Applied Therapeutics, Inc. Investors are being warned that the company is being sued for securities fraud and are being urged to contact BFA Law before an imminent court date Investing.com

(Newsfile Corp. – January 2, 2025) – A leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Applied Therapeutics, Inc. (NASDAQ: NASDAQ: ) and certain senior executives of the Company for possible violations of federal securities laws.

If you have invested in Applied Therapeutics, we encourage you to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/applied-therapeutics-inc.

Investors have until February 18, 2025 to ask the Court to be appointed to manage 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 securities of Applied Therapeutics. The case is pending in the US District Court for the Southern District of New York and is subtitled Alexandru v. Applied Therapeutics, Inc., et al.number 24-cv-09715.

What is the lawsuit about?

Applied Therapeutics is a clinical biopharmaceutical company specializing in the development of novel drug candidates against validated molecular targets in rare diseases. The company’s lead drug candidate, govorestat, is a CNS-penetrating aldose reductase inhibitor for the treatment of rare CNS metabolic diseases, including galactosemia.

During the relevant period, the Company stated that its New Drug Applications submitted to regulators for govestat were “supported by rapid and sustained reductions in galactitol, resulting in significant improvements in clinical outcomes in pediatric patients, with a favorable safety profile.” Applied Therapeutics also reassured investors that its tests were “done right” and that the company “feels good about the quality of the data,” saying it “took really extensive steps” and “actually recorded” and reviewed the “head coaches” all performance of the 10-meter walk and run test – the primary endpoints of the phase III INSPIRE study for gorestat.

The stock drops as the truth is revealed

On November 27, 2024, Applied Therapeutics issued a press release stating that the FDA had issued a complete response to the goverestat NDA. The Full 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.”

The news caused Applied Therapeutics’ stock price to drop 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.

Then, on December 2, 2024, Applied Therapeutics disclosed that it had received a warning letter from the FDA regarding its gorestat study that discussed “problems associated with electronic data collection” and “a dosing error in the dose-escalation phase of the study that resulted in some at lower than targeted levels in a limited number of patients[.]”

The news caused Applied Therapeutics’ stock price to drop 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 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, at no cost to you. Shareholders are not responsible for any court costs or litigation expenses. The Company will seek court approval for all potential fees and costs.

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 litigation. ISS SCAS named it a Top 5 Law Firm for Plaintiffs in 2023, Thompson Reuters named its attorneys Titans of the Plaintiff Bar Association, and Thompson Reuters SuperLawyers. Among its recent notable successes, BFA recovered over $900 million in value from Tesla (NASDAQ: ), Inc. board of directors (pending court approval), as well as $420 million from Teva Pharmaceutical (NYSE: ) Ind. Ltd.

For more information about BFA and its attorneys, visit https://www.bfalaw.com.

https://www.bfalaw.com/cases-investigations/applied-therapeutics-inc

Advertising of lawyers. Past results do not guarantee future results.

To view the original version of this press release, visit https://www.newsfilecorp.com/release/234761