LOS ANGELES–(BUSINESS WIRE)–The DJS Law Group announces that it is investigating claims on behalf of investors of uniQure N.V. (“uniQure” or “the Company”) (NASDAQ: QURE) for violations of the securities laws.
INVESTIGATION DETAILS: The investigation focuses on whether the Company issued misleading statements and/or failed to disclose information pertinent to investors. On November 3, 2025, uniQure issued a press release concerned a pre-Biologics License Application (BLA) meeting with the FDA about AMT-130, its gene therapy for Huntington’s disease (HD). According to the Company, it “believes that the FDA currently no longer agrees that data from the Phase I/II studies of AMT-130 in comparison to an external control, as per the prespecified protocols and statistical analysis plans shared with the FDA in advance of the analyses, may be adequate to provide the primary evidence in support of a BLA submission.” Based on this news, shares of uniQure fell by more than 60% when the market opened on November 3, 2025.
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Contacts
David J. Schwartz
DJS Law Group
274 White Plains Road, Suite 1
Eastchester, NY 10709
Phone: 914-206-9742
Email: [email protected]
