06:25 AM EDT, 03/27/2025 (MT Newswires) -- (Updates with the stock move in the headline and the first paragraph.)

Soleno Therapeutics ( SLNO ) shares jumped 37% in premarket activity Thursday after the company said overnight that the US Food and Drug Administration approved its treatment for hyperphagia in adults and children with Prader-Willi Syndrome, a rare genetic disorder.

The approval for the company's VYKAT XR tablets was based on efficacy and safety data from a phase 3 trial, it said late Wednesday.

Soleno expects the tablets to be available in the US in April.