Denali Therapeutics

DNLI

Market cap $2.86B

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.

Denali Therapeutics faces an FDA review delay for its Hunter syndrome drug, pushing potential approval of tividenofusp alfa to April 2026.

SOUTH SAN FRANCISCO, Calif., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that the U.S. Food and Drug Administration (FDA) has extended its 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. The Prescription Drug User Fee Act (PDUFA) target date has been extended from January 5, 2026, to April 5, 2026.

Denali Therapeutics (DNLI) reported earnings 30 days ago. What's next for the stock?

Denali Therapeutics Inc. (NASDAQ:DNLI ) Morgan Stanley 23rd Annual Global Healthcare Conference September 8, 2025 1:05 PM EDT Company Participants Ryan Watts - Co-Founder, President, CEO & Director Conference Call Participants Sean Laaman - Morgan Stanley, Research Division Presentation Sean Laaman Head of Healthcare Research & Equity Analyst Good afternoon, everyone, and welcome to Morgan Stanley Global Healthcare Conference. I'm Sean Laaman, Head of U.S. mid-cap biotech equity research at the firm.

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Denali Therapeutics posts narrower-than-expected Q2 loss. The company advances multiple rare disease therapies toward potential approvals.