NEW YORK, Jan. 30, 2025 (GLOBE NEWSWIRE) -- The law firm of Kirby McInerney LLP reminds investors of the February 18, 2025, deadline to seek the role of lead plaintiff in a federal securities class action filed on behalf of investors who acquired Applied Therapeutics, Inc. (“Applied Therapeutics” or the “Company”) (NASDAQ:APLT) securities during the period from January 3, 2024, through December 2, 2024 (“the Class Period”). [LEARN MORE ABOUT THE CLASS ACTION] On November 27, 2024, Applied Therapeutics issu ...

Core Viewpoint - Applied Therapeutics, Inc. faced significant stock price declines following the issuance of a Complete Response Letter (CRL) from the FDA regarding its lead drug candidate, govorestat, indicating deficiencies in the clinical application [2]. Group 1: Stock Performance and Decline - On November 26, 2024, Applied Therapeutics' stock closed at $10.21 per share, but after the CRL announcement on November 27, it dropped to $8.57, marking an initial decline [2]. - The stock continued to fall dramatically, reaching $2.03 on November 29, 2024, and further declining to $1.75 by December 2, 2024, resulting in a total decline of over 80% from its pre-announcement price [2]. - Following the disclosure of a "warning letter" from the FDA 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: Legal Action and Shareholder Information - Shareholders who purchased shares during the class period from January 3, 2024, to December 2, 2024, are encouraged to contact the Gross Law Firm regarding potential lead plaintiff appointments [1][2]. - The deadline for shareholders to register for the class action is February 18, 2025, and there is no cost or obligation to participate [3]. - Once registered, shareholders will be enrolled in a portfolio monitoring software to receive updates throughout the case lifecycle [3].

RADNOR, Pa., Jan. 29, 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 ...

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses In Applied Therapeutics To Contact Him Directly To Discuss Their Options If you purchased or acquired securities in Applied Therapeutics January 3, 2024 and December 2, 2024 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] NEW YORK, Jan. 29, 2025 (GLOBE N ...

Core Viewpoint - A lawsuit has been filed against Applied Therapeutics, Inc. and certain senior executives for potential violations of federal securities laws, following significant stock price declines after negative FDA communications regarding their lead drug candidate, govorestat [1][2]. Company Overview - Applied Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel drug candidates for rare diseases, with its lead candidate being govorestat, aimed at treating CNS rare metabolic diseases like Galactosemia [3]. Regulatory Developments - The company claimed that its New Drug Applications for govorestat were supported by positive clinical data, including a rapid reduction in galactitol and a favorable safety profile [4]. - On November 27, 2024, the FDA issued a Complete Response Letter for the NDA for govorestat, citing deficiencies in the clinical application, leading to an over 80% drop in stock price from $10.21 to $1.75 within a week [5]. - Following this, on December 2, 2024, the company received a warning letter from the FDA regarding issues in the govorestat study, causing an additional decline of over 26% in stock price from $1.75 to $1.29 [6]. Legal Actions - Investors have until February 18, 2025, to seek appointment as lead plaintiffs in the case, which is currently pending in the U.S. District Court for the Southern District of New York [2]. - The lawsuit asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors in Applied Therapeutics securities [2]. Investor Information - Investors are encouraged to submit their information to the law firm representing the plaintiffs, with no upfront costs for shareholders [7]. - The law firm has a strong track record in securities class actions, having recovered significant amounts for other clients in the past [9].

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][3][4]. Company Overview - Applied Therapeutics, Inc. is a clinical-stage biopharmaceutical company that develops novel drug candidates targeting rare diseases [2]. Class Action Details - The class action lawsuit is titled Alexandru v. Applied Therapeutics, Inc., and it allows investors who purchased securities between January 3, 2024, and December 2, 2024, to seek lead plaintiff status by February 18, 2025 [1][6]. - The lawsuit alleges that the company and its executives made false statements and failed to disclose adherence issues with trial protocols, leading to a significant risk of FDA rejection of their New Drug Application (NDA) [3]. FDA Interactions - On November 27, 2024, the FDA issued a Complete Response Letter for the NDA for govorestat, indicating that the application could not be approved in its current form due to clinical application deficiencies. Following this announcement, Applied Therapeutics' stock price fell over 80% within three trading sessions [4]. - On December 2, 2024, the company disclosed receiving a warning from the FDA regarding issues with electronic data capture and a dosing error, resulting in a further stock price decline of over 26% in three trading sessions [5]. Legal Process - The Private Securities Litigation Reform Act of 1995 allows any investor who acquired Applied Therapeutics securities during the class period to seek lead plaintiff status, which involves directing the lawsuit on behalf of all class members [6]. Law Firm Background - Robbins Geller Rudman & Dowd LLP is a leading law firm in securities fraud cases, having recovered $6.6 billion for investors in class action cases, significantly more than any other firm in the last four years [7].

SAN DIEGO, Jan. 29, 2025 /PRNewswire/ -- Robbins LLP reminds investors that a class action was filed on behalf of all investors who purchased or otherwise acquired Applied Therapeutics, Inc. (NASDAQ: APLT) securities between January 3, 2024 and December 2, 2024. Applied Therapeutics is a clinical-stage biopharmaceutical company committed to the development of novel drug candidates against validated molecular targets in rare diseases.For more information, submit a form, email attorney Aaron Dumas, Jr., or gi ...

RADNOR, Pa., Jan. 27, 2025 (GLOBE NEWSWIRE) -- 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 pla ...

Core Viewpoint - The news highlights a class action lawsuit against Applied Therapeutics, Inc. due to significant stock price declines following the issuance of a Complete Response Letter (CRL) from the FDA regarding its lead drug candidate, govorestat [2][3]. Group 1: Company Overview - Applied Therapeutics, Inc. is facing legal action from shareholders who purchased shares during the class period from January 3, 2024, to December 2, 2024 [2]. - The company’s lead drug candidate, govorestat, received a CRL from the FDA on November 27, 2024, indicating that the application could not be approved in its current form due to clinical application deficiencies [2]. Group 2: Stock Price Impact - Following the CRL announcement, Applied Therapeutics' stock price 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, marking a total decline of over 80% [2]. - After the company disclosed a "warning letter" from the FDA on December 2, 2024, the stock price fell from $1.75 per share 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 3: Legal Proceedings - Shareholders are encouraged to register for the class action lawsuit, with a deadline set for February 18, 2025, to seek lead plaintiff status [3]. - The Gross Law Firm, which is handling the case, aims to protect the rights of investors who have suffered losses due to misleading statements or omissions by the company [4].

Lawsuit Overview - A securities class action lawsuit has been filed against Applied Therapeutics Inc (NASDAQ: APLT) in the United States District Court for the Southern District of New York [1] - The lawsuit is on behalf of investors who purchased or acquired Applied Therapeutics securities between January 3, 2024, and December 2, 2024 [1] - The lead plaintiff deadline is February 18, 2025 [1] Allegations - The complaint alleges that Applied Therapeutics made false and/or misleading statements and/or failed to disclose that the company was not adhering to trial protocol and good clinical practices for its drug candidate, govorestat [2] - This alleged misconduct created a severe risk that the trial data would be rejected by the FDA in the context of a New Drug Application [2] Lead Plaintiff Process - Applied Therapeutics investors may seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLP or other counsel by February 18, 2025 [3] - The lead plaintiff is typically the investor or small group of investors with the largest financial interest who are also adequate and typical of the proposed class of investors [3] - The lead plaintiff selects counsel to represent the lead plaintiff and the class, and these attorneys, if approved by the court, are lead or class counsel [3] Law Firm Information - Kessler Topaz Meltzer & Check, LLP is prosecuting the class action and encourages Applied Therapeutics investors who have suffered significant losses to contact the firm directly [4] - The firm has a global reputation for excellence and has recovered billions of dollars for victims of fraud and other corporate misconduct [4] - The complaint in this action was not filed by Kessler Topaz Meltzer & Check, LLP [4]