Fibrodysplasia Ossificans Progressiva (FOP)
MIRMMirum PharmaceuticalsCatalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Zilurgisertib (ALK2 Inhibitor) in Fibrodysplasia Ossificans Progressiva (FOP). The expected timing is based on the latest available company guidance and may change.
05/06/26:- In-licensed zilurgisertib; NDA accepted for FOP with Priority Review and PDUFA September 26, 2026. 08/05/26:- PROGRESS pivotal Ph2 results presented; PDUFA remains September 26, 2026.
Verification
Confirm timing and program details against the company announcement or filing.