Mirum Pharmaceuticals, Inc.
zilurgisertib
fibrodysplasia ossificans progressiva (FOP)
Countdown
82days
FDA decision · Sep 26, 2026
What's at stake
The FDA's approval decision on zilurgisertib for fibrodysplasia ossificans progressiva (FOP) is due Sep 26, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 8-K
verified 13h ago
“U.S. FDA accepted the New Drug Application (NDA) for zilurgisertib in FOP patients 12 years and older and granted Priority Review with a Prescription Drug User Fee Act (PDUFA) date of September 26, 2026.”