Rhythm Pharmaceuticals reported additional 52-week data from its global Phase 3 TRANSCEND trial of setmelanotide in patients with acquired hypothalamic obesity, including 12 patients from Japan and 10 supplemental patients beyond the primary pivotal cohort. Across all patients (N=142), the company reported a -18.8% placebo-adjusted difference in BMI reduction at 52 weeks; mean BMI change was -16.4% with setmelanotide (n=94) versus +2.4% with placebo (n=48), and in patients aged 12 and older, weekly average most hunger scores decreased by 2.5 points with setmelanotide versus 1.3 points with placebo. The company said topline results from the pre-specified 120-patient pivotal cohort were previously disclosed in April 2025, and that its U.S. sNDA for this indication is under FDA review with a March 20, 2026 PDUFA goal date.
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