QURE INVESTOR ALERT: uniQure Faces Securities Class Action Over AMT-130 Clinical Trial Design - Hagens Berman

Core Viewpoint - uniQure N.V. is facing a securities class action lawsuit due to alleged misleading statements regarding the clinical trial design of its lead gene therapy candidate, AMT-130, particularly concerning the FDA's acceptance of a pivotal study design that lacked a traditional placebo control [2][4]. Group 1: Lawsuit Details - The lawsuit claims that uniQure and its executives made inaccurate statements about the regulatory path for AMT-130, which is intended to treat Huntington's disease [3][4]. - The class period for the lawsuit is from September 24, 2025, to October 31, 2025, with a lead plaintiff deadline set for April 13, 2026 [3]. - The complaint alleges that the truth about the FDA's stance was revealed on November 3, 2025, when uniQure stated that the FDA no longer agreed that the data from the Phase I/II studies were adequate for a Biologics License Application (BLA) submission [4]. Group 2: Financial Impact - Following the disclosure regarding the FDA's position, uniQure's stock price fell by more than 49% [4]. - The firm Hagens Berman is investigating claims that uniQure violated federal securities laws and is urging investors who suffered significant losses to come forward [3][5]. Group 3: Regulatory Concerns - The investigation focuses on the discrepancies between what uniQure communicated to investors about its interactions with the FDA and the details revealed in the Type A meeting minutes [5]. - Defendants allegedly downplayed the likelihood of needing to delay the BLA timeline to conduct additional studies, despite previously reported successful results from the AMT-130 pivotal study [6].