Applied therapeutics 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 q4 2023

New york, sept. 06, 2023 (globe newswire) -- applied therapeutics, inc. (nasdaq: aplt), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today 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.
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