New York, New York–(Newsfile Corp. – December 21, 2024) – A Leading Securities Law Firm Blishmar Fonte & Old LLP Announces filing of lawsuit against Applied Therapeutics, Inc. (NASDAQ: NASDAQ:) and certain of the company's senior executives for potential violations of the federal securities laws.
If you have invested in applied treatments, we encourage you to obtain additional information by visiting the website https://www.bfalaw.com/cases-investigations/applied-therapeutics-inc.
Investors have until February 18, 2025, to ask the court to appoint them to lead the case. The Complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors in applied therapeutic securities. The case is pending in the U.S. District Court for the Southern District of New York Alexandru v. Applied Therapeutics, Inc., et al.No. 24-cv-09715.
What is the subject of the lawsuit?
Applied Therapeutics is a clinical-stage biopharmaceutical company specializing in the development of novel drug candidates against approved molecular targets in rare diseases. The company's lead drug candidate, govorestat, is a central nervous system penetrating Aldose reductase inhibitor for the treatment of rare metabolic diseases of the central nervous system, including galactosemia.
During the relevant period, the company stated that its new drug applications submitted to regulators for govorstat “were supported by rapid and sustained reduction in galactitol, which resulted in a significant benefit on clinical outcomes among pediatric patients, coupled with a favorable safety profile.” Applied Therapeutics also assured investors that its tests were “done properly” and that the company “felt good about the quality of the data,” noting that it “took really extensive steps” and “actually videotaped it” and asked “key trainers” to review all the data. . of 10-meter walk and run test performance – the primary endpoint of the company's phase 3 INSPIRE study for govorestat.
Stocks decline as truth is revealed
On November 27, 2024, Applied Therapeutics issued a press release stating that the FDA had issued a complete NDA response letter for govorestat. The full response letter stated that the FDA completed its review of the application and determined that it was unable to approve the NDA due to “deficiencies in the clinical application.”
This news caused Applied Therapeutics' stock price to fall more than 80% over multiple trading days, from a closing price of $10.21 per share on November 26, 2024 to a closing price of $1.75 per share on December 2, 2024.
Subsequently, on December 2, 2024, Applied Therapeutics revealed that it had received a warning letter from the FDA related to the govorestat study discussing “issues with electronic data capture” and “a dosing error in the dose-escalation phase of the study resulting in slightly lower levels It is targeted in a limited number of patients.
This news caused Applied Therapeutics' stock price to fall more than 26% over multiple trading days, from a closing price of $1.75 per share on December 2, 2024 to a closing price of $1.29 per share on December 5, 2024.
Click here for more information: https://www.bfalaw.com/cases-investigations/applied-therapeutics-inc.
What can you do?
If you invest in Applied Therapies, you may have legal options and we encourage you to provide your information to the Company.
All representation is done on a contingency fee basis, and there is no cost to you. Shareholders bear no responsibility for any court costs or litigation expenses. The Company will seek court approval for any potential fees and expenses.
Submit your information by visiting:
https://www.bfalaw.com/cases-investigations/applied-therapeutics-inc
Or call:
Why Blichmar Fonti & Old Co., Ltd.?
Bleichmar Fonti & Auld LLP is a leading international law firm that represents plaintiffs in securities class actions and shareholder lawsuits. It is ranked a Top 5 Law Firm for Plaintiffs by ISS SCAS in 2023 and its attorneys have been named Titans of the Plaintiffs' Bar by Law360 and SuperLawyers by Thompson Reuters. Among its recent notable successes, BFA has recovered over $900 million in value from Tesla's (NASDAQ:) board (pending court approval), as well as $420 million from Teva Pharmaceuticals (NYSE:) Ind. . Ltd.
For more information about BFA and its attorneys, please visit https://www.bfalaw.com.
https://www.bfalaw.com/cases-investigations/applied-therapeutics-inc
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To view the source version of this press release, please visit https://www.newsfilecorp.com/release/234751
