uniQure(US:QURE) Globenewswire·2026-02-11 22:27Core 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 AMT-130 and its regulatory approval process [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 genetic 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 [8]. - By October 29, 2025, shares were trading above $70.00, prompting the company to offer over 5.7 million shares to capitalize on the increased valuation, generating approximately $345 million [9]. Disclosure of Regulatory Challenges - On November 3, 2025, uniQure disclosed that the FDA no longer agreed that the data from the Pivotal Study would be adequate for BLA submission, leading to a sharp decline in share price by over 49% [10]. Allegations in the Lawsuit - The lawsuit alleges that uniQure misrepresented the approval status of the Pivotal Study design and downplayed the likelihood of delays in the BLA timeline, resulting in misleading statements about the company's business and prospects [11].