Denali Therapeut Stock Price, News & Analysis

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.

Notable developments include promising preclinical research on their ATV:Abeta program for Alzheimer's disease, published in Science, demonstrating improved brain distribution and reduced ARIA risk compared to conventional antibody treatments.

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.

Denali Therapeutics (NASDAQ: DNLI) has completed its BLA rolling submission for tividenofusp alfa, targeting Hunter syndrome treatment. The therapy, if approved, would be the first FDA-approved enzyme replacement treatment engineered to cross the blood-brain barrier. The company received Breakthrough Therapy Designation in January 2025 and expects potential commercial launch in late 2025 or early 2026. Key Q1 2025 financials show a net loss of $133.0 million, compared to $101.8 million in Q1 2024. R&D expenses increased to $116.2 million, up from $107.0 million year-over-year. The company maintains a strong cash position of $1.05 billion. Notable developments include the opening of a clinical biomanufacturing facility in Salt Lake City and productive FDA discussions regarding DNL126 for Sanfilippo syndrome Type A. However, their DNL343 program for ALS did not meet its primary endpoint in Phase 2/3 trials.

Denali Therapeutics (NASDAQ: DNLI) has initiated a rolling submission of a biologics license application (BLA) for accelerated approval of tividenofusp alfa to treat Hunter syndrome (MPS II). The submission has been received by the FDA's Center for Drug Evaluation and Research (CDER).

The company reports alignment with CDER on the BLA data package, including using cerebrospinal fluid heparan sulfate as a surrogate endpoint for accelerated approval. Denali expects to complete the BLA submission by first half of May 2025, with potential U.S. commercial launch anticipated in late 2025 or early 2026.

Additionally, Denali continues productive collaboration with CDER through the START program, focusing on an accelerated development and approval path for DNL126, targeting Sanfilippo syndrome treatment.