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. • DNLI is in negative territory. Track the latest developments here.The Prescription Drug User Fee Act (PDUFA) target date has been extended from Jan. 5, 2026, to April 5, 2026.Also Read: Denali Therapeutics Ends ...