
Core Viewpoint - A lawsuit has been filed against Applied Therapeutics, Inc. and certain senior executives for potential violations of federal securities laws, following significant stock price declines after negative FDA communications regarding their lead drug candidate, govorestat [1][2]. Company Overview - Applied Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel drug candidates for rare diseases, with its lead candidate being govorestat, aimed at treating CNS rare metabolic diseases like Galactosemia [3]. Regulatory Developments - The company claimed that its New Drug Applications for govorestat were supported by positive clinical data, including a rapid reduction in galactitol and a favorable safety profile [4]. - On November 27, 2024, the FDA issued a Complete Response Letter for the NDA for govorestat, citing deficiencies in the clinical application, leading to an over 80% drop in stock price from $10.21 to $1.75 within a week [5]. - Following this, on December 2, 2024, the company received a warning letter from the FDA regarding issues in the govorestat study, causing an additional decline of over 26% in stock price from $1.75 to $1.29 [6]. Legal Actions - Investors have until February 18, 2025, to seek appointment as lead plaintiffs in the case, which is currently pending in the U.S. District Court for the Southern District of New York [2]. - The lawsuit asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors in Applied Therapeutics securities [2]. Investor Information - Investors are encouraged to submit their information to the law firm representing the plaintiffs, with no upfront costs for shareholders [7]. - The law firm has a strong track record in securities class actions, having recovered significant amounts for other clients in the past [9].