Investor Alert: A Securities Fraud Class Action Lawsuit Has Been Filed Against uniQure N.V. (QURE) - Contact Kessler Topaz Meltzer & Check, LLP

Core Viewpoint - A securities fraud class action lawsuit has been filed against uniQure N.V. for allegedly misleading investors regarding the efficacy and regulatory approval timeline of its gene therapy AMT-130 for Huntington's disease [1][2] Company Overview - uniQure N.V. is a biotechnology company focused on developing gene therapies for rare diseases, particularly Huntington's disease [1] - The leading drug candidate, AMT-130, aims to slow the progression of Huntington's disease, a fatal genetic disorder with no current cure [1] Clinical Trials and FDA Interaction - uniQure completed patient enrollment for two ongoing Phase I/II clinical trials for AMT-130 in March 2022 [1] - The FDA had previously agreed that the Pivotal Study results could be compared to an external historical dataset (Enroll-HD) instead of using a placebo comparator [1] - The company claimed that the results indicated a significant reduction in neurodegeneration, leading to expectations of accelerated approval from the FDA [1] Stock Performance and Fundraising - Following the announcement of positive topline results on September 24, 2025, uniQure's stock price surged nearly 250%, from $13.66 to $47.50 per share [1] - The company subsequently raised approximately $345 million through a public offering of over 5.7 million shares, despite uncertainties regarding AMT-130's approval timeline [2] Disclosure of Material Information - On November 3, 2025, uniQure disclosed that the FDA no longer agreed that the data from the Phase I/II studies would support a BLA submission, leading to a stock price drop of over 49% [2] - The lawsuit alleges that uniQure misrepresented the approval status of the Pivotal Study and downplayed the likelihood of delays in the BLA submission process [2]