Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38898 Applied Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 81-3405262 (State ...

Applied Therapeutics Reports Fourth Quarter and Year-end 2024 Financial Results "We remain focused on preparing for potential regulatory interactions regarding govorestat in both Classic Galactosemia and Sorbitol Dehydrogenase ("SORD") Deficiency," said Les Funtleyder, Interim CEO and CFO of Applied Therapeutics. "As we continue to optimize our strategy for our late-stage programs, we have also made key senior appointments across regulatory, medical and quality affairs functions to bolster our capabilities. ...

-  Appointed John H. Johnson as Executive Chairman; Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer; and Reena Thomas Colacot as Vice President and Head of Quality NEW YORK, April 14, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT) (the "Company"), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today reported financial results for the fourth quarter and full ye ...

The Company will make a subsequent announcement to disclose its fourth quarter and full-year 2024 earnings results once the filing date of its Form 10-K is confirmed. About Applied Therapeutics NEW YORK, March 31, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT) (the "Company"), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that it has filed a Form 12b- ...

Core Insights - Applied Therapeutics, Inc. has appointed Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer to lead the company's global regulatory strategy [1][3] - Dr. Baumgartner brings over 35 years of experience in drug development and has successfully led 12 New Drug Applications and marketing authorizations [2] - The company is focused on advancing its lead drug candidate, govorestat, for the treatment of rare diseases [4] Company Overview - Applied Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing novel drug candidates targeting rare diseases [4] - The lead drug candidate, govorestat, is an Aldose Reductase Inhibitor aimed at treating CNS rare metabolic diseases [4] Leadership Background - Dr. Baumgartner previously served as Senior Vice President of Global Regulatory Affairs at Ovid Therapeutics, overseeing multiple development functions [2] - He has held senior roles at Acorda Therapeutics, Purdue Pharma, AstraZeneca Pharmaceuticals, and Bristol-Myers Squibb [2]

RADNOR, Pa., Feb. 16, 2025 /PRNewswire/ -- The law firm of Kessler Topaz Meltzer & Check, LLP (www.ktmc.com) informs investors that a securities class action lawsuit has been filed in the United States District Court for the Southern District of New York against Applied Therapeutics, Inc. ("Applied Therapeutics") (NASDAQ: APLT) on behalf of those who purchased or otherwise acquired Applied Therapeutics securities between January 3, 2024, and December 2, 2024, inclusive (the "Class Period"). The lead plainti ...

NEW YORK, Feb. 14, 2025 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Applied Therapeutics, Inc. (NASDAQ: APLT) between January 3, 2024 and December 2, 2024, both dates inclusive (the “Class Period”), of the important February 18, 2025 lead plaintiff deadline. SO WHAT: If you purchased Applied Therapeutics securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a conti ...

Core Viewpoint - A class action securities lawsuit has been filed against Applied Therapeutics, Inc. due to alleged securities fraud affecting investors between January 3, 2024, and December 2, 2024 [1] Group 1: Case Details - On November 27, 2024, Applied Therapeutics announced it received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for govorestat, indicating deficiencies in the clinical application [2] - Following the CRL announcement, the stock price of Applied Therapeutics dropped from $10.21 per share on November 26, 2024, to $8.57 on November 27, 2024, and further declined to $2.03 on November 29, 2024, and $1.75 on December 2, 2024, marking a total decline of over 80% [2] - After disclosing a "warning letter" from the FDA regarding clinical trial issues on December 2, 2024, the stock price fell further to $1.69 on December 3, 2024, and continued to decline to $1.38 on December 4, 2024, and $1.29 on December 5, 2024 [2] Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until February 18, 2025, to request the Court to appoint them as lead plaintiff, although participation in any recovery does not require serving as a lead plaintiff [3] - Class members may be entitled to compensation without any out-of-pocket costs or fees [3] Group 3: Firm Background - Levi & Korsinsky, LLP has a history of securing hundreds of millions of dollars for shareholders and has been recognized as one of the top securities litigation firms in the United States for seven consecutive years [4]

Core Viewpoint - A securities class action lawsuit has been filed against Applied Therapeutics, Inc. for alleged misconduct related to its drug candidate, govorestat, during the Class Period from January 3, 2024, to December 2, 2024 [1][2]. Group 1: Lawsuit Details - The lawsuit was filed in the United States District Court for the Southern District of New York on behalf of investors who acquired Applied Therapeutics securities during the specified Class Period [1]. - The lead plaintiff deadline for the lawsuit is set for February 18, 2025 [1][3]. - The complaint alleges that the defendants made false or misleading statements and failed to disclose that Applied Therapeutics was not following trial protocols and good clinical practices, which posed a significant risk of FDA rejection of trial data [2]. Group 2: Lead Plaintiff Process - Investors in Applied Therapeutics can seek to be appointed as lead plaintiff representatives by the deadline of February 18, 2025, or choose to remain absent class members [3]. - The lead plaintiff will represent all class members in directing the litigation and is typically the investor or group of investors with the largest financial interest [3]. Group 3: Firm Background - Kessler Topaz Meltzer & Check, LLP is known for prosecuting class actions and has a reputation for recovering billions for victims of corporate misconduct [4]. - The firm aims to protect investors and others from fraud and negligence by businesses [4].

NEW YORK, Feb. 10, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Applied Therapeutics, Inc. (NASDAQ: APLT).Shareholders who purchased shares of APLT during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/applied-therapeutics-inc-loss-submission-form/?id=127836&from=4CLASS PERIOD: J ...