PDUFA target action date for Soleno’s DCCR extended by three months

The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ (Nasdaq: SLNO) the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS) in individuals four years and older who have hyperphagia.

The new Prescription Drug User Fee Act (PDUFA) target action date is March 27, 2025.

The FDA determined that responses to recent information requests constituted a major amendment to the NDA, resulting in the extension of the PDUFA goal date by three months. The extension allows the FDA time to complete their review, including that of the recently submitted information. However, Soleno noted that the FDA did not cite any safety, efficacy or manufacturing concerns in their correspondence.