Soleno Stock Up as FDA Accepts PWS Drug NDA Under Priority Review

Soleno Therapeutics (SLNO) gained 6.3% on Aug. 27 after the FDA accepted the new drug application (NDA) seeking approval for its lead candidate, DCCR (diazoxide choline) extended-release tablets, to treat Prader-Willi syndrome (PWS) in patients aged four years and older who have hyperphagia, under the Priority Review pathway. A filing designated as a Priority Review reduces the review period to four months. A final decision from the FDA is expected on Dec. 27, 2024. The regulatory body in the United States ...