Rhythm Pharmaceuticals Stock Earnings Reports

Rhythm Pharmaceuticals reported Q3 2025 results and provided business and regulatory updates. Key highlights: Q3 net product revenue was $51.3M (up sequentially), driven by continued growth in IMCIVREE for Bardet-Biedl syndrome (BBS) with a ~10% increase in patients on reimbursed therapy; the company closed a $189M equity offering and ended Q3 with ~$416M cash, providing at least 24 months of runway. Regulatory progress: FDA accepted an sNDA for acquired hypothalamic obesity (HO) with a PDUFA date of December 20, 2025; EMA validated the EU filing with a potential CHMP opinion and EU approval in H2 2026. Clinical programs: preliminary Phase II Prader-Willi syndrome (PWS) data expected by year-end (small open-label cohort, 10–20 patients, interpreted patient-by-patient), RM-718 and bivamelagon programs advancing (next-gen oral MC4R inhibitor bivamelagon showed encouraging Phase II data). Commercial preparations for an acquired HO launch are well underway (U.S. field expansion, payer engagement, ~2,400 top-tier endocrinologist targets and ~2,000 identified potential HO patients). International progress: IMCIVREE available in 25+ countries; France reimbursement finalized for BBS/POMC/LEPR and early-access HO programs in France and Italy expanding. Financials: Q3 GAAP loss per share $0.82; Q3 operating spend increased (R&D and SG&A) to support launches and development; updated 2025 non-GAAP operating expense guidance $295–315M (R&D $150–165M; SG&A $145–150M). Upcoming catalysts include the PDUFA decision (Dec 20), preliminary PWS data (Dec), multiple international and trial readouts in Q1 2026, and Phase III planning for bivamelagon.