THERAPEUTICS ANNOUNCES POSITIVE CLINICAL RESULTS WITH ITS LEAD RIPK1 INHIBITOR MOLECULE AND INTENTION TO INITIATE PATIENT STUDIES IN MULTIPLE INDICATIONS IN COLLABORATION WITH SANOFI Phase 1 healthy volunteer stud
DENALI THERAPEUTICS ANNOUNCES POSITIVE CLINICAL RESULTS WITH ITS LEAD RIPK1 INHIBITOR MOLECULE AND INTENTION TO INITIATE PATIENT STUDIES IN MULTIPLE INDICATIONS IN COLLABORATION WITH SANOFI
SOUTH SAN FRANCISCO-November 19, 2018-Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharm
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DNLI Nov 8, 2018DNLIGeneral
Denali Therapeutics Reports Third Quarter 2018 Financial Results and Business Highlights and Announces the Appointment of Jennifer Cook to Board of Directors
Denali Therapeutics Reports Third Quarter 2018 Financial Results and Business Highlights and Announces the Appointment of Jennifer Cook to Board of Directors
SOUTH SAN FRANCISCO - November 8, 2018 - Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing
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DNLI Nov 1, 2018DNLIGeneral
Denali Therapeutics Announces Broad Collaboration with Sanofi to Develop RIPK1 Inhibitors for the Treatment of Neurological and Inflammatory Diseases Candidate RIPK1 inhibitor molecules have the potential to treat Alzhei
Denali Therapeutics Announces Broad Collaboration with Sanofi to Develop RIPK1 Inhibitors for the Treatment of Neurological and Inflammatory Diseases
SOUTH SAN FRANCISCO--November 1, 2018-- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad p
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DNLI Aug 9, 2018DNLIGeneral
Denali Therapeutics Reports Second Quarter 2018 Financial Results
Denali Therapeutics Reports Second Quarter 2018 Financial Results
SOUTH SAN FRANCISCO - August 9, 2018 - Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases, today reported financi
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DNLI Aug 7, 2018DNLIGeneral
Denali Therapeutics Appoints Dana Andersen, Ph.D., as Chief Technical and Manufacturing Officer
SOUTH SAN FRANCISCO, Calif., Aug. 07, 2018 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases, today announced that Dr. Dana Andersen has joined the company as
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DNLI Aug 1, 2018DNLIPhases
DENALI THERAPEUTICS ANNOUNCES POSITIVE CLINICAL RESULTS FROM LRRK2 INHIBITOR PROGRAM FOR PARKINSON'S DISEASE Healthy volunteer study of DNL201 meets all objectives in phase 1 clinical study, including CSF exposure levels
DENALI THERAPEUTICS ANNOUNCES POSITIVE CLINICAL RESULTS FROM LRRK2 INHIBITOR PROGRAM FOR PARKINSON'S DISEASE
SOUTH SAN FRANCISCO - 1 August, 2018 - Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurode
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DNLI May 30, 2018DNLIGeneral
Denali Therapeutics Announces Early Exercise of Its Option to Acquire F-star Gamma
Denali Therapeutics Announces Early Exercise of Its Option to Acquire F-star Gamma
SOUTH SAN FRANCISCO, May 30, 2018 (GLOBE
NEWSWIRE) Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerativ
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DNLI May 11, 2018DNLIGeneral
Denali Therapeutics Reports First Quarter 2018 Financial Results
Denali Therapeutics Reports First Quarter 2018 Financial Results
SOUTH SAN FRANCISCO, Calif., May 11,
2018 Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerative diseases, today reported
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DNLI Mar 19, 2018DNLIPhases
Denali Therapeutics Announces First-In-Human Dosing Of Its RIPK1 Inhibitor Clinical Program And The Appointment Of Peter Klein To Board Of Directors; Reports Fourth Quarter And Full Year 2017 Financial Results And Busine
Denali Therapeutics Announces First-In-Human Dosing Of Its RIPK1 Inhibitor Clinical Program And The Appointment Of Peter
Klein To Board Of Directors; Reports Fourth Quarter And Full Year 2017 Financial Results And Business Highlights
SOUTH SAN FRANCISCO March 19, 2018 Denali Th
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DNLI Feb 8, 2018DNLIGeneral
Denali Therapeutics and Lonza Pharma & Biotech Announce Exclusive Partnership to Develop and Produce Biologic Medicines
Partnership aims to develop drugs for neurodegenerative diseases
Denali will draw on Lonza’s expertise in developing and manufacturing complex biologic molecules
BASEL, Switzerland and SOUTH SAN FRANCISCO, Calif., Feb. 08, 2018 (GLOBE NEWSWIRE) -- Lonza Pharma & Biotech and Den
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DNLI Jan 5, 2018DNLIGeneral
Takeda and Denali Therapeutics Collaborate to Develop and Commercialize Therapies for Neurodegenerative Diseases Collaboration includes three named programs for the treatment of Alzheimer s disease and other neurodegener
Takeda and Denali Therapeutics Collaborate to Develop and
Commercialize Therapies for Neurodegenerative Diseases
Collaboration includes three named programs for the treatment of Alzheimer s disease and other neurodegenerative diseases, utilizing
Denali s Antibody Transport Veh
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DNLI Dec 20, 2017DNLIGeneral
Denali Therapeutics Announces Advancement and Expansion of Its LRRK2 Inhibitor Clinical Program for Parkinson’s Disease
SOUTH SAN FRANCISCO, Calif., Dec. 20, 2017 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerative diseases, today announced that its small molecule inhibitor of leucine-r
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DNLI Dec 12, 2017DNLIGeneral
Denali Therapeutics Announces Closing of Initial Public Offering, Including Full Exercise of Underwriters Option to Purchase Additional Shares
Denali Therapeutics Announces Closing of Initial Public Offering, Including Full
Exercise of Underwriters Option to Purchase Additional Shares
SOUTH SAN FRANCISCO, CA December 12, 2017 Denali Therapeutics Inc. (NASDAQ: DNLI) today announced the closing of its initial public off
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DNLI Dec 8, 2017DNLIGeneral
Denali Therapeutics Inc. (Nasdaq: DNLI) to Ring The Nasdaq Stock Market Opening Bell in Celebration of Its IPO
ADVISORY, Dec. 08, 2017 (GLOBE NEWSWIRE) --
Denali Therapeutics Inc. (Nasdaq:DNLI), a biotechnology company focused on the discovery and development of therapies for patients with neurodegenerative disease, will visit the Nasdaq MarketSite in Times Square in celebration of its i
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DNLI Dec 8, 2017DNLIGeneral
Denali Therapeutics Announces Pricing of Initial Public Offering
SOUTH SAN FRANCISCO, Calif., Dec. 07, 2017 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced the pricing of its initial public offering of 13,888,888 shares of its common stock at a price to the public of $18.00 per share. In addition, the underwriters ha
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