Core Viewpoint - A class action lawsuit has been filed against Applied Therapeutics, Inc. for alleged violations of federal securities laws during the specified class period [1][2]. Class Definition - The lawsuit seeks damages for all individuals and entities that purchased or acquired Applied Therapeutics securities between January 3, 2024, and December 2, 2024 [2]. Case Details - The Complaint alleges that during the class period, the defendants made false or misleading statements and failed to disclose critical information regarding the New Drug Application (NDA) for govorestat, including deficiencies that would prevent FDA approval and insufficient clinical data to demonstrate efficacy or safety [3]. Next Steps - Investors who suffered losses in Applied Therapeutics have until February 18, 2025, to request to be appointed as lead plaintiff in the case [4]. Cost Structure - The law firm operates on a contingency fee basis, meaning they will only seek reimbursement for expenses and attorney fees if the case is successful [5]. Firm Background - Bronstein, Gewirtz & Grossman, LLC is a nationally recognized law firm that has recovered hundreds of millions of dollars for investors in securities fraud class actions [6].

Core Viewpoint - The article discusses a class action lawsuit against Applied Therapeutics, Inc. for alleged violations of the Securities Exchange Act of 1934, focusing on misleading statements regarding the company's drug application process and subsequent FDA responses [1][4][5]. Group 1: Lawsuit Details - The class action lawsuit is titled Alexandru v. Applied Therapeutics, Inc., and it involves purchasers of Applied Therapeutics securities from January 3, 2024, to December 2, 2024 [1]. - The lawsuit alleges that Applied Therapeutics and its executives made false statements and failed to disclose adherence issues with trial protocols, which posed a risk of FDA rejection of their New Drug Application (NDA) for govorestat [4][5]. - On November 27, 2024, the FDA issued a Complete Response Letter indicating that the NDA could not be approved in its current form due to deficiencies, leading to an over 80% drop in stock price over three trading sessions [5]. - On December 2, 2024, Applied Therapeutics disclosed receiving a warning from the FDA regarding electronic data capture issues and a dosing error, resulting in a further decline of over 26% in stock price over three trading sessions [6]. Group 2: Lead Plaintiff Process - The Private Securities Litigation Reform Act of 1995 allows any investor who purchased Applied Therapeutics securities during the class period to seek appointment as lead plaintiff, representing the interests of the class [7]. - The lead plaintiff is typically the investor with the greatest financial interest and must be typical and adequate of the class [7]. Group 3: Company Background - Applied Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel drug candidates for rare diseases [3]. - Robbins Geller Rudman & Dowd LLP, the law firm handling the case, is recognized for its success in securities fraud cases, having recovered $6.6 billion for investors in such cases [8].

ATLANTA, Dec. 18, 2024 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed against Applied Therapeutics, Inc. (“Applied Therapeutics” or “the Company”) (NASDAQ: APLT). The lawsuit alleges that Defendants made materially false or misleading statements and/or concealed 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. If you bought shares of A ...

NEW YORK, Dec. 2, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Applied Therapeutics, Inc. ("Applied Therapeutics" or the "Company") (NASDAQ: APLT). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.The investigation concerns whether Applied Therapeutics and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the clas ...

Key TakeawaysApplied Therapeutics' application for a treatment of a rare metabolic disease was rejected by the Food and Drug Administration.The FDA said the drug, govorestat for galactosemia, had "deficiencies in the clinical application."The news sent shares of Applied Therapeutics plunging 75% Friday morning. Applied Therapeutics (APLT) shares cratered Friday as the biopharmaceutical firm reported that the Food and Drug Administration (FDA) rejected its application for its experimental treatment for a rar ...

On Wednesday, Applied Therapeutics, Inc APLT received an FDA Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat for Classic Galactosemia.Galactosemia is a rare genetic metabolic disease resulting in an inability to metabolize the simple sugar galactose. When not appropriately metabolized, galactose is converted to the toxic metabolite, galactitol, which causes neurological complications.Also Read: Applied Therapeutics Stock Soars As FDA Scraps Panel Meeting For Its Inherited Me ...

Applied Therapeutics (APLT) announced that the FDA has issued a Complete Response Letter (CRL) for the new drug application (NDA) seeking approval for APLT’s lead candidate, govorestat, to treat classic galactosemia. The CRL stated that the FDA has reviewed the application and cannot approve the NDA in its current form due to deficiencies in the clinical study results submitted in support of the application.Applied Therapeutics is evaluating the FDA's feedback. It intends to promptly request a meeting to di ...

NEW YORK, Nov. 27, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced 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. The CRL indicates that the FDA completed its r ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ | --- | --- | |----------------------------------------------------------------------------|------------- ...

Exhibit 99.1 Applied Therapeutics Reports Third Quarter 2024 Financial Results - NDA and MAA for govorestat for treatment of Classic Galactosemia under FDA Priority Review and EMA review; PDUFA target action date of November 28, 2024, and EMA decision expected in Q1 2025 - NDA submission for govorestat for the treatment of SORD Deficiency under Accelerated Approval expected in early Q1 2025 NEW YORK, November 7, 2024 – Applied Therapeutics, Inc. (Nasdaq: APLT) (the "Company"), a clinical-stage biopharmaceut ...