(RTTNews) - Rhythm Pharmaceuticals, Inc. (RYTM) announced that the FDA has approved IMCIVREE for the treatment of acquired hypothalamic obesity, marking the first and only therapy cleared for this rare and severe condition.
Acquired hypothalamic obesity develops after damage to the hypothalamus-often following treatment of brain tumors such as craniopharyngioma or astrocytoma- and leads to rapid, persistent weight gain due to disruption of the MC4R pathway. The newly expanded label allows IMCIVREE to be used to reduce excess body weight and maintain weight reduction in adults and children aged 4 years and older.
The approval is supported by results from the global Phase 3 TRANSCEND trial, which enrolled 142 patients. IMCIVREE achieved a placebo-adjusted BMI reduction of -18.4% with treated patients showing a -15.8% mean BMI decrease compared with a +2.6% increase in the placebo group at 52 weeks. The therapy was generally well tolerated, with the most common adverse events including skin hyperpigmentation, nausea, vomiting, and headache.
Rhythm estimates that approximately 10,000 people in the U.S. are living with acquired hypothalamic obesity. IMCIVREE is already approved for several rare genetic forms of obesity including Bardet-Biedl syndrome and POMC, PCSK1 or LEPR deficiency.
The company said IMCIVREE will be available to U.S. patients immediately.
IMCIVREE has been gaining traction. Global net product revenue was $57.3 million in the fourth quarter of 2025, up 12% sequentially from $51.1 million in the third quarter of 2025, and compared with $41.8 million in the fourth quarter of 2024.
For the full year, 2025, IMCIVREE generated $194.8 million in revenue, a 50% increase from $130.1 million in 2024.
RYTM has traded between $45.90 and $122.20 over the past year. The stock closed Thursday's trading at $90.31, up 5.18%. During the overnight trading, the stock rose further to $92.73, up 2.68%.
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