09:12 AM EDT, 10/08/2024 (MT Newswires) -- Soleno Therapeutics ( SLNO ) said Tuesday that the US Food and Drug Administration has determined there is no need at this time for an advisory committee meeting for its new-drug application for extended-release tablets of diazoxide choline, or DCCR, to treat Prader-Willi syndrome.

Soleno said that despite the determination, the FDA's Review Division will continue to consider whether an advisory committee meeting is necessary during the regulator's ongoing review.

Shares of Soleno were up 19% in recent Tuesday premarket activity.

Price: 56.92, Change: +9.29, Percent Change: +19.51