Core Viewpoint - The news highlights a class action lawsuit against Applied Therapeutics, Inc. due to significant stock price declines following the issuance of a Complete Response Letter (CRL) from the FDA regarding its lead drug candidate, govorestat [2][3]. Group 1: Company Overview - Applied Therapeutics, Inc. is facing legal action from shareholders who purchased shares during the class period from January 3, 2024, to December 2, 2024 [2]. - The company’s stock price experienced a dramatic decline of over 80%, dropping from 1.75 per share by December 2, 2024 [2]. Group 2: Regulatory Issues - On November 27, 2024, Applied Therapeutics announced it received a CRL from the FDA, indicating deficiencies in the clinical application of its New Drug Application (NDA) for govorestat [2]. - Following the CRL announcement, the company disclosed a "warning letter" from the FDA on December 2, 2024, which further impacted investor confidence and stock price [2]. Group 3: Shareholder Actions - Shareholders are encouraged to register for the class action lawsuit by February 18, 2025, to potentially be appointed as lead plaintiffs [3]. - Once registered, shareholders will receive updates through a portfolio monitoring software regarding the status of the case [3].
The Gross Law Firm Reminds Shareholders of a Lead Plaintiff Deadline of February 18, 2025 in Applied Therapeutics, Inc. Lawsuit - APLT