According to the Company, "[t]he CRL indicates that the FDA completed its review of the application and determined that it is unable to approve the NDA in its current form, citing deficiencies in the clinical application." On this news, Applied Therapeutics' stock price fell $1.64 per share, or 16.06%, to close at $8.57 per share on November 27, 2024. Then, on December 3, 2024, the FDA posted on its website a Warning Letter to Applied Therapeutics, the contents of which indicated that the Company was aware at least as early as May 2024 that the FDA had identified significant issues in the govorestat NDA. On this news, Applied Therapeutics' stock price fell $0.31 per share, or 18.34%, to close at $1.38 per share on December 4, 2024. The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class.