06:01 PM EDT, 03/26/2025 (MT Newswires) -- Soleno Therapeutics ( SLNO ) said the US Food and Drug Administration approved the company's VYKAT XR tablets to treat hyperphagia in adults and children with Prader-Willi Syndrome, a rare genetic disorder.
The approval was based on efficacy and safety data from a phase 3 trial, the company said Wednesday in a statement.
Soleno expects VYKAT XR to be available in the US in April.