04:27 PM EDT, 08/20/2025 (MT Newswires) -- Rhythm Pharmaceuticals ( RYTM ) said late Wednesday that the US Food and Drug Administration (FDA) has accepted its supplemental New Drug Application for setmelanotide in acquired hypothalamic obesity, granting Priority Review and setting a Prescription Drug User Fee Act date of Dec. 20.

The European Medicines Agency has likewise validated a Type II variation to Rhythm's marketing application, with the review process starting earlier this month, the company added.

According to the report, the submissions are supported by favorable Phase 3 TRANSCEND trial data, which demonstrated meaningful body mass index reductions in both adult and pediatric patients.

Rhythm will host an investor event on Sept. 24 in Boston to outline US launch plans.