Catalyst overview
Research summary
This catalyst tracks a Approved update for Garetosmab in Fibrodysplasia Ossificans Progressiva. The expected timing is based on the latest available company guidance and may change.
OPTIMA Trial. 9/17/25- Announced favorable Ph3 results. NDA submission by YE 2025. 02/19/26:- BLA accepted for Priority Review with August 2026 decision; OPTIMA 2 pediatric Ph3 planned. 08/19/26:- FDA approved Pasatru for adult FOP. OPTIMA 2 pediatric Phase 3 planned later 2026.
Verification
Confirm timing and program details against the company announcement or filing.