Cases & Investigations
Applied Therapeutics, Inc.
Type: Investigations
Stock Symbol: NASDAQ: APLT
Wolf Popper LLP is investigating potential claims on behalf of purchasers of Applied Therapeutics, Inc. (“Applied Therapeutics”) common stock (NASDAQ: APLT).
Applied Therapeutics is a clinical-stage biopharmaceutical company. Applied Therapeutics’ leading drug candidate is govorestat (AT-007), which is used to treat Galactosemia and Sorbitol Dehydrogenase Deficiency. Galactosemia is a devastating rare pediatric metabolic disease. On January 3, 2024, Applied Therapeutics announced it submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) in December 2023 for the treatment of Classic Galactosemia.
After the market closed on November 27, 2024, Applied Therapeutics announced the FDA had issued a Complete Response Letter for the NDA for govorestat. The press release stated “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.” On this news, Applied Therapeutics’ stock price plummeted $6.54 per share to $2.03 on November 29, 2024, down 76.3% on extremely heavy volume.
After the market closed on December 2, 2024, Applied Therapeutics disclosed it received a Warning Letter from the FDA. On December 3, 2024, the FDA posted the Warning Letter on its website. The letter made it clear that Applied Therapeutics knew since at least May 2024 that the FDA had significant issues with the govorestat NDA.
Applied Therapeutics is a clinical-stage biopharmaceutical company. Applied Therapeutics’ leading drug candidate is govorestat (AT-007), which is used to treat Galactosemia and Sorbitol Dehydrogenase Deficiency. Galactosemia is a devastating rare pediatric metabolic disease. On January 3, 2024, Applied Therapeutics announced it submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) in December 2023 for the treatment of Classic Galactosemia.
After the market closed on November 27, 2024, Applied Therapeutics announced the FDA had issued a Complete Response Letter for the NDA for govorestat. The press release stated “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.” On this news, Applied Therapeutics’ stock price plummeted $6.54 per share to $2.03 on November 29, 2024, down 76.3% on extremely heavy volume.
After the market closed on December 2, 2024, Applied Therapeutics disclosed it received a Warning Letter from the FDA. On December 3, 2024, the FDA posted the Warning Letter on its website. The letter made it clear that Applied Therapeutics knew since at least May 2024 that the FDA had significant issues with the govorestat NDA.
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Wolf Popper LLP Announces Investigation on Behalf of
Applied Therapeutics, Inc. Investors
Case Update | 12/6/2024