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Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients with ...

FDA approval follows Phase 3 TRANSCEND trial showing an 18.4% placebo-adjusted BMI reduction in patients with acquired hypothalamic obesity, a condition lacking prior approved treatments.

Summary by Hastings Tribune
- First and only FDA-approved therapy for the treatment of acquired hypothalamic obesity, a rare disease characterized by accelerated and sustained weight gain caused by hypothalamic injury or dysfunction –

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Benzinga broke the news in New York, United States on Thursday, March 19, 2026.
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