
Core Viewpoint - The article discusses a class action lawsuit against Applied Therapeutics, Inc. for alleged violations of the Securities Exchange Act of 1934, focusing on misleading statements regarding the company's drug application process and subsequent FDA responses [1][4][5]. Group 1: Lawsuit Details - The class action lawsuit is titled Alexandru v. Applied Therapeutics, Inc., and it involves purchasers of Applied Therapeutics securities from January 3, 2024, to December 2, 2024 [1]. - The lawsuit alleges that Applied Therapeutics and its executives made false statements and failed to disclose adherence issues with trial protocols, which posed a risk of FDA rejection of their New Drug Application (NDA) for govorestat [4][5]. - On November 27, 2024, the FDA issued a Complete Response Letter indicating that the NDA could not be approved in its current form due to deficiencies, leading to an over 80% drop in stock price over three trading sessions [5]. - On December 2, 2024, Applied Therapeutics disclosed receiving a warning from the FDA regarding electronic data capture issues and a dosing error, resulting in a further decline of over 26% in stock price over three trading sessions [6]. Group 2: Lead Plaintiff Process - The Private Securities Litigation Reform Act of 1995 allows any investor who purchased Applied Therapeutics securities during the class period to seek appointment as lead plaintiff, representing the interests of the class [7]. - The lead plaintiff is typically the investor with the greatest financial interest and must be typical and adequate of the class [7]. Group 3: Company Background - Applied Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel drug candidates for rare diseases [3]. - Robbins Geller Rudman & Dowd LLP, the law firm handling the case, is recognized for its success in securities fraud cases, having recovered $6.6 billion for investors in such cases [8].