Pasatru (garetosmab-grts) approved on August 19, 2026 - twelve days before its August 31 PDUFA goal date - as the first treatment for fibrodysplasia ossificans progressiva.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (2/26/26) through T+5. Run-up high $810.24 on 8/18/26, low $600.66 on 6/1/26 (T-120 to T-1). FDA decision 8/19/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-08-19
OutcomeApproved
Drug / candidatePasatru (garetosmab-grts)
IndicationFibrodysplasia ossificans progressiva (FOP) in adults - reduction of new heterotopic ossification lesions and clinician-assessed flare-ups
CompanyRegeneron Pharmaceuticals, Inc.
Market-cap tierLarge
120-day run-up (T-120→T-1)+5.1%
Cohort decision-day move (history)1.0% median (n=829)
The PDUFA target action date was August 31, 2026; the FDA approved the BLA on August 19, twelve days early, under Priority Review. Pasatru is a fully human monoclonal antibody blocking Activin A, and the first and only FDA-approved treatment shown in a placebo-controlled trial to reduce both new heterotopic ossification lesions and clinician-assessed flare-ups in adults with FOP, an ultra-rare genetic disorder affecting roughly 900 diagnosed people worldwide. Approval rests on the Phase 3 OPTIMA trial: a 90% reduction in new HO lesions at 56 weeks at the 10 mg/kg dose (94% at 3 mg/kg) versus placebo by CT scan, with an 88% reduction in clinician-assessed flare-ups at the higher dose. Garetosmab previously held Fast Track and Orphan Drug designations. An EMA submission is under review.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Was Pasatru (garetosmab-grts) approved by the FDA?
Yes. The FDA approved the application for Pasatru (garetosmab-grts) on August 19, 2026. The primary source is linked on this page.
Which company is behind Pasatru (garetosmab-grts)?
Pasatru (garetosmab-grts) is a Regeneron Pharmaceuticals, Inc. (REGN) program. The FDA decision came on August 19, 2026; the company's own announcement is linked on this page.
How did REGN stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), REGN moved +5.1%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.
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