According to the complaint, on November 27, 2024, Applied Therapeutics issued a press release announcing that it had received a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, the Company’s lead drug candidate. The CRL indicated that the FDA completed its review o...
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According to the complaint, on November 27, 2024, Applied Therapeutics issued a press release announcing that it had received a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, the Company’s lead drug candidate. The CRL indicated that the FDA completed its review of the application and determined that it was unable to approve the NDA in its current form citing deficiencies in the clinical application. Following this news, the price of Applied Therapeutics’ common stock declined dramatically. From a closing market price of $10.21 per share on November 26, 2024, Applied Therapeutics’ stock price fell to $8.57 per share on November 27, 2024 before falling further to $2.03 on November 29, 2024 and $1.75 per share on December 2, 2024, a total decline of more than 80%. After market hours on December 2, 2024, Applied Therapeutics disclosed it received a “warning letter” from the FDA referring to the clinical trial issues underlying the CRL. Applied Therapeutics’ disclosure of the “warning letter” prompted a further decline in the stock price as investors discovered the seriousness and severity of the Company’s clinical trial errors. From a closing market price of $1.75 per share on December 2, 2024, Applied Therapeutics’ stock price fell to $1.69 per share on December 3, 2024 before falling further to $1.38 per share on December 4, 2024 and $1.29 per share on December 5, 2024.