QURE ALERT: FDA Reportedly Accuses uniQure of Pushing “Distorted” and “Manipulated” Data For “Failed” AMT-130 Drug Amid Pending Securities Class Action – Hagens Berman

Core Viewpoint - Federal health officials have publicly condemned uniQure N.V. for allegedly providing misleading information regarding its gene therapy candidate AMT-130, which is intended to treat Huntington's disease, leading to a significant decline in the company's stock price and the initiation of a securities class action lawsuit [3][4][5]. Company Overview - uniQure N.V. is under investigation by Hagens Berman following a class action lawsuit that targets investors who acquired shares between September 24, 2025, and October 31, 2025 [1][6]. - The company's lead gene therapy candidate, AMT-130, has faced scrutiny from the FDA, which stated that the data from its testing was flawed and did not meet the approval criteria [4][5]. Allegations and Legal Proceedings - The class action lawsuit alleges that uniQure misrepresented the adequacy of data from its Phase I/II studies and failed to disclose that the FDA did not approve the design of its pivotal study [6][7]. - The lawsuit claims that uniQure downplayed the likelihood of needing to delay its Biologics License Application (BLA) timeline due to the need for additional studies [7]. - Following the negative reports, uniQure's stock price plummeted nearly 84% from November 3, 2025, to the time of the Wall Street Journal publication [5]. Financial Impact - The announcement regarding the unclear timing of the BLA submission for AMT-130 resulted in a more than 49% drop in uniQure's share price [8]. - The investigation by Hagens Berman focuses on discrepancies between what uniQure communicated to investors and the details revealed in recent FDA meeting minutes [9].