APLT - FDA Grants Review Date For Applied Therapeutics' First Commercial Product For Rare Metabolic Disorder | Benzinga
Applied Therapeutics Inc (NASDAQ:APLT) shares are trading higher on Wednesday after the FDA accepted the filing of the New Drug Application (NDA) for govorestat (AT-007) for Classic Galactosemia.
The NDA was granted Priority Review status, and the FDA assigned a Prescription Drug User Free Act (PDUFA) target action date of August 28, 2024.
The FDA also noted that it plans to hold an advisory committee meeting to discuss the application.
Govorestat was previously granted Pediatric Rare Disease designation and will qualify for a Priority Review Voucher (PRV) upon approval.
If approved, govorestat would be the first medication indicated for the treatment of Galactosemia and would be ...