Rhythm's therapy, setmelanotide, has been approved by the Food and Drug Administration (FDA) for the first time to treat acquired hypothalamic obesity, a condition that causes excess and sustained weight gain due to injuries to the brain. The therapy, already approved under the brand name Imcivree, is designed to activate the MC4R pathway in the brain to reduce hunger and stimulate the body's metabolism. The approval is backed by a late-stage study that found setmelonotide reduced weight by 15.8% as measured on the body mass index (BMI) at 52 weeks, compared with a 2.6% increase for patients on placebo.