Soleno Therapeutics receives Breakthrough Therapy Designation for diazoxide choline extended-release tablets (DCCR) for treating Prader-Willi syndrome from the U.S. FDA.

Soleno Therapeutics receives Breakthrough Therapy Designation from the U.S. FDA for diazoxide choline extended-release tablets (DCCR) for treating adults and children with genetically confirmed Prader-Willi syndrome (PWS) who have hyperphagia. The designation is based on data from the Phase 3 clinical development program. Soleno's planned submission of a New Drug Application (NDA) for DCCR remains on track for mid-2024.

April 29, 2024
3 Articles