Wolf Popper LLP has been appointed Lead Counsel in a federal securities class action pending in the Southern District of New York against Applied Therapeutics, Inc. (NASDAQ: APLT), former CEO Shoshana Shendelman, and CMO Riccardo Perfetti. The action is brought on behalf of all persons and entities who purchased or otherwise acquired Applied Therapeutics common stock between January 3, 2024 and December 9, 2024, inclusive (the “Class Period”).
On March 11, 2025, the Honorable Denise Cote consolidated the related actions and appointed Dr. Martin Dietrich as Lead Plaintiff and Wolf Popper LLP as Lead Counsel. The amended consolidated complaint is due on May 2, 2025.
Applied Therapeutics is a clinical-stage biopharmaceutical company whose lead product candidate, govorestat (AT-007), was being developed to treat Classic Galactosemia, a rare pediatric metabolic disorder. In January 2024, Applied announced that it had submitted a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”), and the stock rose following public statements that the NDA was well-received.
However, throughout the Class Period, the Company and its CEO misled investors regarding the integrity of the clinical data supporting the NDA and their regulatory communications with the FDA.
In a 2021 Phase 1 trial, Applied administered only 80% of the protocol-required dose to at least 19 participants. Despite knowing of this issue since June 2021, the Company failed to disclose it to the FDA in the NDA, and instead reported doses as if they had been properly administered.
On March 27, 2024, just two days after an FDA inspection was preannounced, a third-party vendor deleted all electronic clinical outcome assessment data, and the associated audit trails, for all 47 participants in the registrational Phase 3 trial. This included primary and secondary efficacy endpoints. The FDA later found this to be a material violation of its data access rules under 21 C.F.R. § 312.58(a).
These issues compromised the FDA’s ability to assess the NDA. Yet, throughout the Class Period, Defendants made repeated public statements falsely assuring investors that the regulatory review was progressing smoothly. For example, in January and February 2024, the Company described its NDA as being supported by favorable clinical outcomes and safety data and claimed it was working closely with the FDA. Even after the FDA extended the review timeline in March 2024, Applied attributed the delay to routine requests for supplemental analyses. Notably, during investor conferences on May 14, 2024 and September 4, 2024, then-CEO Shoshana Shendelman explicitly stated that “things are going very well with the FDA” and that there were “no major sticking points” or “surprises” in the review process, despite knowing by that time that the FDA had uncovered serious issues, including the deletion of critical clinical trial data and undisclosed dosing errors, and had already issued formal inspection findings identifying regulatory violations.
On November 27, 2024, Applied disclosed that the FDA issued a Complete Response Letter (“CRL”), declining to approve the NDA due to clinical deficiencies. On December 2, 2024, the Company disclosed that it had also received a Warning Letter from the FDA, which revealed that Applied had been aware of serious deficiencies as early as May 2024, but did not disclose them during the Class Period.
Following these disclosures, Applied’s stock fell from $8.57 on November 27, 2024 to $2.03 on November 29, 2024, a 76% drop on heavy trading volume. The stock fell again after the Warning Letter, closing at $1.29 by December 5, 2024.
The case is In re Applied Therapeutics Securities Litigation, Case No. 1:24-cv-09715 (S.D.N.Y.), pending before the Honorable Denise L. Cote in the United States District Court for the Southern District of New York.
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