Denali Therapeutics

DNLI

Market cap $2.85B

Denali Therapeutics Inc. (DNLI) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript

DNLI maps 2026 goals as it awaits FDA action on tividenofusp alfa, targeting first commercial validation amid multiple late-stage readouts.

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 issue of The New England Journal of Medicine. The U.S. Food and Drug Administration (FDA) is conducting a Priority Review of the Biologics License Application (BLA) for tividenofusp alfa, which is supported by these data and for which Denali is seeking accelerated approval. A decision by the FDA on the tividenofusp alfa BLA is expected by April 5, 2026.

Biotech's 2025 rebound sets the stage for Denali Therapeutics and two peers, with key FDA decisions and pipeline catalysts lined up for 2026.

Wednesday brought gains for major stock benchmarks. The Federal Reserve cut interest rates but signaled a slowing in expected future reductions.

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 disorders, with DNL126 for MPS IIIA offering near-term catalysts and proof of platform versatility.

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-funded warrant, which represents the per share public offering price of each share of common stock less the $0.01 per share exercise price for each pre-funded warrant. All of the shares and pre-funded warrants are to be sold by Denali Therapeutics. In addition, Denali Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 1,714,285 shares of its common stock. Denali Therapeutics expects to receive total gross proceeds of approximately $200 million before deducting underwriting discounts and commissions and other offering expenses and excluding any exercise of the underwriters' option to purchase additional shares. The offering is expected to close on or about December 11, 2025, subject to satisfaction of customary closing conditions.

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 underwriters a 30-day option to purchase up to an additional $30 million of shares of common stock. All of the shares of common stock and pre-funded warrants to be sold in the proposed offering will be sold by Denali Therapeutics. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

DNLI secures a $275M funding deal with Royalty Pharma tied to potential approvals for its Hunter syndrome therapy.

Denali Therapeutics Inc. (DNLI) Analyst/Investor Day Transcript