On Wednesday, Applied Therapeutics, Inc (NASDAQ:APLT) received an FDA Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat for Classic Galactosemia.
Galactosemia is a rare genetic metabolic disease resulting in an inability to metabolize the simple sugar galactose. When not appropriately metabolized, galactose is converted to the toxic metabolite, galactitol, which causes neurological complications.
