SOUTH SAN FRANCISCO, Calif., Dec. 30, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced the publication of results from the open-label Phase 1/2 clinical trial of its investigational, next-generation enzyme replacement therapy (ERT), tividenofusp alfa (DNL310), for the treatment of Hunter syndrome (mucopolysaccharidosis type II, or MPS II) in the January 1, 2026 i...
Denali Therapeutics Inc. is maintained at a Strong Buy rating, driven by progress in its MPS II [Hunter Syndrome] program with tividenofusp alfa. Despite discontinuing ALS efforts, DNLI's BLA for tividenofusp alfa is under FDA Priority Review under Accelerated Approval pathway, with PDUFA date extended to April 5, 2026. Company's ETV platform enables expansion into additional lysosomal storage ...
SOUTH SAN FRANCISCO, Calif., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI) today announced the pricing of its underwritten public offering of 9,142,857 shares of its common stock at a price to the public of $17.50 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 2,285,714 shares of common stock at a price of $17.49 per pre-...
SOUTH SAN FRANCISCO, Calif., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI) today announced that it intends to offer and sell $200 million of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock in an underwritten public offering. In addition, Denali Therapeutics intends to grant the u...
SOUTH SAN FRANCISCO, Calif. and NEW YORK, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) and Royalty Pharma plc (Nasdaq: RPRX) today announced a $275 million synthetic royalty funding agreement based on future net sales of tividenofusp alfa.
Denali Therapeutics (DNLI) is transitioning from a clinical-stage to a commercial-stage biotech, leveraging its innovative blood-brain barrier Transport Vehicle platform. DNLI's financials reflect increased investment in manufacturing and commercialization, with sufficient cash runway (~1.5 years) to support upcoming product launches. Tividenofusp Alfa (DNL310) for MPS II is the lead candidate,...
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