Denali Therapeutics Inc. (DNLI)

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

NEW YORK and SOUTH SAN FRANCISCO, Calif., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) and Denali Therapeutics, Inc. (Nasdaq: DNLI) today announced a $275 million synthetic royalty funding agreement based on future net sales of tividenofusp alfa.

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.

Edgestream Partners L.P. bought a new position in shares of Denali Therapeutics Inc. (NASDAQ: DNLI) during the undefined quarter, according to the company in its most recent disclosure with the SEC. The fund bought 342,923 shares of the company's stock, valued at approximately $4,797,000. Edgestream Partners L.P. owned about 0.24% of Denali Therapeutics

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, with FDA review delayed to April 2026 but no major clinical concerns cited by regulators.

Creative Planning increased its stake in shares of Denali Therapeutics Inc. (NASDAQ: DNLI) by 88.7% in the second quarter, according to the company in its most recent Form 13F filing with the Securities and Exchange Commission. The firm owned 57,678 shares of the company's stock after purchasing an additional 27,114 shares during the

Denali Therapeutics Inc. (NASDAQ: DNLI - Get Free Report) has been assigned a consensus recommendation of "Buy" from the sixteen ratings firms that are currently covering the stock, MarketBeat.com reports. One analyst has rated the stock with a sell rating, twelve have given a buy rating and three have given a strong buy rating to the

Denali Therapeutics Inc. ( DNLI ) Jefferies London Healthcare Conference 2025 November 18, 2025 7:30 AM EST Company Participants Ryan Watts - Co-Founder, President, CEO & Director Alexander Schuth - Co-Founder, CFO, COO & Secretary Conference Call Participants Lin Tsai - Jefferies LLC, Research Division Presentation Lin Tsai Jefferies LLC, Research Division Okay. We're going to get started with our next session.

Denali's Q3 loss widens year over year as expenses rise, while the FDA delays its review of the firm???s key Hunter syndrome therapy to 2026.

SOUTH SAN FRANCISCO, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the third quarter ended September 30, 2025, and provided business highlights.

The U.S. Food and Drug Administration extended on Monday Denali Therapeutics Inc.'s (NASDAQ:DNLI) review timeline of the Biologics License Application (BLA), seeking accelerated approval of tividenofusp alfa for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome.