Rhythm Pharmaceuticals Reports 18.8% Placebo-Adjusted BMI Drop, sNDA Decision Expected March 20
Rhythm Pharmaceuticals achieved an 18.8% placebo-adjusted BMI reduction at 52 weeks in its 142-patient Phase 3 TRANSCEND trial, with setmelanotide showing a mean -16.4% BMI change versus +2.4% for placebo. Its supplemental NDA for setmelanotide is under FDA review with a decision by March 20, potentially accelerating approval.
1. Phase 3 TRANSCEND Trial Results
The TRANSCEND trial enrolled 142 patients, including a 12-patient Japanese cohort, and achieved a mean BMI reduction of -16.4% on setmelanotide versus +2.4% on placebo at 52 weeks, delivering an 18.8% placebo-adjusted benefit. Treated patients aged 12 and older saw weekly hunger score declines of 2.5 points compared with 1.3 points for placebo.
2. Regulatory Progress
Rhythm’s supplemental NDA for setmelanotide is under FDA review with a target decision date of March 20. Company leadership highlighted that meeting both primary and key secondary endpoints positions setmelanotide to become the first approved therapy for acquired hypothalamic obesity.
3. Market and Analyst Response
Shares are trading near $93, approximately 9.8% below the 20-day SMA and 4.1% below the 100-day SMA, with a neutral RSI of 50.00 and a bearish MACD at 0.15 versus a 0.22 signal. Analysts maintain a buy consensus with an average price target of $131.33, including recent targets raised as high as $176.