Rhythm Pharmaceuticals Announces FDA Extension of Review Period for IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity
Rhythm Pharmaceuticals, Inc. (RYTM)
Last rhythm pharmaceuticals, inc. earnings: 3/8 08:12 am
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Source: GlobeNewswire
-- FDA sets updated PDUFA goal date of March 20, 2026 – -- Company to hold conference today at 8:00 a.m. -- BOSTON, Nov. 07, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended by three months the review period for the supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide) for the treatment of acquired hypothalamic obesity. On Nov. 6, the FDA notified the Company that the Prescription Drug User Fee Act (PDUFA) goal date has been extended from December 20, 2025 to March 20, 2026. The FDA in October requested additional sensitivity analyses of clinical efficacy data from Rhythm’s Phase 3 pivotal trial in acquired hypothalamic obesity. No new data were requested. The additional information has been deemed a ‘major amendment,’ which al
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News
- Rhythm Pharmaceuticals (NASDAQ:RYTM) was upgraded by analysts at Citigroup Inc. to a "strong-buy" rating.MarketBeat
- Rhythm: Maintaining Strong Buy On Acquired Hypothalamic Obesity Drug Progress [Seeking Alpha]Seeking Alpha
- Rhythm Pharmaceuticals (NASDAQ:RYTM) is now covered by analysts at Citigroup Inc.. They set a "buy" rating on the stock.MarketBeat
- Rhythm Pharmaceuticals (NASDAQ:RYTM) had its price target raised by analysts at Canaccord Genuity Group Inc. from $105.00 to $114.00. They now have a "buy" rating on the stock.MarketBeat
- Rhythm Pharmaceuticals Announces Presentation of Four Datasets at ObesityWeek® 2025 [Yahoo! Finance]Yahoo! Finance
RYTM
Earnings
- 11/4/25 - Miss
RYTM
Sec Filings
- 11/24/25 - Form 4
- 11/20/25 - Form 144
- 11/14/25 - Form SCHEDULE
- RYTM's page on the SEC website