Class Action Lawsuit Filed Against uniQure Over FDA Approval Disclosures

GlobeNewswire Inc.GlobeNewswire Inc.
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Key Takeaway

uniQure faces class action lawsuit alleging misleading FDA approval statements and understated BLA timeline risks. Investors who purchased securities between September-October 2025 may be eligible to participate.

Class Action Lawsuit Filed Against uniQure Over FDA Approval Disclosures

A class action lawsuit has been initiated against uniQure N.V., alleging that company officials made materially false and misleading statements regarding FDA approval prospects for their Pivotal Study design and understated the risk of delays to their Biologics License Application (BLA) timeline. The litigation targets the period between September 24, 2025, and October 31, 2025, during which investors are alleged to have purchased company securities based on incomplete or inaccurate information.

The lawsuit, brought by the firm Bronstein, Gewirtz & Grossman LLC, seeks to represent shareholders who suffered losses during the relevant trading window. Investors who purchased uniQure securities during this timeframe may be eligible to participate in the class action, with the lead plaintiff deadline set for April 13, 2026.

The case centers on allegations that the company's public disclosures failed to adequately communicate regulatory risks and potential delays to its BLA submission timeline. Such class actions typically examine whether companies met their obligations to provide investors with accurate, material information necessary for making informed investment decisions.

Source: GlobeNewswire Inc.

Back to newsPublished Feb 19

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