Latest news with #AppliedTherapeutics'
Associated Press
18-02-2025
- Business
- Associated Press
FINAL DEADLINE ALERT: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Applied Therapeutics
Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Applied Therapeutics, Inc. ('Applied Therapeutics' or the 'Company') (NASDAQ: APLT) and reminds investors of the February 18, 2025 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The firm has recovered hundreds of millions of dollars for investors since its founding in 1995. See As detailed below, the complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose that defendants provided positive statements to investors while, at the same time, disseminating false and materially misleading statements and/or concealing material adverse facts concerning the true state of Applied Therapeutics' Phase III INSPIRE trial; notably, electronic data capture issues and a dosing error in the dose-escalation phase of the study. Such statements absent these material facts caused Plaintiff and other shareholders to purchase Applied Therapeutics' securities at artificially inflated prices. 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 3, 2024, the FDA posted on its website a Warning Letter to Applied Therapeutics, the contents of which indicated that the Company was aware at least as early as May 2024 that the FDA had identified significant issues in the govorestat NDA. On this news, Applied Therapeutics' stock price fell $0.31 per share, or 18.34%, to close at $1.38 per share on December 4, 2024. The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not. Faruqi & Faruqi, LLP also encourages anyone with information regarding Applied Therapeutics' conduct to contact the firm, including whistleblowers, former employees, shareholders and others. To learn more about the Applied Therapeutics class action, go to or call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP ( Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner. Josh Wilson 877-247-4292 or 212-983-9330 (Ext. 1310) SOURCE: Faruqi & Faruqi, LLP Copyright Business Wire 2025. PUB: 02/18/2025 11:53 AM/DISC: 02/18/2025 11:53 AM
Associated Press
27-01-2025
- Business
- Associated Press
Deadline Alert: Applied Therapeutics, Inc. (APLT) Investors Who Lost Money Urged To Contact Glancy Prongay & Murray LLP About Securities Fraud Lawsuit
LOS ANGELES, Jan. 27, 2025 (GLOBE NEWSWIRE) -- Glancy Prongay & Murray LLP reminds investors of the upcoming February 18, 2025 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who purchased or otherwise 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 SUFFERED A LOSS ON YOUR APPLIED THERAPEUTICS INVESTMENTS, TO INQUIRE ABOUT POTENTIALLY PURSUING CLAIMS TO RECOVER YOUR LOSS UNDER THE FEDERAL SECURITIES LAWS. CLICK HERE 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 during the Class Period, you may move the Court no later than February 18, 2025 to request appointment as lead plaintiff in this putative class action lawsuit. Contact Us To Participate or Learn More: If you wish to learn more about this action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact us: Charles Linehan, Esq., Glancy Prongay & Murray LLP, 1925 Century Park East, Suite 2100, Los Angeles California 90067 Email: [email protected] Telephone: 310-201-9150, Toll-Free: 888-773-9224 Visit our website at Follow us for updates on LinkedIn, Twitter, or Facebook. 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. Contact Us: Glancy Prongay & Murray LLP, 1925 Century Park East, Suite 2100 Los Angeles, CA 90067 Charles Linehan Toll-Free: 888-773-9224
