Business
Rhythm Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Business Update
-- Fourth quarter 2025 net product revenue from global sales of IMCIVREE® (setmelanotide) of $57.3 million -- -- March 20, 2026 PDUFA goal date for sNDA for
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"-- Fourth quarter 2025 net product revenue from global sales of IMCIVREE® (setmelanotide) of $57.3 million -- -- March 20, 2026 PDUFA goal date for sNDA for setmelanotide in acquired hypothalamic obesity (HO) ---- Phase 2 open-label extension data showed bivamelagon achieved persistent BMI reductions at six and nine months; Completed positive end-of-Phase-2 meeting with FDA ---- On track to report topline data from 12-patient Japanese cohort of setmelanotide Phase 3 trial in acquired HO in March 2026 -- -- On track to report topline data from Phase 3 EMANATE trial evaluating setmelanotide in rare genetically caused melanocortin-4 receptor (MC4R) pathway diseases in March 2026 -- -- Management to host conference call today at 8:00 a.m. ET -- BOSTON, Feb. 26, 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 reported financial results and provided a business update for the fourth quarter and full year ended December 31, 2025. “Rhythm delivered solid IMCIVREE global sales growth and made continued progress developing therapies to address hyperphagia and severe obesity for people with rare MC4R pathway diseases in 2025,” said David Meeker, M.D., Chairman, Chief Executive Officer and President of Rhythm. “We enter 2026 focused on long-term growth and well-capitalized to achieve important commercial and clinical milestones. We are prepared to bring IMCIVREE to patients with acquired HO in the United States, pending FDA approval.\"He added, “We continue to advance clinical development of our next-generation of MC4R pathway agonists to improve patients’ lives. Following a highly constructive end-of-phase-2 meeting with the FDA where we shared encouraging open-label extension data focused on our oral MC4R agonist bivamelagon, we remain on track to initiate a Phase 3 trial evaluating bivamelagon in acquired HO by year-end 2026.” Recent Business Highlights Revenue from global sales of IMCIVREE was $57.3 million for the fourth quarter of 2025, an increase of 12% on a sequential basis from the third quarter of 2025, primarily driven by sales of IMCIVREE for the treatment of patients with Bardet-Biedl syndrome (BBS) and an increase in the number of patients on reimbursed therapy ...