Rhythm Pharma rises after FDA clears therapy for hypothalamic obesity

Shares of drugmaker Rhythm Pharmaceuticals RYTM.O rise 6.3% to $96.03 premarket

Co said on Thursday the U.S. FDA approved its treatment, Imcivree, as the first therapy for acquired hypothalamic obesity, a rare form of obesity caused by damage to the brain region that regulates hunger and weight

Co said approval comes after late-stage trial showed patients on Imcivree cut body mass index by about 16% over a year, vs. an increase on those given placebo

RYTM added therapy was generally well-tolerated and common side effects included skin darkening, nausea, vomiting and headache

FDA approval allows therapy to be used in adults and children aged four and above

Imcivree was already approved for certain rare genetic forms of obesity; drug to be available immediately in the U.S. - Co

Shares of the company down about 16% YTD after nearly doubling in value in 2025