Soleno Therapeutics, Inc.

Soleno Therapeutics announced FDA acceptance of its NDA for DCCR, a treatment for Prader-Willi syndrome, with a PDUFA target action date of December 27, 2024. The FDA plans an advisory committee meeting to discuss the application. DCCR has Breakthrough, Fast Track, and Orphan Drug Designations, aiming to address hyperphagia and other PWS symptoms.