Regeneron Pharmaceuticals announced a pivotal Phase 3 trial success for garetosmab, a drug for fibrodysplasia ossificans progressiva (FOP), an ultra-rare condition causing abnormal bone formation. The company plans to seek FDA approval by the end of 2025. FOP involves progressive and debilitating heterotopic ossification triggered by ALK-2 gene mutations. The approval of garetosmab would offer a first-in-class therapeutic option for this life-shortening disease affecting about 1,000 globally.