Denali Therapeut Stock Price, News & Analysis

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.

Denali Therapeutics (NASDAQ: DNLI) announced board and executive leadership changes on November 6, 2025. Tim Van Hauwermeiren, co‑founder and CEO of argenx, was appointed to Denali’s Board of Directors. Carole Ho, M.D., who served as Denali’s Chief Medical Officer and Head of Development since 2015, will depart to join Eli Lilly as Executive Vice President and President of Lilly Neuroscience. Peter Chin, M.D., a neurologist who joined Denali in 2019, will serve as Acting Chief Medical Officer and Head of Development. Dr. Ho will transition responsibilities to Dr. Chin through late November 2025. The announcement notes the company’s recent filing of a Biologics License Application for tividenofusp alfa for Hunter syndrome.

Denali Therapeutics (Nasdaq: DNLI) said the FDA extended the PDUFA target date for its Biologics License Application for tividenofusp alfa to treat mucopolysaccharidosis type II (MPS II/Hunter syndrome) from Jan 5, 2026 to Apr 5, 2026.

The extension follows Denali’s submission of updated clinical pharmacology information and the FDA’s classification of that submission as a Major Amendment, which per FDA rules adds three months to review. Denali stated the amendment was not related to efficacy, safety, or biomarkers and that no additional data were requested. The company said it continues preparing for potential approval and commercial launch.

Denali Therapeutics (NASDAQ:DNLI) reported significant progress in its clinical programs during Q2 2025. The FDA accepted the company's BLA for tividenofusp alfa with priority review for Hunter syndrome, with a PDUFA date of January 5, 2026. The company also reached FDA alignment on an accelerated approval path for DNL126 for Sanfilippo syndrome Type A.

Key financial metrics include a net loss of $124.1 million (vs $99.0 million in Q2 2024), R&D expenses of $102.7 million (up from $91.4 million), and cash reserves of $977.4 million. The company plans to submit regulatory applications for one to two additional TransportVehicle™ (TV)-enabled programs in 2025.

Denali Therapeutics (NASDAQ:DNLI) announced that the FDA has accepted and granted Priority Review for their Biologics License Application (BLA) for tividenofusp alfa, a potential treatment for Hunter syndrome (MPS II). The FDA has set a PDUFA target action date of January 5, 2026.

Tividenofusp alfa represents a significant advancement in enzyme replacement therapy, being the first in nearly 20 years. Using Denali's TransportVehicle™ platform, it's designed to deliver the missing IDS enzyme across the blood-brain barrier, potentially addressing both neurological and physical symptoms of Hunter syndrome. The BLA is supported by data from a Phase 1/2 study involving 47 participants, with ongoing Phase 2/3 COMPASS study for global approvals.