A securities class action has been filed in the USDC — S.D.N.Y. against Applied Therapeutics, Inc. (APLT) (“MGPI”, or the “Company”), on behalf of all those that purchased or otherwise acquired Applied Therapeutics common stock between January 3, 2024, and December 2, 2024, both dates inclusive (the “Class Period”).
Applied Therapeutics is a clinical-stage biopharmaceutical company committed to the development of novel drug candidates against validated molecular targets in rare diseases. The Company’s lead drug candidate, Govorestat, is a central nervous system penetrant Aldose Reductase Inhibitor (ARI) for the treatment of CNS rare metabolic diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG.
The Complaint alleges that, on November 27, 2024, Applied Therapeutics issued a press release announcing that it had received a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, the Company’s lead drug candidate. The CRL indicated that the FDA completed its review of the application and determined that it was unable to approve the NDA in its current form citing deficiencies in the clinical application. Following this news, the price of Applied Therapeutics’ common stock declined dramatically. From a closing market price of $10.21 per share on November 26, 2024, Applied Therapeutics’ stock price fell to $8.57 per share on November 27, 2024 before falling further to $2.03 on November 29, 2024 and $1.75 per share on December 2, 2024, a total decline of more than 80%.
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