Denali Therapeutics

DNLI

Market cap $2.38B

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.

Tividenofusp alfa BLA for Hunter syndrome accepted for priority review and assigned PDUFA target action date of January 5, 2026; company preparing for commercial launch DNL126 accelerated approval path for Sanfilippo syndrome Type A aligned with FDA; Phase 1/2 study nearing completion of enrollment; planning underway for a global Phase 3 confirmatory study On track to submit regulatory applications in 2025 to begin clinical testing of one to two additional TransportVehicleTM (TV)-enabled programs Preclinical research on ATV:Abeta program for Alzheimer's disease published in the journal Science SOUTH SAN FRANCISCO, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the second quarter ended June 30, 2025, and provided business highlights.

Denali's lead drug for Hunter syndrome wins FDA Priority Review, marking a key step toward commercial-stage status.

FDA assigns PDUFA target action date of January 5, 2026, for decision on accelerated approval Tividenofusp alfa is designed to deliver missing enzyme to entire body and cross blood-brain barrier into the brain Tividenofusp alfa leads company's broader TransportVehicle™-enabled pipeline SOUTH SAN FRANCISCO, Calif., July 07, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) seeking accelerated approval for tividenofusp alfa for the treatment of Hunter syndrome (mucopolysaccharidoses type II, or MPS II), a rare and progressive genetic disorder.