Investigations
Applied Therapeutics, Inc.
Overview
Overview
- Deadline:
- Feb 18, 2025
| Company Name: | Company Name: Applied Therapeutics, Inc. |
| Stock Symbol: | Stock Symbol: APLT |
Applied Therapeutics, Inc. (NASDAQ: APLT): Applied Therapeutics, Inc. (“Applied Therapeutics” or the “Company”) and certain of the Company’s senior executives have been sued for violations of the federal securities laws. 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.
If you incurred losses on your investments in Applied Therapeutics, you are encouraged to submit your information.
Why was Applied Therapeutics Sued for Securities Fraud?
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.” This news caused the price of Applied Therapeutics stock to fall more than 80% over the course of 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 revealed that it received a warning letter from the FDA relating to its govorestat study discussing “issues related to electronic data capture” and “a dosing error in the dose-escalation phase of the study resulting in slightly lower levels than targeted in a limited number of patients[.]” This news caused the price of Applied Therapeutics stock to fall more than 26% over the course of 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.
What are my Rights?
If you purchased or otherwise acquired Applied Therapeutics securities, you may ask the Court no later than February 18, 2025, which is the first business day after 60 days from the date of the publication of notice of pendency of the action, to appoint you as Lead Plaintiff through counsel of your choice. To be a member of the Class, you need not take any action at this time. The ability to share in any potential future recovery is not dependent on serving as Lead Plaintiff.
If you incurred losses on your investments in Applied Therapeutics, you are encouraged to submit your information to speak with an attorney about your rights.
You can also contact:
Ross Shikowitz
ross@bfalaw.com
212-789-3619
All representation is on a contingency fee basis. Shareholders are not responsible for any court costs or expenses of litigation. The Firm will seek court approval for any potential fees and expenses.
Why Bleichmar Fonti & Auld LLP?
BFA is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It was named among the Top 5 plaintiff law firms 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 recovered over $900 million in value from Tesla, Inc.’s Board of Directors (pending court approval), as well as $420 million from Teva Pharmaceutical Ind. Ltd.
Attorney advertising. Past results do not guarantee future outcomes.
If you incurred losses on your investments in Applied Therapeutics, you are encouraged to submit your information.
Why was Applied Therapeutics Sued for Securities Fraud?
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.” This news caused the price of Applied Therapeutics stock to fall more than 80% over the course of 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 revealed that it received a warning letter from the FDA relating to its govorestat study discussing “issues related to electronic data capture” and “a dosing error in the dose-escalation phase of the study resulting in slightly lower levels than targeted in a limited number of patients[.]” This news caused the price of Applied Therapeutics stock to fall more than 26% over the course of 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.
What are my Rights?
If you purchased or otherwise acquired Applied Therapeutics securities, you may ask the Court no later than February 18, 2025, which is the first business day after 60 days from the date of the publication of notice of pendency of the action, to appoint you as Lead Plaintiff through counsel of your choice. To be a member of the Class, you need not take any action at this time. The ability to share in any potential future recovery is not dependent on serving as Lead Plaintiff.
If you incurred losses on your investments in Applied Therapeutics, you are encouraged to submit your information to speak with an attorney about your rights.
You can also contact:
Ross Shikowitz
ross@bfalaw.com
212-789-3619
All representation is on a contingency fee basis. Shareholders are not responsible for any court costs or expenses of litigation. The Firm will seek court approval for any potential fees and expenses.
Why Bleichmar Fonti & Auld LLP?
BFA is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It was named among the Top 5 plaintiff law firms 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 recovered over $900 million in value from Tesla, Inc.’s Board of Directors (pending court approval), as well as $420 million from Teva Pharmaceutical Ind. Ltd.
Attorney advertising. Past results do not guarantee future outcomes.