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Applied Therapeutics issued a press release on November 27, 2024, announcing “that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of Classic Galactosemia.” According to the Company, “[t]he CRL indicates that the FDA completed its review of the application and determined that it is unable to approve the NDA in its current form, citing deficiencies in the clinical application.”
Following this news, Applied Therapeutics’ stock price fell sharply during after-hours trading on the same day.