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AUG 19 2026
APPROVED · 41 DAYS AGO

Regeneron Pharmaceuticals — Pasatru (garetosmab) $REGN

for fibrodysplasia ossificans progressiva (FOP)

BLA · Priority Review · Orphan · Breakthrough

About

Fibrodysplasia ossificans progressiva is an ultra-rare genetic condition that progressively turns muscles, tendons, and ligaments into solid bone, severely restricting movement. Garetosmab is an antibody drug designed to block a protein called activin A, which acts as a central signal in this abnormal bone-forming process. By neutralizing this signal, garetosmab may be able to slow or prevent the formation of new, restrictive bone, potentially helping to preserve mobility for patients.

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