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pdufa.bio

Setmelanotide

Updated ยทnext FDA decision on the calendar

Setmelanotide is a Rhythm Pharmaceuticals, Inc. program. Its next catalyst is a Readout in Oct 2026. 1 FDA decision on record below. Every date links its source.

RYTM catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Setmelanotide is marketed as IMCIVREE (setmelanotide); the events below include those tracked under the brand name. Sponsor: Rhythm Pharmaceuticals, Inc. (RYTM). We track 2 catalyst events for this program: 1 upcoming and 1 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 · Mar 20, 2026 ✓ ApprovedRYTMReadout · Oct 2026RYTM

Questions

When is Setmelanotide's next FDA decision or readout?

The next tracked catalyst for Setmelanotide is a Readout in Oct 2026.

What happened at Setmelanotide's most recent FDA decision?

On Mar 20, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Who makes Setmelanotide?

Rhythm Pharmaceuticals, Inc. (RYTM).

Has Setmelanotide been approved by the FDA?

Yes. The FDA approved an application for Setmelanotide on Mar 20, 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.