NEW YORK - 
(NewMediaWire) - December 09, 2024 - Kaplan Fox & Kilsheimer LLP is investigating potential securities violations against Applied Therapeutics, Inc. (“Applied Therapeutics” or the “Company”) (NASDAQ: APLT).
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On November 27, 2024, after the markets closed, the Company disclosed that the Food and Drug Administration (“FDA”) issued a Complete Response Letter (“CRL”) for its new drug application for govorestat, AT-007-1002, for treatment of classic galactosemia (the “NDA”). The Company’s press release states that the “CRL indicate[d] 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 Friday, November 29, 2024, the first trading day following the news, Applied Therapeutics stock fell $6.54 per share, over 76%, to close at $2.03 per share on heavy trading volume.
Then, on December 2, 2024 after the markets closed, the Company disclosed in a Form 8-K filing that following issuance of the CRL, the Company received a warning letter limited to the AT-007-1002 study and that the warning letter identified issues relating to “electronic data capture” and a “dosing error in the dose-escalation phase of the study resulting in slightly lower levels than targeted in a limited number of patients, which was remedied prior to achieving maintenance dosing.”
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If you have any questions about this investigation, please contact:
Pamela A. Mayer
KAPLAN FOX & KILSHEIMER LLP
800 Third Avenue, 38th Floor
New York, New York 10022
(646) 315-9003
pmayer@kaplanfox.com
Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
1999 Harrison Street, Suite 1560
Oakland, California 94612
(415) 772-4704
lking@kaplanfox.com
