The FDA broadened approval of Rhythm Pharmaceuticals’ Imcivree to include adults and children aged 4 and older with acquired hypothalamic obesity, a condition caused by hypothalamic injury and rapid weight gain. In trials, Imcivree produced approximately 18 percentage points more weight loss than placebo in affected patients. Rhythm said the label expansion adds a new, well‑defined patient population and could materially broaden commercial opportunity; analysts estimate the addressable market in the low‑thousands to tens of thousands of patients. The approval followed additional analyses requested by the agency during review and represents a targeted regulatory win for a rare‑disease obesity therapy acting on the MC4R pathway.