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Mar 02, 2026
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.
Mar 02, 2026
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.
Feb 26, 2026
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.
Feb 20, 2026
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.
Feb 19, 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.
