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If you are an investor in Applied Therapeutics and have suffered losses, you may CLICK HERE to contact us. You may also contact Kaplan Fox by emailing jcampisi@kaplanfox.com or by calling (212) 329-8571.

DEADLINE REMINDER: If you are a member of the proposed Class, you may move the court no later than February 18, 2025 to serve as a lead plaintiff for the purported class.  If you have losses we encourage you to contact us to learn more about the lead plaintiff process.  You need not seek to become a lead plaintiff in order to share in any possible recovery.

According to the complaint, on November 27, 2024, the Company disclosed that the U.S. 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.” 

Following this news, on November 29, 2024, 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.”  According to the complaint, Applied Therapeutics’ stock price declined from a closing market price of $1.75 per share on December 2, 2024 to close at $1.29 per share on December 5, 2024.

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If you have any questions about this Notice, your rights, or your interests, please contact:

CONTACT:

Jeffrey P. Campisi

KAPLAN FOX & KILSHEIMER LLP
800 Third Avenue, 38th Floor
New York, New York 10022
(212) 329-8571

jcampisi@kaplanfox.com

Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
1999 Harrison Street, Suite 1560
Oakland, California 94612
(415) 772-4704
lking@kaplanfox.com