Cases & Investigations
Applied Therapeutics Securities Litigation

Wolf Popper LLP is Court-appointed Lead Counsel to Lead Plaintiff and the proposed Class of investors in Applied Therapeutics, Inc. common stock (“Applied,” NASDAQ: APLT) in the federal securities class action against Applied, its founder and former Chief Executive Officer, President, Secretary, and Chair Dr. Shoshana Shendelman, and its Chief Medical Officer Dr. Riccardo Perfetti. The action is brought on behalf of a proposed Class all persons who purchased or otherwise acquired publicly traded Applied common stock on a U.S. exchange between January 3, 2024 and December 2, 2024, inclusive (the “Class Period”). The litigation alleges claims under Sections 10(b) and 20(a) of the Exchange Act of 1934 and SEC Rule 10b-5 promulgated thereunder. A Consolidated Amended Complaint was filed in the Southern District of New York on May 2, 2025.
 
Applied is a clinical-stage biopharmaceutical company whose lead product candidate, govorestat (AT-007), is being developed to treat Classic Galactosemia, a rare pediatric metabolic disorder. At all relevant times, Applied had not received commercial approval for any drug, and govorestat was Applied’s lead drug candidate. 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 accepted and well-received.
 
However, throughout the Class Period, the defendants misled investors regarding the integrity of the clinical data supporting the NDA and their regulatory communications with the FDA.
 
Between March and June 2021, Applied administered only 80% of the dose of govorestat required pursuant to the protocol that the Company had agreed to with the FDA to at least 19 or 47 participants in its pediatric trial. Despite knowing of this issue since June 2021, the Company failed to disclose these dosing errors, or the clinical data resulting from these dosing errors, to the FDA in the NDA, and instead reported doses as if they had been properly administered.
 
Also, on March 27, 2024, just two days after the FDA pre-announced an inspection of Applied’s clinical testing sites, a third-party vendor deleted electronic clinical outcome assessment data, and the associated audit trails, for all 47 participants in the pediatric clinical trial.
 
The FDA discovered the dosing errors and the data deletion in its inspections of Applied’s clinical sites between April 27 and May 3, 2024. On May 3, 2024, the FDA gave a Form FDA 483 to Dr. Shendelman, which detailed three objectionable conditions discovered during the inspection, including the data deletion.  On May 9, 2024, Applied responded to the FDA and confirmed that it could not recovered the deleted data for 11 clinical subjects.
 
The dosing errors and the data deletion were violations of FDA regulations, and compromised the FDA’s ability to assess the NDA and verify and trust the clinical data submitted in support of 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. During investor conferences on May 14, 2024 and September 4, 2024, then-CEO Dr. 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. On September 18, 2024, Applied and Dr. Shendelman announced that the FDA had cancelled an upcoming advisory committee meeting to evaluate the NDA, and characterized this as a positive regulatory update. However, the defendants failed to disclose the known negative factors of the dosing errors and data deletion and that the FDA had discovered the data deletion through its inspection.
 
On November 27, 2024, after market close, Applied disclosed that the FDA issued a Complete Response Letter (“CRL”), declining to approve the NDA due to deficiencies in the clinical application. On December 2, 2024, after market close, the Company disclosed that it had also received a Warning Letter from the FDA. On December 3, 2024, the FDA published Warning Letter on its website, which revealed the dosing errors, that the NDA failed to mention the dosing errors or include the clinical data related to the dosing errors, and that Applied had been aware of the data deletion as early as May 3, 2024, and pharmaceutical news services covered the Warning Letter and rejection of the NDA on December 4 and 5, 2024.
 
In response to these disclosures, Applied’s stock fell from a closing price of $8.57 per share on November 27, 2024 $1.29 per share on December 5, 2024.
 
On December 20, 2024, during pre-market hours, Applied announced that on December 19, 2024, Dr. Shendelman had stepped down from her roles as President, CEO, Secretary, and Chair. In response, the price of Applied common stock fell from a closing price of $1.02 per share on December 19, 2024 to a closing price of $0.88 per share on December 20, 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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