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pdufa.bio

Garetosmab

Updated ยทnext FDA decision on the calendar

Garetosmab is a Regeneron Pharmaceuticals Inc. program in Fibrodysplasia Ossificans Progressiva (FOP). The FDA approved it on Aug 19, 2026. 1 FDA decision on record below. Every date links its source.

REGN catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Garetosmab is marketed as Pasatru (garetosmab-grts); the events below include those tracked under the brand name. Indication under review: Fibrodysplasia Ossificans Progressiva (FOP). Sponsor: Regeneron Pharmaceuticals Inc. (REGN). Market-cap tier at the time we tracked it: Large. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Aug 19, 2026 ✓ ApprovedREGNPDUFA · Aug 31, 2026REGN

Questions

When is Garetosmab's next FDA decision or readout?

No upcoming catalyst is on our calendar for Garetosmab; 1 FDA decision is on record below.

What happened at Garetosmab's most recent FDA decision?

On Aug 19, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

What is Garetosmab used for?

In our records Garetosmab is under review or in development for Fibrodysplasia Ossificans Progressiva (FOP).

Who makes Garetosmab?

Regeneron Pharmaceuticals Inc. (REGN).

Has Garetosmab been approved by the FDA?

Yes. The FDA approved an application for Garetosmab on Aug 19, 2026; the decision page linked above carries the source.

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.