NEW YORK, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the Southern District of New York on behalf of all persons or entities 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”). The Complaint alleges that on November 27, 2024, Defendant ...

NEW YORK, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law firm, notifies investors that a class action lawsuit has been filed against Applied Therapeutics, Inc. (“Applied Therapeutics” or “the Company”) (NASDAQ: APLT) and certain of its officers. Class Definition This lawsuit seeks to recover damages against Defendants for alleged violations of the federal securities laws on behalf of all persons and entities that purchased or otherwi ...

SAN DIEGO, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Applied Therapeutics, Inc. (NASDAQ: APLT) securities between January 3, 2024 and December 2, 2024, inclusive (the “Class Period”), have until February 18, 2025 to seek appointment as lead plaintiff of the Applied Therapeutics class action lawsuit. Captioned Alexandru v. Applied Therapeutics, Inc., No. 24-cv-09715 (S.D.N.Y.), the Applied Therapeutics class action lawsuit charges Applied The ...

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 ______________ | --- | --- | |----------------------------------------------------------------------------|------------- ...