Class Action Lawsuit Opportunity for Investors in Applied Therapeutics, Inc.

The law firm Robbins Geller Rudman & Dowd LLP has recently issued a pivotal alert for investors who have purchased Applied Therapeutics, Inc. (NASDAQ: APLT) securities. Those who bought or acquired shares between January 3, 2024, and December 2, 2024, may have an opportunity to lead a class action lawsuit following substantial losses incurred during this period. This development brings attention to the ongoing legal issues surrounding this clinical-stage biopharmaceutical company, which engages in the development of novel drug candidates targeting rare diseases.

According to the details released, the specifics of the class action lawsuit, captioned Alexandru v. Applied Therapeutics, Inc., No. 24-cv-09715 (S.D.N.Y.), raises serious allegations against the company and its executive team. It contends that misleading statements were made regarding their compliance with trial protocols and good clinical practices. In particular, it claims that this lack of adherence significantly raised the risk that the FDA would reject the clinical trial data submitted by Applied Therapeutics.

The lawsuit points to a critical moment on January 3, 2024, when the defendants announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for govorestat, aimed at treating Classic Galactosemia. However, the class action asserts that the results from the trials were compromised due to deviation from established protocols.

On November 27, 2024, the FDA issued a Complete Response Letter regarding the NDA, indicating that they could not approve the application in its current form due to various deficiencies. This news reportedly caused a drastic over 80% drop in Applied Therapeutics' stock price over just three trading sessions.

Moreover, on December 2, 2024, the company disclosed receiving a warning from the FDA. This warning related to issues associated with electronic data capture and highlighted a dosing error during the study's dose-escalation phase, leading to further investor distress and a subsequent 26% decline in stock value following this revelation.

Under the Private Securities Litigation Reform Act of 1995, all investors who acquired APLT securities during the class period can apply to serve as the lead plaintiff in this lawsuit. The role of the lead plaintiff is crucial, as they typically have the greatest financial interest in the relief sought and represent the interests of all other affected investors.

Those interested in pursuing this opportunity should act swiftly, as the deadline for seeking appointment as lead plaintiff is February 18, 2025. Details on how to join can be found here.

Robbins Geller is well-regarded in the realm of securities fraud litigation, having recovered over $6.6 billion for investors in class action cases over the past few years. Their extensive experience in this field further solidifies the potential for a strong case on behalf of investors who have suffered significant financial losses.

For more information, feel free to reach out to attorneys J.C. Sanchez or Jennifer N. Caringal of Robbins Geller at 800-449-4900 or via email at [email protected].

Investors should remain vigilant regarding their legal rights and opportunities, especially during these challenging circumstances involving Applied Therapeutics. A well-informed investor is better prepared to navigate the complexities of the stock market and corporate governance issues that may arise in situations like this.