Rhythm Pharmaceuticals Announces FDA Extension of Review Period for IMCIVREE (setmelanotide) for Patients with Acquired Hypothalamic Obesity

Reuters11-20

Nov 7 (Reuters) - Rhythm Pharmaceuticals Inc ::
*RHYTHM PHARMACEUTICALS ANNOUNCES FDA EXTENSION OF REVIEW PERIOD FOR IMCIVREE® (SETMELANOTIDE) FOR PATIENTS WITH ACQUIRED HYPOTHALAMIC OBESITY
*RHYTHM PHARMACEUTICALS INC: FDA SETS UPDATED PDUFA GOAL DATE OF MARCH 20, 2026
*RHYTHM PHARMACEUTICALS INC: FDA SETS UPDATED PDUFA GOAL DATE OF MARCH 20, 2026
*RHYTHM PHARMACEUTICALS: FDA IN OCT REQUESTED ADDITIONAL SENSITIVITY ANALYSES OF EFFICACY DATA FROM PHASE 3 TRIAL IN ACQUIRED HYPOTHALAMIC OBESITY
*RHYTHM PHARMACEUTICALS INC: MAJOR AMENDMENT DID NOT INCLUDE ANY INFORMATION RELATING TO SAFETY OR MANUFACTURING OF SETMELANOTIDE

((Reuters Investor Briefs; email: reutersinvestor.briefs@thomsonreuters.com))
Source Date/Time = 07-NOV-202512:30:00.293 GMT

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