Applied Therapeutics, Inc. Announces Successful Pre-Nda Meeting with the Fda and Confirms Plans to Submit Nda for Govorestat (At-007) for Treatment of Classic Galactosemia to Fda in Fourth Quarter 2023

Applied Therapeutics, Inc. announced successful completion of a recent pre-New Drug Application (?NDA?) meeting with the Food and Drug Administration (FDA) regarding its govorestat (AT-007) Galactosemia program. Based on discussions with the FDA, the Company believes they are aligned with the FDA and plans to submit an NDA for govorestat (AT-007) for the treatment of Galactosemia in the fourth quarter of this year.