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AUG 19 2026
UPCOMING · 19 DAYS TO PDUFA

Regeneron Pharmaceuticals garetosmab $REGN

for fibrodysplasia ossificans progressiva (FOP)

BLA · Priority Review · Orphan · Breakthrough

Accepted FEB 19 2026.

About

Fibrodysplasia ossificans progressiva (FOP) is a severely disabling genetic disorder where soft tissues like muscles and tendons progressively turn into bone, locking joints in place. Garetosmab is an antibody designed to block a key protein called activin A, which normally signals the body to form bone. By interfering with this signal, the drug may slow the abnormal bone formation that gradually restricts movement.

Pivotal trial

OPTIMA Phase 3 active not recruiting NCT05394116

This study is researching an experimental drug called garetosmab. The study is focused on adult patients with fibrodysplasia ossificans progressiva (FOP)

Source: ClinicalTrials.gov

Also in development