Law Offices of Howard G. Smith announces an investigation on behalf of Applied Therapeutics, Inc. (“Applied Therapeutics” or the “Company”) (NASDAQ: APLT) investors concerning the Company’s possible violations of federal securities laws.

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.

If you purchased Applied Therapeutics securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847 or by email to howardsmith@howardsmithlaw.com, or visit our website at www.howardsmithlaw.com.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

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