MYSTERIOUS: Denali therapeutics - What They Never Told You

Denali Therapeutics Says AVLAYAH Launch Ahead of Expectations After Hunter Syndrome Approval

Denali Therapeutics (NASDAQ:DNLI) is seeing early commercial interest for its first approved drug, AVLAYAH, following its March 24 accelerated approval for Hunter syndrome, Chief Operating Officer and Chief Financial Officer Alexander Schuth said at a Bank of America Securities conference. Speaking

MarketBeat · May 16

Denali Flags Minimal Delay After FDA Halts Rare Disease Trial Start

The U.S. Food and Drug Administration (FDA) placed a clinical hold on Denali Therapeutics Inc.’s (NASDAQ:DNLI) investigational new drug (IND) application for the Phase 1 study of DNL952 under development for Pompe disease.

Benzinga · Dec 5, 2025

FDA Delays Decision Date For Denali Therapeutics' Lead Drug Candidate

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.

Benzinga · Oct 14, 2025