Business
Rhythm Pharmaceuticals Announces Preliminary, Unaudited Fourth Quarter and Full Year 2025 Net Product Revenues and Upcoming Milestones
-- Q4 2025 preliminary net product revenues from global sales of IMCIVREE® (setmelanotide) of approximately $57 million for the fourth quarter of 2025, an 11%
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"-- Q4 2025 preliminary net product revenues from global sales of IMCIVREE® (setmelanotide) of approximately $57 million for the fourth quarter of 2025, an 11% increase over Q3 2025 -- -- FY 2025 preliminary net product revenue of approximately $194 million, approximately 50% increase from FY2024 -- -- March 20, 2026 PDUFA goal date for sNDA for setmelanotide in acquired hypothalamic obesity -- -- On track to report topline data from 12-patient Japanese cohort of setmelanotide Phase 3 trial in acquired hypothalamic obesity in first quarter of 2026 -- -- On track to report topline data from Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases in first quarter of 2026 -- BOSTON, Jan. 09, 2026 (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 preliminary unaudited net product revenues from global sales of IMCIVREE® (setmelanotide) for the fourth quarter and full year of 2025 and upcoming milestones. “2025 was a year of strong execution and reflects significant progress toward our mission of transforming the lives of patients with rare neuroendocrine diseases,” said David Meeker, M.D., Chairman, Chief Executive Officer and President of Rhythm. “Our preliminary fourth quarter and full-year 2025 net product revenues reflect consistent growth in both the United States and international markets, driven by a steady increase in patients on reimbursed therapy and continued progress in securing access to IMCIVREE.” Dr. Meeker continued, “Looking ahead, we are focused on delivering sustainable, long‑term growth as we prepare to launch IMCIVREE for patients with acquired hypothalamic obesity (HO) in the United States, pending FDA approval. Additionally in 2026, we are excited about top-line data readouts from the Japanese cohort of our Phase 3 trial in acquired HO and the Phase 3 EMANATE trial, initiating a Phase 3 trial to evaluate our oral MC4R agonist, bivamelagon, in acquired HO and advancing setmelanotide and RM-718 for patients with Prader-Willi syndrome.” Preliminary Unaudited Fourth Quarter and Full Year 2025 Net Product RevenuesBased on preliminary unaudited financial information, Rhythm expects net product revenues from global s...