08:02 AM EST, 11/07/2025 (MT Newswires) -- Rhythm Pharmaceuticals ( RYTM ) said Friday the US Food and Drug Administration extended the review period for its supplemental new drug application for Imcivree, or setmelanotide, for treating acquired hypothalamic obesity by three months to March 20, 2026, from December 20, 2025.

The company said the extension follows an October request from the FDA for additional sensitivity analyses of clinical efficacy data from the company's phase 3 pivotal trial in acquired hypothalamic obesity and added that no new data were requested.

Rhythm shares fell 1.7% in premarket trading.