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.
FDA record of the action: the FDA approved on March 19, 2026, per NDA 213793 SUPPL-9 (FDA letter). The sponsor announced it on March 20, 2026. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Specialist biotech funds holding RYTM, 13F for the quarter ended June 30, 2026
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Questions
Was IMCIVREE (setmelanotide) approved by the FDA?
Yes. The FDA approved the application for IMCIVREE (setmelanotide) on March 19, 2026, per the FDA's own record. The company announced it 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 19, 2026; the FDA's own record of the decision 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.
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