Business
Rhythm Pharmaceuticals Reports First Quarter 2025 Financial Results and Business Update
-- First quarter 2025 net product revenue from global sales of IMCIVREE® (setmelanotide) of $37.7 million -- -- Setmelanotide pivotal Phase 3 TRANSCEND trial
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"-- First quarter 2025 net product revenue from global sales of IMCIVREE® (setmelanotide) of $37.7 million -- -- Setmelanotide pivotal Phase 3 TRANSCEND trial met primary endpoint with -19.8% placebo-adjusted BMI reduction in patients (N=120) with acquired hypothalamic obesity -- -- U.S. and EU regulatory submissions for setmelanotide in acquired hypothalamic obesity on track to be completed in the third quarter of 2025 -- -- Topline data from Phase 2 trial of oral MC4R agonist bivamelagon on track to be announced in third quarter of 2025 -- -- Cash on-hand expected to support planned operations into 2027 -- -- Management to host conference call today at 8:00 a.m. ET -- BOSTON, May 07, 2025 (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 first quarter ended March 31, 2025. “Following compelling topline results from our pivotal Phase 3 trial of setmelanotide in acquired hypothalamic obesity (HO), we look forward to completing U.S. and EU regulatory submissions in the third quarter of 2025 and, pending approval, bringing the first-ever known approved therapy for this serious disease to patients,” said David Meeker, M.D., Chairman, Chief Executive Officer and President of Rhythm. “In addition, we are advancing our next-generation MC4R agonists as we are on track to read out topline data from the Phase 2 trial evaluating the oral-daily bivamelagon in patients with HO in the third quarter of 2025.” Dr. Meeker continued, “With BBS, we are pleased with the continued growth in the number of patients on reimbursed therapy with a steady increase in new physicians writing prescriptions in the United States along with the ongoing strong performance internationally. In addition, we believe Rhythm is well capitalized with cash runway into 2027, beyond multiple clinical and regulatory milestones expected this year and early next year.” First Quarter and Recent Business Highlights Revenue from global sales of IMCIVREE (setmelanotide) was $37.7 million for the first quarter of 2025. The number of patients on reimbursed therapy increased 14% in the first quarter of 2025 compared to the fourth quarter of 2024, as patient de...