A securities class action has been filed against uniQure N.V. (QURE) on behalf of all persons and entities who purchased or otherwise acquired uniQure ordinary shares between September 24, 2025 through October 31, 2025. This case has been filed in the USDC – SDNY.
The complaint alleges that, throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts, about the Company’s business and operations. Specifically, Defendants misrepresented and/or failed to disclose that: (1) the design of uniQure’s Pivotal Study—including comparison of the Pivotal Study results to the ENROLL-HD external historical data set—was not fully approved by the FDA; (2) Defendants downplayed the likelihood that, despite purportedly highly successful results from the Pivotal Study, uniQure would have to delay its BLA timeline to perform additional studies to supplement its BLA submission; and (3) as a result, Defendants’ statements about the Company’s business, operations, and prospects lacked a reasonable basis.