Friday, March 20, 2026
Approved
approved Note: Approved March 19, 2026 for acquired hypothalamic obesity (adults and pediatric ages 4+). PDUFA had been extended 3 months from original date. Based on Phase 3 TRANSCEND trial (-18.4% placebo-adjusted BMI reduction). Source: https://ir.rhythmtx.com/news-releases/news-release-details/rhythm-pharmaceuticals-announces-fda-approval-imcivreer-1/
Drug Information
- Drug Name
- IMCIVREE (setmelanotide) (CT.gov)
- Application Type
- sNDA
- Indication
- Acquired hypothalamic obesity
- Approved As
- IMCIVREE (setmelanotide)
Filing Details
- Company
- Rhythm Pharmaceuticals, Inc. →
- Stock Ticker
- RYTM
- SEC CIK
- 0001649904
- Source
- Company IR →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
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Data sourced from SEC EDGAR filings. Last updated: 2026-03-22. Report an issue