uniQure N.V. Class Action Lawsuit – QURE

The filed complaint alleges that uniQure N.V. made materially false and/or misleading statements 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 Biologics License Application (“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.