Rhythm(US:RYTM) Globenewswire·2026-01-09 13:00Core Viewpoint - Rhythm Pharmaceuticals reported strong preliminary unaudited net product revenues for IMCIVREE, indicating significant growth in 2025 and outlining future milestones for product development and regulatory approvals [2][3][6]. Financial Performance - Preliminary unaudited net product revenues for Q4 2025 are expected to be approximately $57 million, reflecting an 11% increase from Q3 2025 [3][6]. - Full-year 2025 net product revenues are projected to be around $194 million, a 50% increase compared to $130 million in 2024 [3][6]. - U.S. sales contributed approximately 68% of Q4 revenues and about 69% of full-year revenues for 2025 [3][6]. Upcoming Milestones - The company plans to launch IMCIVREE for acquired hypothalamic obesity in the U.S. pending FDA approval, with a PDUFA goal date set for March 20, 2026 [7]. - Top-line data from the Japanese cohort of the Phase 3 trial in acquired hypothalamic obesity is expected in Q1 2026 [6][8]. - Top-line data from the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases is also anticipated in Q1 2026 [6][8]. Product Development - Rhythm is advancing setmelanotide for Prader-Willi syndrome, with positive preliminary data from a Phase 2 trial showing reductions in BMI and hyperphagia [9]. - The company plans to initiate a pivotal Phase 3 trial for bivamelagon in acquired hypothalamic obesity in 2026, pending feedback from regulatory agencies [10]. - Enrollment in the Phase 1 trial for RM-718 is expected to be completed in Q1 2026 [11].