NEW YORK, Dec. 20, 2024 -- Pomerantz LLP announces that a class action lawsuit has been filed against Applied Therapeutics, Inc. ("Applied Therapeutics" or the "Company") (NASDAQ: APLT). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
The class action concerns whether Applied Therapeutics and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
You have until February 18, 2025, to ask the Court to appoint you as Lead Plaintiff for the class if you are a shareholder who purchased or otherwise acquired DMC securities during the Class Period. A copy of the Complaint can be obtained at www.pomerantzlaw.com.
[Click here for information about joining the class action]
On November 27, 2024, Applied Therapeutics issued a press release announcing "that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of Classic Galactosemia." According to the Company, "[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 $1.64 per share, or 16.06%, to close at $8.57 per share on November 27, 2024.
Then, on December 2, 2024, Applied Therapeutics disclosed receipt of a "warning letter" from the FDA referring to the clinical trial issues underlying the CRL. According to the Company's description of the "warning letter," the FDA stated in pertinent part that: "The letter identified 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. The letter also refers to 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. Detailed records were maintained by the Company under FDA regulatory requirements, and this information was provided to FDA. The Company intends to respond within the permitted 15 business days to address these issues."
On this news, Applied Therapeutics' stock price fell $0.46 per share, or 26.29%, over the following three trading sessions, to close at $1.29 per share on December 5, 2024.
Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See www.pomlaw.com.
Attorney advertising. Prior results do not guarantee similar outcomes.
CONTACT:
Danielle Peyton
Pomerantz LLP
dpeyton@pomlaw.com
646-581-9980 ext. 7980
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