FDA Approves First-Ever Treatment for Acquired Hypothalamic Obesity – IMCIVREE Now Available
Rhythm Pharmaceuticals receives FDA approval for IMCIVREE (setmelanotide) — the first and only treatment for acquired hypothalamic obesity.
Rhythm Pharmaceuticals receives FDA approval for IMCIVREE (setmelanotide) — the first and only treatment for acquired hypothalamic obesity.
Rhythm Pharmaceuticals announced that setmelanotide missed its primary endpoints in the Phase 3 EMANATE trial. Post-hoc analyses showed statistically significant BMI reductions in POMC/PCSK1 and SRC1 patients.
Rhythm Pharmaceuticals (RYTM) announces positive results from Phase 2 trial of setmelanotide for Prader-Willi syndrome, showing BMI reduction and decreased hunger in patients.
Rhythm Pharmaceuticals announced that the FDA has extended the review of its obesity drug Imcivree for acquired hypothalamic obesity by three months, moving the decision date to March 20, 2026.
Oppenheimer downgrades Rhythm Pharmaceuticals after major gains, while analysts issue fresh Buy ratings on Vanda, Verrica, CervoMed, and Ventyx highlighting key catalysts and growth potential.