QURE Investor Alert: Consult Kessler Topaz Meltzer & Check, LLP regarding…

Investor Alert: Securities Fraud Lawsuit Filed Against uniQure N.V. (QURE)

Kessler Topaz Meltzer & Check, LLP recently announced the initiation of a securities fraud class action lawsuit against uniQure N.V. (NASDAQ: QURE). The lawsuit, titled Scocco v. uniQure N.V., et al., Case No. 1:26-cv-01124, was filed on behalf of investors who bought or traded uniQure ordinary shares between September 24, 2025, and October 31, 2025, encompassing the Class Period. Investors who fall within this category have until April 13, 2026, to seek the role of lead plaintiff for the class.

Medical Company accused of Securities Fraud Related to Drug Candidate AMT-130

uniQure N.V., a biotechnology firm specializing in gene therapies for rare conditions like Huntington’s disease (HD), has come under scrutiny. The company’s premier drug candidate, AMT-130, is a revolutionary gene therapy aimed at slowing down the advancement of HD. HD is an inherited illness that leads to the degeneration of nerve cells in the brain, resulting in movement and cognitive issues along with psychiatric manifestations. Unfortunately, there exists no cure or approved method to halt the progression of this fatal disorder. AMT-130 is one of the few drugs currently under examination intended to impede the advancement of HD.

Key Allegations in the Securities Fraud Class Action Lawsuit

The lawsuit centers on allegations concerning uniQure’s communication with investors regarding the progress of its clinical trials for AMT-130. The US Food and Drug Administration (FDA) purportedly reached an agreement with uniQure that the results of the Pivotal Study would not include a placebo group. Instead, the outcomes of the study could be juxtaposed against historical data, specifically the Enroll-HD dataset. uniQure believed that this analysis could serve as the foundation for a Biologics License Application (BLA) submission to the FDA for the approval of AMT-130 for HD patients.

CEO’s Assurances Trigger Allegations

During calls with investors in June and July 2025, uniQure’s CEO, Matthew Kapusta, purported to be in alignment with the FDA regarding the trial’s design and progress. The Class Period officially commenced on September 24, 2025, following the release of the topline results of the Pivotal Study. uniQure emphasized that AMT-130 had shown a reduction in cerebrospinal neurofilament light protein, which the company described as a recognized biomarker for neurodegeneration. This led investors to believe that AMT-130 was effective in slowing neurodegeneration in HD patients and that accelerated approval from the FDA was imminent.

Market Reaction and Subsequent Lawsuit

In response to uniQure’s positive statements, the company’s stock price surged significantly. By October 29, 2025, uniQure’s shares were trading above $70.00 per share, a substantial increase from previous values. However, allegations have since surfaced regarding the accuracy and transparency of the information shared by uniQure with investors during the Class Period. As a result, a securities fraud class action lawsuit has been filed to investigate these claims and hold the company accountable for any potential discrepancies. Investors affected by these events are urged to take action by the specified deadline to participate in the lawsuit.