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APLT.US
id: 1432
Applied Therapeutics (APLT) Clinical Trial Misrepresentation Case
S.D. New York
Court1:24-cv-09715
Case number01/03/2024
Class period Start12/02/2024
Class period End02/17/2025
Lead Plaintiff motion deadline- $APLT investors filed a lawsuit against Applied Therapeutics for misleading them about clinical trial data and the regulatory approval process for its lead drug.
- On November 27, 2024, Applied Therapeutics revealed that the FDA had issued a Complete Response Letter. Following this news, $APLT stock dropped over 80%.
Case Details:
Between January 3, 2024, and December 2, 2024, Applied Therapeutics made several optimistic statements about the clinical trial data and regulatory progress for Govorestat, its drug candidate for the treatment of galactosemia.
On February 15, 2024, the company announced positive results from its Phase III trial, noting significant improvements in patient outcomes and key biomarkers.
However, on November 27, 2024, the FDA issued a Complete Response Letter, pointing out serious deficiencies in the New Drug Application for Govorestat, including incomplete data and protocol inconsistencies.
On December 2, 2024, Applied Therapeutics received a warning letter from the FDA for not adequately addressing past trial issues. This raised concerns about the gap between the company’s public claims and the reality of its clinical data and regulatory compliance.
Following these announcements, $APLT plummeted by over 80%.
Based on these events, $APLT investors filed a lawsuit against Applied Therapeutics, claiming the company:
- It misled investors about the quality of its clinical trial data and regulatory readiness.
- It failed to disclose deficiencies in its clinical practices, including trial data capture and protocol errors.
Investors believe Applied Therapeutics misrepresented its clinical trial results and regulatory progress for Govorestat.
Case Status
Lead Plaintiff Submission
Alleged Offence
Mismanagement,
Misleading Statements
Suspected Party
Directors,
Management
Security Type
Stocks
Trade Direction
Long
Shock Event Date
11/28/2024
Filing date
12/17/2024
Lead Plaintiff Deadline
02/17/2025