Applied therapeutics announces fda acceptance and priority review of new drug application for govorestat for the treatment of classic galactosemia

Pdufa target action date of august 28, 2024 maa validated and accepted for review by ema in december 2023 new york, feb. 28, 2024 (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 that the u.s. food and drug administration (fda) has accepted the filing of the new drug application (nda) for govorestat (at-007) for the treatment of 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.
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