Expanded Phase 3 Data for Setmelanotide Reveals 18.8% BMI Reduction in Hypothalamic Obesity
RYTM has more than doubled off its 52-week low of $45.905.
Summary
Rhythm Pharmaceuticals announced additional positive 52-week data from its Phase 3 TRANSCEND trial of setmelanotide in patients with acquired hypothalamic obesity. The expanded dataset, which includes 142 patients (including Japanese and supplemental cohorts), demonstrated an 18.8% placebo-adjusted difference in BMI reduction. Furthermore, patients on setmelanotide showed a significant average weekly reduction of 2.5 points in hunger scores. This new, detailed efficacy data further strengthens the clinical profile of setmelanotide, building on previously announced positive topline results. The company's supplemental New Drug Application (sNDA) is under FDA review with a PDUFA goal date of March 20, 2026, and the final data package will be submitted to the FDA on March 2, 2026. This robust data package enhances confidence in the drug's potential regulatory approval and market adoption, making the upcoming PDUFA date a critical catalyst.
At the time of this announcement, RYTM was trading at $92.66 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $6.3B. The 52-week trading range was $45.91 to $122.20. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.