Rhythm Pharmaceuticals reports $57M Q4 revenue, 50% annual growth

Rhythm Pharmaceuticals Inc. (NASDAQ: RYTM) reported preliminary unaudited net product revenues of approximately $57 million for the fourth quarter of 2025, representing an 11% increase from the third quarter of 2025, according to a company statement.

The biopharmaceutical company's full-year 2025 preliminary net product revenue reached approximately $194 million, compared to $130 million in 2024, marking a 50% year-over-year increase. U.S. sales of IMCIVREE accounted for approximately 68% of fourth quarter revenues and 69% of full-year 2025 revenues.

The company has a March 20, 2026 PDUFA goal date from the FDA for its supplemental new drug application for setmelanotide in acquired hypothalamic obesity. Rhythm expects to report topline data from a 12-patient Japanese cohort of its setmelanotide Phase 3 trial in acquired hypothalamic obesity during the first quarter of 2026.

Additional Phase 3 trial results are anticipated in the first quarter of 2026 from the EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases. The company also plans to complete enrollment in a setmelanotide Phase 3 trial substudy in congenital hypothalamic obesity in the first half of 2026.

In December 2025, Rhythm announced preliminary data from an exploratory Phase 2 trial of setmelanotide in patients with Prader-Willi syndrome, showing BMI and hyperphagia reductions at three and six months. Six-month results from 18 patients in the ongoing Phase 2 trial are expected in the first half of 2026.

The company plans to report its complete fourth quarter and full year 2025 financial results in late February 2026. IMCIVREE is currently approved by the FDA for treating hyperphagia and severe obesity in patients with specific genetic conditions including Bardet-Biedl syndrome and certain genetic deficiencies.

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