FDA Delays Decision Date For Denali Therapeutics' Lead Drug Candidate

benzinga.com/news/fda/25/10/48209369/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…

This story appeared on benzinga.com, 2025-10-14 18:43:36.
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