Rhythm Pharma Phase 3 TRANSCEND trial meets primary endpoint with -19.8% placebo-adjusted BMI reduction in 120 patients

RHYTHM PHARMACEUTICALS, INC.

Mean BMI change of -16.5% on setmelanotide vs +3.3% for placebo at 52 weeks (p<0.0001); 80% achieved ≥5% BMI reduction.
Regulatory submissions in US and EU planned for Q3 2025; setmelanotide could become first approved therapy for acquired hypothalamic obesity.
Cash and short-term investments expected to fund operations into 2027.
No new safety signals; most common AEs were nausea, vomiting, diarrhea, injection site reaction, skin hyperpigmentation, headache.
Secondary endpoints: 83% of patients achieved ≥5% BMI or ≥0.2 BMI Z-score reduction; hunger score improved (p=0.003).

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