The law firm of Kirby McInerney LLP reminds investors that a class action lawsuit has been filed in the U.S. District Court for the Southern District of New York on behalf of those who acquired Applied Therapeutics, Inc. (“Applied Therapeutics” or the “Company”) (NASDAQ: APLT) securities between January 3, 2024, to December 2, 2024 (“the Class Period”). Investors have until February 18, 2025, to apply to the Court to be appointed as lead plaintiff in the lawsuit.

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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 product candidate. The CRL indicated that the FDA had 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. On this news, the price of Applied Therapeutics shares declined by $6.54 per share, or approximately 76%, from $8.57 per share on November 27, 2024, to close at $2.03 per share on December 2, 2024.

Then, on December 2, 2024, after market hours, Applied Therapeutics disclosed that it had received a “warning letter” from the FDA referring to the clinical trial issues underlying the CRL. According to the Company’s description of the warning letter, the FDA stated in pertinent part that: “The letter identified issues related to electronic data capture, which the Company believes were addressed in prior communications with the agency, including by providing detailed paper and video records. The letter also refers to a dosing error in the dose escalation phase of the study resulting in slightly lower levels that targeted in a limited number of patients, which were remedied prior to achieving maintenance dosing identified issues related to electronic data capture and a dosing error in the dose-escalation phase of the study, resulting in slightly lower levels than targeted in a limited number of patients. On this news, the price of Applied Therapeutics shares declined by $0.49 per share, or more than 25%, over 3 consecutive days, from $1.75 per share on December 2, 2024, to $1.69 on December 3, 2024, $1.38 on December 4, 2024, and finally, to close at $1.29 on December 5, 2024.

The lawsuit alleges that Defendants, throughout the Class Period, misled investors by providing positive statements to investors, while at the same time concealing material adverse facts concerning the true state of Applied Therapeutic’s trials; notably, electronic data capture issues and a dosing error in the dose-escalation phase of the study.

If you purchased or otherwise acquired Applied Therapeutics securities, have information, or would like to learn more about this investigation, please contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@kmllp.com, or fill out the form below, to discuss your rights or interests with respect to these matters without any cost to you.

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Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website.

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