The Law Offices of Frank R. Cruz reminds investors of the upcoming February 18, 2025 deadline to participate as a lead plaintiff in the securities fraud class action lawsuit filed on behalf of investors who acquired Applied Therapeutics, Inc. (“Applied Therapeutics” or the “Company”) (NASDAQ: APLT) securities between January 3, 2024 and December 2, 2024, inclusive (the “Class Period”).

IF YOU ARE AN INVESTOR WHO LOST MONEY ON APPLIED THERAPEUTICS, INC. (APLT), CLICK HERE TO PARTICIPATE IN THE SECURITIES FRAUD LAWSUIT.

What Happened?

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.

Then, on December 2, 2024, Applied Therapeutics disclosed that it had received a “warning letter” from the FDA regarding “issues related to electronic data capture, which the Company believes were addressed in prior communications with the agency, including by providing detailed paper and video records,” as well as “a dosing error in the dose-escalation phase” of the govorestat clinical trial.

On this news, Applied Therapeutics’ stock price fell $0.46, or 26.3%, over the next few consecutive trading days to close at $1.29 per share on December 5, 2024, thereby injuring investors further.

What Is The Lawsuit About?

The complaint filed alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) Applied Therapeutics was not adhering to trial protocol and good clinical practices which, in turn, created an exceedingly severe risk that the trial data would be rejected by the FDA in the context of an NDA; and (2) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.

If you purchased or otherwise acquired Applied Therapeutics securities between January 3, 2024 and December 2, 2024, the deadline to seek appointment as the lead plaintiff in the securities fraud class action is February 18, 2025.

Contact Us To Participate or Learn More:

If you wish to learn more about this class action, or if you have any questions concerning this announcement or your rights or interests with respect to the pending class action lawsuit, please contact us:

Frank R. Cruz

The Law Offices of Frank R. Cruz,

2121 Avenue of the Stars, Suite 800,

Century City, California 90067

Email us at: info@frankcruzlaw.com

Call us at: 310-914-5007

Visit our website at www.frankcruzlaw.com

Follow us for updates on Twitter: twitter.com/FRC_LAW

If you inquire by email, please include your mailing address, telephone number, and number of shares purchased.

To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250214372050/en/