Setmelanotide is a Rhythm Pharmaceuticals, Inc. program. The FDA approved it on Mar 20, 2026. 1 FDA decision on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
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: 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.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| RA Capital Management | 6,666,837 | $740.2 million | filed August 14, 2026 |
| Baker Bros. Advisors | 5,604,483 | $622.3 million | filed August 14, 2026 |
| Perceptive Advisors | 2,586,295 | $287.2 million | filed August 14, 2026 |
| OrbiMed Advisors | 322,900 | $35.9 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
No upcoming catalyst is on our calendar for Setmelanotide; 1 FDA decision is on record below.
On Mar 20, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
Rhythm Pharmaceuticals, Inc. (RYTM).
Yes. The FDA approved an application for Setmelanotide on Mar 20, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.