BOSTON, MA — January 9, 2026 — Leads & Copy — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) announced preliminary unaudited net product revenues from global sales of IMCIVREE® (setmelanotide) for the fourth quarter and full year of 2025 and upcoming milestones. The company, focused on rare neuroendocrine diseases, reported Q4 2025 preliminary net product revenues from global sales of IMCIVREE® (setmelanotide) of approximately $57 million, an 11% increase over Q3 2025. FY 2025 preliminary net product revenue was approximately $194 million, a 50% increase from FY2024.
Rhythm Pharmaceuticals anticipates a March 20, 2026 PDUFA goal date for sNDA for setmelanotide in acquired hypothalamic obesity. The company is on track to report topline data from a 12-patient Japanese cohort of the setmelanotide Phase 3 trial in acquired hypothalamic obesity in the first quarter of 2026.
The company is also on track to report topline data from the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases in the first quarter of 2026.
“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 added that Rhythm is focused on delivering sustainable, long-term growth as it prepares to launch IMCIVREE for patients with acquired hypothalamic obesity (HO) in the United States, pending FDA approval. The company is also anticipating top-line data readouts from the Japanese cohort of its Phase 3 trial in acquired HO and the Phase 3 EMANATE trial. Rhythm also plans to initiate a Phase 3 trial to evaluate its oral MC4R agonist, bivamelagon, in acquired HO and advancing setmelanotide and RM-718 for patients with Prader-Willi syndrome.
Rhythm expects net product revenues from global sales of IMCIVREE to be approximately $57 million for the fourth quarter of 2025, an 11% increase from the third quarter of 2025. Net product revenues for the full year of 2025 are expected to be approximately $194 million, compared to $130 million for the full year of 2024, a 50% increase year over year. U.S. sales of IMCIVREE contributed approximately 68% of fourth quarter preliminary unaudited net product revenues and approximately 69% of full-year 2025 preliminary unaudited net product revenues. The Company plans to report its fourth quarter and full year 2025 financial results in late February 2026.
The FDA’s assigned PDUFA goal date is March 20, 2026 for the launch of IMCIVREE in the United States for the treatment of acquired hypothalamic obesity pending FDA approval. The company expects to announce topline data in the 12-patient Japanese cohort of the setmelanotide Phase 3 trial in acquired HO in the first quarter of 2026.
Enrollment is expected to be completed in the setmelanotide Phase 3 trial substudy in congenital HO in the first half of 2026.
Topline data is anticipated to be announced in the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases in the first quarter of 2026.
In December 2025, Rhythm announced positive preliminary data for the exploratory phase 2 trial of setmelanotide in patients with PWS that showed BMI and hyperphagia reductions at month 3 and month 6, as well as safety and tolerability consistent with setmelanotide’s well-established clinical profile. Six-month results from 18 patients from the ongoing Phase 2 trial are expected to be announced in the first half of 2026.
Pending further feedback from U.S. and European regulatory agencies, a pivotal Phase 3 trial evaluating bivamelagon in acquired HO is expected to be initiated in 2026.
Enrollment is expected to be completed in the Phase 1, Part C trial evaluating the weekly, MC4R agonist RM-718 in patients with acquired HO in the first quarter of 2026.
David Connolly
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceuticals, Inc.
dconnolly@rhythmtx.com
Layne Litsinger
Real Chemistry
llitsinger@realchemistry.com
Source: Rhythm Pharmaceuticals
