uniQure Faces Securities Fraud Lawsuit
Multiple law firms, including The Schall Law Firm and Rosen Law Firm, have announced a class-action lawsuit against gene therapy company uniQure N.V. The suit alleges violations of the Securities Exchange Act on behalf of investors who purchased shares between September and October 2025.
- The lawsuit centers on uniQure's lead gene therapy candidate, AMT-130, which is being developed to treat Huntington's disease, a fatal genetic disorder with no approved cure or treatments to slow its progression. - Allegations state the company misrepresented its alignment with the U.S. Food and Drug Administration (FDA) regarding the clinical trial design for AMT-130. Specifically, the suit claims uniQure failed to disclose that the FDA had not fully approved its plan to use an external historical data set as a comparator for its Pivotal Study. - The class period follows uniQure's September 24, 2025, announcement of positive topline results from its Phase I/II study, which claimed AMT-130 showed a 75% slowing of disease progression. This news caused the company's stock to surge nearly 250% in one day, from a close of $13.66 to $47.50 per share. - On November 3, 2025, uniQure revealed a significant regulatory setback, disclosing that the FDA no longer agreed the existing study data was adequate to support a Biologics License Application (BLA) submission. - Following the November disclosure about the FDA's position, uniQure's stock price plummeted by more than 49%, dropping from $67.69 per share on October 31, 2025, to $34.29 per share on November 3, 2025. - The lawsuit, filed in the Southern District of New York, names uniQure and certain executives as defendants, alleging they downplayed the likelihood of a delay in the BLA submission timeline. - Investors seeking to be appointed as lead plaintiff in the class action have a deadline of April 13, 2026.
