APLT - FDA Presses Delay Button For Applied Therapeutics' First Potential Marketed Drug For Rare Disease | Benzinga
Thursday, the FDA extended the review period for Applied Therapeutics Inc’s (NASDAQ:APLT) New Drug Application (NDA) for govorestat (AT-007) for the treatment of Classic Galactosemia by three months.
The FDA has set a new Prescription Drug User Fee Act (PDUFA) target action date of November 28, 2024, from the initial date of August 28, 2024.
The FDA notified Applied Therapeutics that it required additional time to review supplemental analyses of previously submitted data provided by Applied in response to the FDA’s routine information requests and determined that the additional information constitutes a Major Amendment to the NDA.
In February 2024, ...