APLT CLASS ACTION UPDATE: Applied Therapeutics Investors are Reminded to Contact BFA Law before Imminent February 18 Deadline

New York, New York--(Newsfile Corp. - February 11, 2025) - Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Applied Therapeutics, Inc. (NASDAQ: APLT) and certain of the Company's senior executives for potential violations of the federal securities laws.

If you 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 ask the Court to 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 Applied Therapeutics securities. 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 Lawsuit About?

Applied Therapeutics is a clinical-stage 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 central nervous system penetrant Aldose Reductase Inhibitor for the treatment of CNS rare metabolic diseases, including Galactosemia.

During the relevant period, the Company stated that its New Drug Applications submitted to regulators for govorestat were "supported by rapid and sustained reduction in galactitol, which resulted in a meaningful benefit on clinical outcomes across pediatric patients, alongside a favorable safety profile." Applied Therapeutics also assured investors that its tests were "performed properly" and that the Company "felt good about the quality of the data," stating that it "took really extensive steps" and "actually videotaped" and had "master trainers" review all of the performances of the 10-meter walk-run test-the primary endpoint of the Company's Phase III INSPIRE study for govorestat.

The Stock Declines as the Truth is Revealed

On November 27, 2024, Applied Therapeutics issued a press release stating that the FDA issued a Complete Response Letter for the NDA for govorestat. The Complete 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."