According to the lawsuit, defendants misrepresented and/or failed to disclose that:
- the design of uniQure’s Pivotal Study (a study of uniQure’s leading drug candidate in patients with Huntington’s Disease)— including comparison of the Pivotal Study results to the ENROLL-HD external historical data set—was not fully approved by the U.S. Food and Drug Administration (the “FDA”);
- 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
- as a result, defendants’ statements about uniQure’s business, operations, and prospects lacked a reasonable basis.
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