Applied Therapeutics, Inc. (NASDAQ: APLT)

This lawsuit is for anyone who acquired securities in Applied Therapeutics, Inc. (NASDAQ: APLT) from January 3, 2024 through December 2, 2024.

The lawsuit alleges that the Company and certain of its executives violated federal law. Specifically, the lawsuit alleges that, throughout the time period mentioned above, the Company misled investors regarding its financial condition. More specifically, the lawsuit alleges that the Company misled investors by telling investors that the Company had in place sufficient controls over the Company’s clinical trials of govorestat to allow for a positive FDA response to the Company’s New Drug Application, when the Company lacked such controls.

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, the price of the Company’s stock dropped precipitously on unusually heavy trading volume. Then, after market hours on December 2, 2024, Applied Therapeutics disclosed that it 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 than targeted in a limited number of patients, which was remedied prior to achieving maintenance dosing. Detailed records were maintained by the Company under FDA regulatory requirements, and this information was provided to FDA. The Company intends to respond within the permitted 15 business days to address these issues.” On this news, the price of the Company’s stock again dropped precipitously on unusually heavy trading volume.

The Law Offices of Howard G. Smith seeks to recover damages on behalf of class members. If you acquired securities in Applied Therapeutics, Inc. (NASDAQ: APLT) from January 3, 2024 through December 2, 2024 you may join the lawsuit by submitting your information online, or you may call the Law Offices of Howard G. Smith and speak to Mr. Smith directly to learn how he can protect your rights.