News Related to Activin A

Regeneron's Garetosmab Receives FDA Priority Review for Rare Bone Disorder FOP

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.

FDA Grants Priority Review to Regeneron's Garetosmab for Rare Bone Disease FOP

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.

Regeneron’s garetosmab BLA for FOP accepted by FDA with Priority Review

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.

FDA Grants Priority Review to Garetosmab for Rare Bone Disorder Fibrodysplasia Ossificans Progressiva

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.

FDA Accepts Garetosmab BLA for Priority Review in Fibrodysplasia Ossificans Progressiva

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.