pdufa.bio
HomeDecisions › RYTM 2026-03-20

RYTM FDA decision — Mar 20, 2026

✓ APPROVED

Rhythm Pharmaceuticals Inc. — IMCIVREE (setmelanotide) · Hypothalamic obesity.

Run-up into the decision (T-120 → T+5)

PDUFA 3/20/26$117.62$85.8610/3/25
Daily close, T-120 (10/3/25) through T+5. Run-up high $117.62 on 12/17/25, low $85.86 on 3/18/26 (T-120 to T-1). FDA decision 3/20/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-03-20
OutcomeApproved
Drug / candidateIMCIVREE (setmelanotide)
CompanyRhythm Pharmaceuticals Inc.
120-day run-up (T-120→T-1)-8.9%