Rhythm Pharma wins FDA approval for IMCIVREE in acquired hypothalamic obesity; Phase 3 shows -18.4% BMI reduction

RHYTHM PHARMACEUTICALS, INC.

FDA approved IMCIVREE (setmelanotide) for acquired HO in adults and children 4+; first approved therapy for this indication.
Phase 3 TRANSCEND: setmelanotide (-15.8% BMI) vs placebo (+2.6%) at 52 weeks; placebo-adjusted -18.4% (p<0.0001).
Most common AEs (>20%): skin hyperpigmentation, nausea, vomiting, headache.
Rhythm estimates ~10,000 U.S. patients with acquired HO; drug available immediately.
IMCIVREE already approved for BBS and monogenic obesity due to POMC/PCSK1/LEPR deficiency.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.