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

Rhythm Pharmaceuticals

07/11/2025 12:41

Nov 7 (Reuters) - Rhythm Pharmaceuticals Inc RYTM.O:

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

Source text: ID:nGNX7pJwb9

Further company coverage: RYTM.O

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