Applied Therapeutics(US:APLT) Prnewswireยท2025-01-14 10:02Core 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 and failure to adhere to clinical trial protocols, which led to significant stock price declines following negative FDA responses [1][3][4]. Company Overview - Applied Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel drug candidates for rare diseases, specifically targeting validated molecular pathways [2]. Legal Allegations - The class action lawsuit alleges that during the class period from January 3, 2024, to December 2, 2024, Applied Therapeutics and its executives made false or misleading statements regarding the company's adherence to trial protocols, which posed a risk of FDA rejection of their New Drug Application (NDA) for govorestat [3][4]. - On November 27, 2024, it was revealed that the FDA issued a Complete Response Letter for the NDA, indicating that the application could not be approved in its current form due to clinical application deficiencies, resulting in an over 80% stock price drop over three trading sessions [4]. - On December 2, 2024, Applied Therapeutics disclosed receiving a warning from the FDA regarding issues with electronic data capture and a dosing error, leading to a further decline of more than 26% in stock price over three trading sessions [5]. Class Action Process - The Private Securities Litigation Reform Act of 1995 allows investors who purchased Applied Therapeutics securities during the class period to seek appointment as lead plaintiff in the lawsuit, representing the interests of all class members [6]. Law Firm Background - Robbins Geller Rudman & Dowd LLP is a leading law firm specializing in securities fraud cases, having secured over $6.6 billion for investors in class action cases, and is recognized for obtaining significant recoveries in securities litigation [7].