New York, New York–(Newsfile Corp. – January 18, 2025) – Leading Securities Law Firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed 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 Therapeutics, you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/applied-therapeutics-inc.
Investors have until February 18, 2025 to request that the Court be appointed 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 the securities of Applied Therapeutics. The case is pending in the U.S. District Court for the Southern District of New York and is captioned Alexandru v. Applied Therapeutics, Inc., et al.No. 24-cv-09715.
What is the trial about?
Applied Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel drug candidates against validated 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 CNS metabolic diseases, including galactosemia.
During the relevant period, the Company said its new drug applications submitted to regulators for govorestat were “supported by rapid and sustained reduction of galactitol, which resulted in a significant benefit on clinical outcomes in pediatric patients, as well as a favorable safety profile.” Applied Therapeutics also assured investors that its testing was “performed properly” and that the company “felt pleased with the quality of the data,” saying it “took very thorough measurements” and “actually videotaped » and had “master trainers” review all the tests. performance on the 10-meter walk-run test, the primary endpoint of the Company’s Phase III INSPIRE study for govorestat.
Stock falls as truth is revealed
On November 27, 2024, Applied Therapeutics issued a press release stating that the FDA has issued a comprehensive response letter to the NDA for govorestat. The comprehensive response letter stated that the FDA had completed its review of the application and determined that it was unable to approve the NDA due to “deficiencies in clinical application.”
This news caused Applied Therapeutics’ stock price to fall more than 80% over the course of several 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.
Then, on December 2, 2024, Applied Therapeutics revealed that it had received a warning letter from the FDA related to its govorestat study discussing “issues with electronic data capture” and “a dosing error in the dose escalation phase of the study resulting in levels slightly lower than targeted in a limited number of patients[.]”
This news caused Applied Therapeutics’ stock price to fall more than 26% over several 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 have invested in Applied Therapeutics, you may have legal options and we encourage you to submit your information to the company.
All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for legal costs or expenses related to litigation. The firm will seek court approval for any potential fees and expenses.
Submit your information by visiting:
https://www.bfalaw.com/cases-investigations/applied-therapeutics-inc
Why Bleichmar Fonti & Auld LLP?
Bleichmar Fonti & Auld LLP is a leading international law firm representing plaintiffs in securities class actions and shareholder disputes. It was named a Top 5 Plaintiffs’ Law Firm by ISS SCAS in 2023 and its attorneys were named Titans of the Plaintiffs’ Bar by Law360 and SuperLawyers by Thompson Reuters. Among its notable recent successes, BFA has collected more than $900 million from the board of directors of Tesla (NASDAQ:), Inc., as well as $420 million from Teva Pharmaceutical (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/237611
