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.
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