Soleno Therapeutics (NASDAQ:SLNO) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for DCCR (diazoxide choline) extended-release tablets meant to treat Prader-Willi Syndrome (PWS).
The FDA will now review the application to determine if it will be accepted.
Soleno has requested Priority Review, which could result in a six-month target review period if the NDA is accepted.