Additional positive data from the global Phase 3 TRANSCEND trial of setmelanotide in acquired hypothalamic obesity was announced. The data set included 12 patients from a Japanese cohort and 10 supplemental patients, adding to the primary 120-patient pivotal cohort, for a total of 142 patients in this analysis. Setmelanotide achieved an 18.8% placebo-adjusted difference in BMI reduction at 52 weeks. The primary endpoint showed a mean BMI reduction of -16.4% from baseline for patients on setmelanotide (n=94) compared to a +2.4% BMI change for patients on placebo (n=48) at 52 weeks (95% CI; p<0.0001). Among patients aged 12 and older (n=98), the setmelanotide group (n=66) demonstrated an average weekly reduction of 2.5 points in the weekly average most hunger score, versus a 1.3-point reduction in the placebo group (n=32) (p=0.0015). The company's supplemental New Drug Application (sNDA) for setmelanotide in acquired hypothalamic obesity is under FDA review with a PDUFA goal date of March 20, 2026. Rhythm will submit the final data package to the FDA on March 2, 2026, ahead of the previously agreed-upon submission date. The European Medicines Agency (EMA) is reviewing a Type II variation submission, with an anticipated CHMP opinion in Q2 2026 and potential marketing authorization in H2 2026. Plans are in place to submit the full data package to Japan's PMDA to seek marketing authorization.