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IMCIVREE (setmelanotide)

Rhythm Pharmaceuticals · $RYTM

Standard Review Orphan Drug Fast Track sNDA

PDUFA Date

March 20, 2026

Date Status

24d ago (past)

Review Type

Standard (10 mo)

92%

Baseline PoA

sNDA/sBLA historical approval rate

Based on FDA historical approval rates by submission type (2015–2025)

Dynamic PoA

Coming soon
xAI Sentiment

FDA Decision

✅

✓ FDA Approved

Decision issued: March 19, 2026

FDA APPROVED March 19, 2026 — 1 day before PDUFA target date of March 20. First and only FDA-approved therapy for acquired hypothalamic obesity (HO) in adults and pediatric patients 4+. Broad label not limited to tumor-related HO. Supported by Phase 3 TRANSCEND trial (18.4% placebo-adjusted BMI reduction at 52 weeks, n=142). EMA CHMP positive opinion also received March 26, 2026.

Source: https://www.globenewswire.com/news-release/2026/03/19/3259502/0/en/Rhythm-Pharmaceuticals-Announces-FDA-Approval-of-IMCIVREE-setmelanotide-for-Patients-with-Acquired-Hypothalamic-Obesity.html

Live Company Data NGM

Updated just now · Data: FMP

Current Price

$84.39 +45.93%

+$26.56 today

Day: $82.96 – $86.19

Market Cap

N/A

Shares out: 68.29M

Float: 55.45M

52-Week Range

$55.31

$122.20

Current price is at 43% of 52-week range

Avg Volume

838K

Beta

2.14

vs. S&P 500

Sector

Healthcare

Biotechnology

⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.

Indication

Acquired hypothalamic obesity

Key Notes

FDA APPROVED March 19, 2026 — 1 day before PDUFA target date. First and only FDA-approved therapy for acquired hypothalamic obesity (HO) in adults and pediatric patients aged 4 years and older. Supported by Phase 3 TRANSCEND trial (n=142; 18.4% placebo-adjusted BMI reduction at 52 weeks). Broad label — not limited to tumor-related hypothalamic injury. IMCIVREE is also approved for other genetic obesity indications (POMC, PCSK1, LEPR deficiency, BBS, LIPA deficiency). EMA CHMP adopted positive opinion for HO expansion on March 26, 2026. European Commission decision expected Q2 2026.

⚠️ 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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