Applied Therapeutics, Inc.

Background

Company Name	Applied Therapeutics, Inc.
Stock Symbol	APLT
Class Period	January 03, 2024 to December 02, 2024
Lead Plaintiff Motion Deadline	February 18, 2025

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Additional Comments

Background

On November 27, 2024, Applied Therapeutics disclosed that it had received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the New Drug Application (“NDA”) for the Company’s Classic Galactosemia drug, govorestat, stating that "[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 $6.54, or 76.3%, to close at $2.03 per share on November 29, 2024, thereby injuring investors.

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