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%, from $8.57 per share on November 27, 2024, to close at $2.03 on November 29, 2024.
If you purchased or otherwise acquired Applied Therapeutics securities, have information, or would like to learn more about this investigation, contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@kmllp.com, or by filling out this CONTACT FORM, to discuss your rights or interests with respect to these matters without any cost to you.
Kirby McInerney LLP is a New York-based plaintiffs' law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm's efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars.
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Contacts
Kirby McInerney LLP
Thomas W. Elrod, Esq.
212-699-1180
https://www.kmllp.com
investigations@kmllp.com

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