Rhythm Awaits FDA Decision On Expanded Use Of Imcivree In Hypothalamic Obesity

Rhythm Pharmaceuticals, Inc. (RYTM) is set to face a pivotal FDA decision tomorrow, March 20, 2026, on its sNDA to expand the label of Imcivree to include treatment of acquired hypothalamic obesity.

Imcivree (setmelanotide) is already FDA-approved for chronic weight management in adults and children aged two years and older with certain rare genetic forms of obesity, including Bardet-Biedl syndrome (BBS), POMC, PCSK1 or LEPR deficiency.

Subscribe to continue reading the article.
This article is part of our premium content offering.Subscribe with a RTTNews subscription.
Subscribe Now
Already subscribed? Sign in

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com