Soleno Therapeutics Inc. (NASDAQ: SLNO) has voluntarily withdrawn its European marketing authorization application for VIOKAT, a diazoxide choline prolonged-release tablet for treating Prader-Willi syndrome.

The application had been under review by the European Medicines Agency, with a decision previously expected in mid-2026. The company stated the withdrawal was a business and strategic decision that preserves the option to re-engage with regulators if a viable pathway emerges.

The company noted there is no assurance it will re-engage with the EMA regarding future regulatory submissions for VIOKAT in Europe. The withdrawal effectively pauses near-term prospects for European approval and commercialization of the treatment.

VIOKAT is designed to treat Prader-Willi syndrome, a rare genetic disorder that affects appetite control and causes chronic feelings of hunger. Any future regulatory steps in Europe would depend on subsequent interactions and decisions that were not detailed in the company's announcement.