| COMPANY |
Applied Therapeutics, Inc. |
| COURT |
United States District Court for the Southern District of New York |
| CASE NUMBER |
1:24-cv-9715 |
| JUDGE |
The Hon. Denise L. Cote |
| CLASS PERIOD |
January 3, 2024, and December 2, 2024 |
| SECURITY TYPE |
Securities |
LEAD PLAINTIFF DEADLINE IS FEBRUARY 18, 2025.
If you have suffered losses and would like to discuss your rights, please fill out this form or you may contact Jonathan Naji, Esq. at (484) 270-1453 or via e-mail at info@ktmc.com.
Case Background:
The Class Period begins on January 3, 2024, when Applied Therapeutics issued a press release announcing that the company submitted a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for govorestat (AT-007) for the treatment of Classic Galactosemia.
On November 27, 2024, Applied Therapeutics revealed that the FDA issued a Complete Response Letter for the NDA for govorestat which indicated 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 fell more than 80% over the course of multiple trading days, from a closing price of $10.21 per share on November 26, 2024, to a closing price of $1.75 per share on December 2, 2024.
On December 2, 2024, Applied Therapeutics disclosed that the company received a warning from the FDA which “identified issues related to electronic data capture” and “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.” On this news, Applied Therapeutics stock fell more than 26% over the course of multiple trading days, from a closing price of $1.75 per share on December 2, 2024, to a closing price of $1.29 per share on December 5, 2024.
The complaint alleges that, throughout the Class Period, Defendants made false and/or misleading statements and/or failed to disclose that Applied Therapeutics was not adhering to trial protocol and good clinical practices for its drug candidate, govorestat, which, in turn, created an exceedingly severe risk that the trial data would be rejected by the FDA in the context of an NDA.
Whatis a Lead Plaintiff?
A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Filling out the online form above or communicating with any counsel is not necessary to participate or share in any recovery achieved in this case. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.