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IMCIVREE (setmelanotide)

Updated ยทnext FDA decision on the calendar

IMCIVREE (setmelanotide) 1 FDA decision on record below. Every date links its source.

RYTM catalyst hub

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.