03:17 AM EDT, 03/20/2026 (MT Newswires) -- Rhythm Pharmaceuticals ( RYTM ) said late Thursday the US Food and Drug Administration approved an expanded indication for Imcivree, or setmelanotide, for the treatment of acquired hypothalamic obesity.

The company said the FDA approval is based on results of its phase 3 trial of setmelanotide in 142 patients with acquired hypothalamic obesity. The study met its primary endpoint, according to the company.

Hypothalamic obesity is a rare disease characterized by accelerated and sustained weight gain caused by hypothalamic injury or dysfunction.