Class Action Announcement for uniQure N.V. Investors: A Securities Fraud Class Action Lawsuit Was Filed Against uniQure N.V.

Core Viewpoint - Kessler Topaz Meltzer & Check, LLP has filed a securities fraud class action lawsuit against uniQure N.V. on behalf of investors who purchased shares during a specified class period, alleging that the company made materially false and misleading statements regarding its drug candidate AMT-130 and its regulatory prospects with the FDA [1][11]. Company Overview - uniQure N.V. is a biotechnology company focused on developing gene therapies for rare diseases, including Huntington's disease (HD) [3]. - The company's leading drug candidate, AMT-130, aims to slow the progression of HD, a fatal inherited disorder with no existing cure [4]. Clinical Trials and FDA Interaction - uniQure completed patient enrollment for two ongoing Phase I/II clinical trials for AMT-130, known as the Pivotal Study, in March 2022 [4]. - The FDA had previously agreed that the Pivotal Study would not include a placebo comparator, allowing results to be compared to an external historical dataset, ENROLL-HD, for potential BLA submission [5]. Investor Communication and Stock Performance - On September 24, 2025, uniQure announced topline results from the Pivotal Study, leading to a significant increase in share price from $13.66 to $47.50, a nearly 250% rise [7][8]. - By October 29, 2025, shares were trading above $70.00, and the company raised approximately $345 million through a public offering shortly after the positive study results [9]. Allegations of Misrepresentation - The lawsuit alleges that uniQure misrepresented the FDA's approval of the Pivotal Study design and downplayed the likelihood of delays in the BLA timeline, leading to inflated stock prices based on misleading information [11]. - On November 3, 2025, uniQure disclosed that the FDA no longer agreed that the study data was adequate for BLA submission, resulting in a stock price drop of over 49% [10]. Legal Process for Investors - Investors who acquired uniQure shares during the class period may seek to be appointed as lead plaintiffs by April 13, 2026, to represent the class in the lawsuit [2][12].