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IMCIVREE (setmelanotide)

Updated ยทnext FDA decision on the calendar

IMCIVREE (setmelanotide) The FDA approved it on Mar 20, 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

We track 1 catalyst event for this program: 0 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 ✓ ApprovedRYTM

Questions

When is IMCIVREE (setmelanotide)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for IMCIVREE (setmelanotide); 1 FDA decision is on record below.

What happened at IMCIVREE (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.

Has IMCIVREE (setmelanotide) been approved by the FDA?

Yes. The FDA approved an application for IMCIVREE (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.

Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.
About · Corrections · Methodology

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