Faruqi & Faruqi Investigates Investors' Claims Against Applied Therapeutics Amid FDA Regulatory Setbacks

Investor Alert: Legal Investigation by Faruqi & Faruqi

Faruqi & Faruqi, LLP, a prominent law firm specializing in securities litigation, is currently investigating potential claims on behalf of investors of Applied Therapeutics, Inc. This notification acts as a call for all individuals who may have faced losses concerning the company's securities from January 3, 2024, through December 2, 2024. If you are among those affected, you are encouraged to contact Partner Josh Wilson to discuss your legal rights and options for involvement in a federal securities class action against Applied Therapeutics.

Background of Investigation

On November 27, 2024, Applied Therapeutics released a press statement revealing that the U.S. Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for govorestat, a novel aldose reductase inhibitor intended for the treatment of Classic Galactosemia. The FDA's determination was based on identified deficiencies during its review, leading to significant stock price declines as investors digested these unfavorable regulatory developments.

The report not only highlighted the regulatory hurdles facing the company but also indicated deeper issues within the Phase III INSPIRE trial. Among these were allegations of misleading statements made by the company and its executives, suggesting a more favorable outlook than reality substantiated. These disclosures included serious claims about electronic data capture problems and a dosing error during the trial's dose-escalation phase, which were allegedly concealed from the investing public. Such actions have raised concerns about compliance with federal securities laws, paving the way for potential litigation.

Stock Market Reactions

Following the FDA's announcement, Applied Therapeutics' share price dropped by $1.64 (16.06%) to close at $8.57 immediately on November 27, 2024. Subsequently, a further drop was observed on December 4, 2024, when the FDA released a Warning Letter indicating that Applied Therapeutics was aware of crucial issues in its data submissions as early as May 2024. This revelation led to another significant dip in share valuation, with a decline of $0.31 (18.34%) to $1.38. Such volatility has prompted the firm to look into potential claims for damages suffered by investors through the alleged misrepresentation of the company's clinical trial progress and the subsequent fallout from regulatory actions.

Class Action Filing and Opportunities for Investors

As the investigation progresses, Faruqi & Faruqi reminds all affected investors that the deadline to apply for the role of lead plaintiff in the pending federal securities class action lawsuit against Applied Therapeutics is February 18, 2025. Interested parties can still join the lawsuit, irrespective of whether they opt to take on the lead plaintiff role, which involves directing the litigation efforts. This lead role is typically occupied by the investor with the largest financial interest who is also representative of the broader class of impacted investors.

Potential plaintiffs and those with additional insights regarding the unlawful conduct involving Applied Therapeutics are urged to reach out to the firm. This includes whistleblowers and former employees who may possess valuable information. For further details, visit the firm's website at www.faruqilaw.com/APLT or connect directly with Josh Wilson at 877-247-4292.

Conclusion

Faruqi & Faruqi, LLP aims to ensure that all investors of Applied Therapeutics are informed of their legal rights following these unsettling disclosures and the ensuing stock market repercussions. As regulatory scrutiny continues and developments unfold, the firm remains committed to representing the interests of investors who may have incurred losses as a result of the company's alleged misrepresentations. Following this situation closely could prove essential for those holding or having held shares in Applied Therapeutics. Therefore, the legal community invites all affected stakeholders to actively participate and seek justice through appropriate channels.

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