Rhythm reports Q1 2026 revenue growth as IMCIVREE launch in acquired HO gains traction
Rhythm reported Q1 2026 IMCIVREE revenue of $60.1 million and said more than 150 patient start forms were received after U.S. approval in acquired hypothalamic obesity. The company also cited European authorization and a Japanese application under review.
Rhythm Pharmaceuticals reported first-quarter 2026 financial results and a business update, including the U.S. launch of IMCIVREE for acquired hypothalamic obesity and net product revenue of $60.1 million from global sales of IMCIVREE. More than 150 patient start forms were received in the first six weeks following FDA approval on March 19, 2026, and the European Commission granted Marketing Authorization for the treatment of obesity and control of hunger in patients with acquired hypothalamic obesity.
The company said revenue from global sales of IMCIVREE was $60.1 million for the first quarter of 2026, an increase of 5% on a sequential basis from the fourth quarter of 2025, primarily driven by sales of IMCIVREE for the treatment of patients with Bardet-Biedl syndrome and an increase in the number of patients on reimbursed therapy globally. In the first quarter of 2026, revenue of $36.9 million, or 61% of product revenue, was generated in the United States, a decrease of 5% on a sequential basis primarily driven by specialty pharmacy inventory and some patients receiving drug under the company's bridging program as they transitioned insurance plans during the quarter. Revenue of $23.2 million, or 39% of product revenue, was generated outside the United States, a sequential increase of $4.9 million or 27%.
The company also said its Japanese New Drug Application for setmelanotide to treat acquired hypothalamic obesity has been accepted, validated and is now under review by Japan's Pharmaceuticals and Medical Devices Agency. The company anticipates the decision on the application in the second half of 2026 and, if positive, expects commercial launch by the end of 2026.
On May 4, 2026, the company announced new data presented at the Pediatric Endocrine Society Annual Meeting demonstrating sustained reductions in BMI and BMI Z-score through 2.5 years of setmelanotide treatment and observed weight category improvements in pediatric patients with acquired hypothalamic obesity. A second presentation demonstrated weight category improvement in the pediatric subpopulation of participants after 1 year of setmelanotide treatment.
On May 1, 2026, the European Commission granted Marketing Authorization to IMCIVREE for the treatment of obesity and control of hunger in patients with acquired hypothalamic obesity, following adoption of a positive opinion on March 26, 2026 recommending expansion of the current marketing authorization to include the treatment of acquired hypothalamic obesity. The company said launches in Europe are anticipated in 2027.
The company said it continues to advance ongoing trials of setmelanotide in Prader-Willi syndrome and its weekly injectable, RM-718, in acquired hypothalamic obesity. On April 3, 2026, the company announced the appointment of a new member to its Board of Directors and the resignation of another director.