The FDA has accepted Regeneron's Biologics License Application for garetosmab to treat fibrodysplasia ossificans progressiva, granting Priority Review with a target action date of August 2026. The application is supported by Phase 3 OPTIMA trial data.
The FDA has accepted Regeneron's biologics license application for garetosmab with priority review, targeting fibrodysplasia ossificans progressiva. A decision is expected by August 2026 based on Phase 3 trial data showing significant reductions in new bone lesions.
Regeneron said the FDA accepted its garetosmab BLA for FOP and granted Priority Review, with a decision expected by August 2026. Phase 3 OPTIMA data reported major lesion reductions versus placebo.
The FDA has accepted for Priority Review Regeneron's biologics license application for garetosmab to treat adults with fibrodysplasia ossificans progressiva, with a target action date of August 2026.
The FDA has accepted for Priority Review the Biologics License Application for garetosmab to treat adults with fibrodysplasia ossificans progressiva, with a target decision date of August 2026. The application is supported by Phase 3 OPTIMA trial data showing significant reductions in heterotopic bone lesions.
