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RYTM FDA decision: Mar 20, 2026

Updated ·next FDA decision on the calendar
✓ 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%

Questions

Was IMCIVREE (setmelanotide) approved by the FDA?

Yes. The FDA approved the application for IMCIVREE (setmelanotide) on March 20, 2026. The primary source is linked on this page.

Which company is behind IMCIVREE (setmelanotide)?

IMCIVREE (setmelanotide) is a Rhythm Pharmaceuticals Inc. (RYTM) program. The FDA decision came on March 20, 2026; the company's own announcement is linked on this page.

How did RYTM stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), RYTM moved -8.9%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.