RM-718

May 5, 2026: Rhythm Pharmaceuticals, Inc. (NASDAQ: RYTM) reported Q1 2026 results and provided catalyst updates across IMCIVREE (setmelanotide), RM-718, and bivamelagon.

IMCIVREE (setmelanotide) – acquired hypothalamic obesity (HO): FDA approval was granted March 19, 2026; the U.S. launch has generated >150 patient start forms in the first six weeks. The European Commission granted Marketing Authorization on May 1, 2026 following CHMP’s positive opinion on March 26, 2026; country-level launches are anticipated in 2027. In Japan, Rhythm said its JNDA has been accepted/validated and is under PMDA review; a decision is anticipated in 2H 2026, with a potential launch by end of 2026. The company also cited Pediatric Endocrine Society meeting data (May 4, 2026) showing sustained BMI and BMI Z-score reductions through 2.5 years in pediatric acquired HO (n=10).

Setmelanotide – genetically caused MC4R pathway diseases: Phase 3 EMANATE topline results (March 16, 2026) missed the primary endpoint in each of four independent substudies; post-hoc signals were reported in SRC1 (NCOA1) deficiency and POMC insufficiency.

Upcoming readouts: six-month Phase 2 setmelanotide data in Prader-Willi syndrome in Q2 2026; RM-718 weekly MC4R agonist acquired HO Part C results mid-2026; pivotal Phase 3 bivamelagon in acquired HO planned by year-end 2026.

Financials: Q1 2026 IMCIVREE net product revenue $60.1M globally; cash/cash equivalents/short-term investments $340.6M as of March 31, 2026.