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IMCIVREE (setmelanotide)

Rhythm Pharmaceuticals · $RYTM

Standard Review Orphan Drug Fast Track sNDA

PDUFA Date

March 20, 2026

Time Remaining

4d ago

Review Type

Standard (10 mo)

92%

Baseline PoA

Historical sNDA
approval rate

Dynamic PoA

Coming soon
xAI Sentiment

Indication

Acquired hypothalamic obesity

Key Notes

FDA extended PDUFA date from December 2025 to March 20, 2026 to allow additional review of clinical efficacy. IMCIVREE is already approved for other genetic obesity indications (POMC, PCSK1, LEPR deficiency, BBS, and LIPA deficiency). HO expansion could significantly grow addressable market.

⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.

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