Rhythm Pharmaceuticals announces anticipated upcoming milestones

Rhythm expects to achieve the following near-term milestones: Complete submissions of a supplemental New Drug Application to the U.S. Food and Drug Administration and a Type II variation request to the European Medicines Agency seeking approval for setmelanotide for the treatment of acquired hypothalamic obesity in the third quarter of 2025; Disclose preliminary results from the Company’s setmelanotide Phase 2 trial in Prader-Willi syndrome in the second half of 2025; Complete enrollment in the Phase 1, Part C trial evaluating the weekly, MC4R agonist RM-718 in patients with acquired hypothalamic obesity in the first quarter of 2026; Announce topline data in the 12-patient Japanese cohort of the setmelanotide Phase 3 trial in acquired hypothalamic obesity in the first quarter of 2026; Announce topline data in the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases in the first quarter of 2026; Complete enrollment in the setmelanotide Phase 3 trial substudy in congenital hypothalamic obesity in the first half of 2026; and Pending alignment with U.S and European regulatory agencies, initiate a pivotal Phase 3 trial evaluating bivamelagon in acquired hypothalamic obesity in 2026. In addition, Rhythm announced today that it plans to host “Commercial Readiness for Acquired Hypothalamic Obesity”, an in-person and webcasted event for investors and analysts, on September 24, 2025, in Boston to review its global launch strategy for setmelanotide. The event will also feature insights from leading physicians about the urgent need to treat patients with acquired hypothalamic obesity. Registration details will follow.