uniQure N.V. (QURE) Investors: Kessler Topaz Meltzer & Check, LLP Announces That the Firm Has Filed a Securities Fraud Class Action Lawsuit 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 between September 24, 2025, and October 31, 2025, alleging that the company made materially false and misleading statements regarding its drug AMT-130 and its regulatory approval process [1][2]. Group 1: Lawsuit Details - The lawsuit is titled Scocco v. uniQure N.V., filed in the U.S. District Court for the Southern District of New York [1]. - Investors can move to serve as lead plaintiff by April 13, 2026, and the firm encourages those affected to contact them for more information [2]. Group 2: Company Background - uniQure N.V. is a biotechnology company focused on developing gene therapies for rare diseases, particularly Huntington's disease (HD) [1]. - The leading drug candidate, AMT-130, aims to slow the progression of HD, a fatal genetic disorder with no current cure [1]. Group 3: 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) for the basis of a Biologics License Application (BLA) submission [1]. Group 4: Stock Performance and Offering - Following the announcement of positive topline results from the Pivotal Study on September 24, 2025, uniQure's stock price surged nearly 250%, from $13.66 to $47.50 per share [1]. - The company subsequently offered over 5.7 million shares and generated approximately $345 million in proceeds, despite uncertainties regarding AMT-130's future [2]. Group 5: Allegations of Misrepresentation - The complaint alleges that uniQure misrepresented the FDA's approval of the Pivotal Study design and downplayed the likelihood of delays in the BLA timeline [2]. - On November 3, 2025, uniQure disclosed that the FDA no longer agreed that the Pivotal Study data would suffice for a BLA submission, leading to a stock price drop of over 49% [2].