Welcome to our dedicated page for Denali Therapeut news (Ticker: DNLI), a resource for investors and traders seeking the latest updates and insights on Denali Therapeut stock.
Denali Therapeutics Inc. (NASDAQ: DNLI) is a biotechnology and biopharmaceutical company developing product candidates engineered to cross the blood-brain barrier for the treatment of neurodegenerative diseases, lysosomal storage diseases and other serious conditions. This news page aggregates company-reported updates, press releases and related market announcements about Denali’s programs and corporate activities.
Readers can find coverage of Denali’s investigational enzyme replacement therapy tividenofusp alfa (DNL310) for Hunter syndrome (MPS II), including milestones related to its Biologics License Application, Priority Review status and the ongoing Phase 2/3 COMPASS study. News items also describe clinical and regulatory progress for other TransportVehicle™-enabled programs such as DNL126 (ETV:SGSH) for Sanfilippo syndrome type A, DNL952 (ETV:GAA) for Pompe disease, and TV-enabled antibody and oligonucleotide programs for Alzheimer’s and Parkinson’s disease.
In addition to pipeline updates, Denali’s releases discuss collaborations with partners such as Biogen, Takeda and Sanofi, a royalty funding agreement with Royalty Pharma tied to future net sales of tividenofusp alfa, and financial results reflecting research and development spending and launch preparations. Corporate governance and leadership changes, board appointments and participation in healthcare and investor conferences are also reported.
Investors and followers of DNLI can use this page to review historical and recent announcements on clinical trial progress, regulatory interactions, financing transactions and strategic partnerships as disclosed by the company in its public communications.
Denali Therapeutics (Nasdaq: DNLI) reported fourth quarter and full year 2025 results and program updates on Feb 26, 2026. Key items include commercial launch readiness for tividenofusp alfa ahead of an April 5, 2026 PDUFA date and clinical progress across multiple TransportVehicle platform programs.
Other highlights: preliminary Phase 1/2 DNL126 data support an accelerated approval path, IND/CTA clearances and start-up for DNL952 and DNL628, a $275.0 million synthetic royalty deal with Royalty Pharma, a ~ $200.0 million net public offering, and cash and marketable securities of approximately $966.2 million as of Dec 31, 2025.
Denali Therapeutics (NASDAQ: DNLI) presented clinical and preclinical data across three lysosomal storage disorder programs highlighting Enzyme TransportVehicle (ETV) delivery to brain and body. Key points: tividenofusp alfa (DNL310) maintained CSF and urine heparan sulfate reductions through Week 201; DNL126 showed an 80% mean CSF HS reduction at Week 49; DNL952 Phase 1 design and preclinical glycogen reductions in muscle and brain were presented.
Denali Therapeutics (Nasdaq: DNLI) will host a live webcast on Thursday, February 5, 2026 at 12:30 p.m. Pacific Time to review presentations on its Enzyme TransportVehicle™ (ETV) programs delivered at the 22nd Annual WORLDSymposium, held February 2–6, 2026 in San Diego.
The webcast will highlight the ETV approach to enable enzyme replacement therapy delivery across the whole body, including the brain, and is accessible via the Events page of Denali’s investor website.
Denali Therapeutics (Nasdaq: DNLI) will present clinical and preclinical data for its Enzyme TransportVehicle (ETV) programs at the 22nd Annual WORLDSymposium, Feb 2-6, 2026. Highlights include Phase 1/2 follow-up for tividenofusp alfa (DNL310), preliminary Phase 1/2 DNL126 data, and a Phase 1 design for DNL952.
The U.S. FDA is conducting Priority Review of the tividenofusp alfa BLA with a decision expected by April 5, 2026. Multiple posters and two oral presentations will cover clinical outcomes, quality-of-life surveys, a sibling case study, and preclinical Pompe data.
Denali Therapeutics (NASDAQ: DNLI) outlined 2026 priorities focused on commercial launch preparation for tividenofusp alfa for Hunter syndrome, with a PDUFA target date of April 5, 2026. The company highlighted multiple anticipated clinical readouts and study initiations across TV-enabled and small-molecule programs, including Phase 1b start for DNL628 (OTV:MAPT) and Phase 1 start for DNL952 (ETV:GAA).
Recent milestones include a NEJM publication of tividenofusp data, completion of key enrollments, FDA lift of the clinical hold for DNL952, ~$872.9M cash as of Sept 30, 2025, a ~$200M equity financing, and a royalty funding agreement up to $275M.
Denali Therapeutics (Nasdaq: DNLI) announced Phase 1/2 results for tividenofusp alfa (DNL310) in Hunter syndrome published in The New England Journal of Medicine and supporting a FDA Priority Review with a PDUFA date of April 5, 2026.
In an open-label study of 47 children (median age 5), tividenofusp alfa produced large reductions in disease biomarkers: CSF heparan sulfate −91% at Week 24 (maintained 92% at Week 153; N=16), urine HS −88% at Week 24 (91% at Week 153; N=10), and NfL −21% at Week 49 (76% at Week 153; N=13). Clinical signals included liver volume normalization at 24 weeks, improved hearing thresholds, and gains in adaptive behavior and cognition. Infusion-related reactions were the most common treatment-related adverse events and declined with continued dosing.
Denali Therapeutics (NASDAQ: DNLI) priced an underwritten public offering on Dec 10, 2025 of 9,142,857 common shares at $17.50 per share and issued pre-funded warrants to purchase 2,285,714 shares at $17.49 each.
The company granted underwriters a 30-day option to buy up to 1,714,285 additional shares and expects total gross proceeds of approximately $200 million before fees. The offering is expected to close on or about Dec 11, 2025, subject to customary closing conditions. A Form S-3 was effective Feb 27, 2025, and a preliminary prospectus supplement was filed Dec 9, 2025.
Denali Therapeutics (NASDAQ: DNLI) announced a proposed underwritten public offering to sell $200 million of common stock and, for certain investors, pre-funded warrants to purchase common stock. The company also intends to grant the underwriters a 30-day option to buy up to an additional $30 million of common stock. All securities will be sold by Denali and offered pursuant to an automatically effective Form S-3 registration statement.
The proposed offering is subject to market and other conditions and there is no assurance as to timing, size, or final terms; final terms will be disclosed in a prospectus supplement filed with the SEC.
Denali Therapeutics (NASDAQ: DNLI) and Royalty Pharma (NASDAQ: RPRX) agreed to a $275 million synthetic royalty funding deal tied to future net sales of tividenofusp alfa, Denali’s lead TransportVehicle™ enzyme replacement therapy for MPS II (Hunter syndrome).
An FDA BLA for accelerated approval is under review with a PDUFA target date of April 5, 2026. Royalty Pharma will pay $200 million at closing plus an additional $75 million if tividenofusp alfa receives EMA approval by December 31, 2029. In return Royalty Pharma receives a 9.25% royalty on worldwide net sales, ending at a 3.0x payment multiple (or 2.5x if reached by Q1 2039).
Transaction closing is subject to conditions including U.S. accelerated approval; legal advisors were named for both parties.
Denali Therapeutics (Nasdaq: DNLI) reported Q3 2025 results and program updates on Nov 6, 2025. Key clinical milestones: the FDA extended the PDUFA date for the tividenofusp alfa BLA from Jan 5, 2026 to Apr 5, 2026 after a Major Amendment; enrollment completed in the Phase 1/2 DNL126 study with CSF heparan sulfate reductions; CTAs/IND submitted in October to start trials for DNL628 (Alzheimer’s) and DNL952 (Pompe disease). Corporate: board appointment announced and CMO transition to Acting CMO Peter Chin. Financials: net loss $126.9M for Q3 2025 and cash, cash equivalents, and marketable securities of $872.9M. Investor Day set for Dec 4, 2025.