Rhythm Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide) for the treatment of acquired hypothalamic obesity. The FDA requested additional sensitivity analyses of clinical efficacy data from the Phase 3 trial, which led to the review period being extended by three months. The new Prescription Drug User Fee Act (PDUFA) goal date is March 20, 2026. No new safety or manufacturing data were requested, and the review remains ongoing. There is no indication that grant funding was obtained or that other organizations are involved in this announcement.