04:25 AM EDT, 05/23/2025 (MT Newswires) -- Soleno Therapeutics ( SLNO ) said late Thursday that the European Medicines Agency validated the company's marketing authorization application for diazoxide choline tablets to treat hyperphagia in patients with Prader-Willi Syndrome.

The validation covers treatment of adults and children aged four years and above, the company said.

Soleno has received orphan drug designation for diazoxide choline in the European Union for Prader-Willi Syndrome treatment. This could provide the company with up to 10 years of market exclusivity in the region, if approved, it said.

Prader-Willi syndrome is a rare genetic neurodevelopmental disorder.