Investors Urged to Act Before Deadline in Applied Therapeutics Class Action

The Law Offices of Howard G. Smith remind investors of the upcoming February 18, 2025 deadline to file a lead plaintiff motion in the case concerning investors who bought Applied Therapeutics, Inc. (“Applied Therapeutics” or the “Company”) APLT securities between January 3, 2024 and December 2, 2024, known as the “Class Period.”

Attention Affected Investors of Applied Therapeutics (APLT): Your Opportunity to Join the Lawsuit!

If you have experienced a loss in Applied Therapeutics, get in touch with the Law Offices of Howard G. Smith to discuss your legal rights. You can reach them via email at howardsmith@howardsmithlaw.com, by phone at (215) 638-4847, or visit their website at www.howardsmithlaw.com.

Background on the Incident

On November 27, 2024, Applied Therapeutics announced it had received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the New Drug Application (“NDA”) for its Classic Galactosemia treatment, govorestat. The letter indicated that the FDA completed its review but could not approve the NDA in its current form due to deficiencies in the clinical data.

As a direct result, Applied Therapeutics’ stock price plummeted by $6.54, or 76.3%, closing at $2.03 per share on November 29, 2024, resulting in significant losses for investors.

Further compounding the issue, on December 2, 2024, the Company revealed it had received a “warning letter” from the FDA concerning issues with electronic data capture and a dosing error in the govorestat clinical trial. This news led to another decline in the stock price, dropping by $0.46 or 26.3%, to $1.29 per share by December 5, 2024.

Key Points of the Lawsuit

The filed complaint alleges that throughout the Class Period, the Company and its representatives made false or misleading statements and failed to disclose crucial information regarding its operations and risks. Specifically, they are accused of not adhering to trial protocols, which posed serious risks of FDA rejection for their data. Consequently, the positive claims made by the Defendants about the Company were misleading and lacked a reasonable basis.

Investors who purchased or acquired Applied Therapeutics securities during the Class Period have until February 18, 2025 to request the Court to appoint them as lead plaintiff if they meet specific legal criteria.

How to Get Involved

For more information about this class action or if you have questions regarding your rights, you can contact:

Law Offices of Howard G. Smith,

3070 Bristol Pike, Suite 112,

Bensalem, Pennsylvania 19020,

Telephone: (215) 638-4847

Email: howardsmith@howardsmithlaw.com,

Website: www.howardsmithlaw.com.

You do not need to take immediate action to be a member of this class action. You may choose to retain legal counsel or remain an absent member of the class.

This announcement may be considered Attorney Advertising in certain jurisdictions according to law and ethical guidelines.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250103109464/en/