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Rhythm Pharmaceuticals Announces FDA Extension of Review Period for IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity
-- 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
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"-- 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 allows for additional time for the FDA to review. The major amendment did not include any information relating to the safety or manufacturing of setmelanotide. “Setmelanotide has demonstrated a compelling product profile, and we have every confidence that these additional sensitivity analyses confirm the strength of the data and setmelanotide’s potential to benefit patients with hypothalamic obesity,” said David Meeker, M.D., Chairman, Chief Executive Officer and President of Rhythm. “We appreciate and continue to collaborate with the FDA review team and we also are continuing to advance our preparations to deliver setmelanotide to a patient community that currently has no treatment options approved for acquired hypothalamic obesity.” Conference Call InformationRhythm Pharmaceuticals will host a live conference call and webcast at 8:00 a.m. ET today to discuss this update. Participants may register for the conference call here. It is recommended that participants join the call ten minutes prior to the scheduled start. A webcast of the call will also be available under \"Events and Presentations\" in the Investor Relations section of the Rhythm Pharmaceuticals website at https://ir.rhythmtx.com/. The archived webcast will be available on Rhythm Pharmaceuticals’ website approximately two hours after the conference call and will be available for 30 days follow...