Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Applied Therapeutics, Inc. (“Applied Therapeutics” or the “Company”) (NASDAQ: APLT) securities between January 3, 2024 and December 2, 2024, inclusive (the “Class Period”). Applied Therapeutics investors have until February 18, 2025 to file a lead plaintiff motion.

Investors suffering losses on their Applied Therapeutics investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to howardsmith@howardsmithlaw.com.

On November 27, 2024, Applied Therapeutics disclosed that it had received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the New Drug Application (“NDA”) for the Company’s Classic Galactosemia drug, govorestat, stating that "[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."

On this news, Applied Therapeutics’ stock price fell $6.54, or 76.3%, to close at $2.03 per share on November 29, 2024, thereby injuring investors.

Then, on December 2, 2024, Applied Therapeutics disclosed that it had received a “warning letter” from the FDA regarding “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,” as well as “a dosing error in the dose-escalation phase” of the govorestat clinical trial.

On this news, Applied Therapeutics’ stock price fell $0.46, or 26.3%, over the next few consecutive trading days to close at $1.29 per share on December 5, 2024, thereby injuring investors further.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) Applied Therapeutics was not adhering to trial protocol and good clinical practices which, in turn, created an exceedingly severe risk that the trial data would be rejected by the FDA in the context of an NDA; and (2) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.

If you purchased Applied Therapeutics securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, by telephone at (215) 638-4847 or by email to howardsmith@howardsmithlaw.com, or visit our website at www.howardsmithlaw.com.

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