Following the U.S. Food and Drug Administration extending the review period for the company's New Drug Application (NDA) for diazoxide choline extended-release tablets, Soleno Therapeutics (SLNO, Financial) saw its shares fall 17% in premarket trade Tuesday.
The treatment aims at hyperphagia in patients four years of age and above with Prader-Willi syndrome. The FDA's decision that responds to recent information requests significantly changed the NDA qualifies the review extension.
The government has thus established a new Prescription Drug User Fee Act (PDUFA) action deadline of March 27, 2025, so shifting the schedule by three months. The FDA did not express worries about the safety, efficacy, or manufacture of the medicine in spite of the delay Originally turning in the NDA on June 27, 2024, Soleno had it approved in August under Priority Review status.
