Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for BBP-418 in Limb-Girdle Muscular Dystrophy. The expected timing is based on the latest available company guidance and may change.
03/30/26:- NDA submitted; FORTIFY Phase 3 interim met endpoints; U.S. launch expected late 2026/early 2027. 05/27/26:- NDA accepted for Priority Review; PDUFA set for November 27, 2026.
Verification
Confirm timing and program details against the company announcement or filing.