Applied Therapeutics faces securities lawsuit
Analysis based on 10 articles · First reported Jan 07, 2025 · Last updated Jan 17, 2025
The class action lawsuit against Applied Therapeutics, following the United States — Food and Drug Administration's rejection of its drug govorestat and subsequent warning letter, has led to a significant decline in Applied Therapeutics' stock price. This event highlights the risks associated with clinical-stage biopharmaceutical companies and the importance of regulatory approvals, potentially increasing investor scrutiny in the biotechnology sector.
Applied Therapeutics, a clinical-stage biopharmaceutical company, is facing a class action lawsuit filed by Bleichmar Fonti & Auld LLP on behalf of investors. The lawsuit alleges violations of federal securities laws after the United States — Food and Drug Administration issued a Complete Response Letter for Applied Therapeutics' lead drug candidate, govorestat, on November 27, 2024, citing 'deficiencies in the clinical application.' This news caused Applied Therapeutics' stock to plummet over 80%. Further, on December 2, 2024, Applied Therapeutics disclosed a warning letter from the United States — Food and Drug Administration detailing 'issues related to electronic data capture' and a 'dosing error' in the govorestat study, leading to an additional 26% stock drop. Investors have until February 18, 2025, to join the lawsuit, which is pending in the United States — United States District Court for the Northern District of California.
Set up alerts, explore entity relationships, search across thousands of events, and build custom intelligence feeds.
Open Dashboard