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Rhythm Pharmaceuticals Receives Positive CHMP Opinion for IMCIVREE® (setmelanotide) for the Treatment of Obesity and Control of Hunger in Patients with Acquired Hypothalamic Obesity due to Hypothalamic Injury or Impairment

-- European Commission decision anticipated in second quarter of 2026 -- BOSTON, March 26, 2026 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending to expand the current marketing authorization for IMCIVREE® (setmelanotide) to include the treatment of obesity and the control of hunger in adults and children 4 years of age and above with acquired hypothalamic obesity (HO) due to hypothalamic injury or impairment.

PANTHERx® Rare Selected by Rhythm Pharmaceuticals Inc. as the Exclusive U.S. Specialty Pharmacy for the Expanded Indication for IMCIVREE® (setmelanotide)

PITTSBURGH, March 20, 2026 /PRNewswire/ -- PANTHERx® Rare Pharmacy, the trusted leader and innovator in patient access and support services for personalized rare disease care, announced that it was selected by Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), as the exclusive U.S. Pharmacy distribution partner for the expanded indication of IMCIVREE® (setmelanotide) for adults and children 4 years of age and older living with acquired hypothalamic obesity.1 Acquired hypothalamic obesity is a rare disease characterized by accelerated and sustained weight gain caused by an injury to the hypothalamus. Acquired hypothalamic obesity most frequently follows the growth or treatment of craniopharyngioma, astrocytoma or other hypothalamic-pituitary tumors.

Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity

-- 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 –

Rhythm Pharmaceuticals Announces Topline Results from Phase 3 EMANATE Trial

-- Four substudies did not meet pre-specified primary endpoints --  -- Post hoc analyses show setmelanotide achieved statistically significant BMI reductions in patients with obesity due to a heterozygous variant of the POMC/PCSK1 and SRC1 (NCOA1) genes at 52 weeks –