uniQure(US:QURE) Prnewswire·2026-03-10 12:37Core Viewpoint - The FDA has publicly criticized uniQure N.V. for allegedly presenting "distorted" and "manipulated" data regarding its gene therapy candidate AMT-130, which is intended to treat Huntington's disease, amid a pending securities class action lawsuit [1][2]. Summary by Relevant Sections FDA Criticism - Federal health officials, including a senior FDA official, stated that the data from uniQure's testing were flawed and did not meet the approval standards [1][2]. - The Wall Street Journal reported that an HHS official accused uniQure of lying and issuing misleading statements regarding the therapy [1][2]. Stock Price Impact - Following the negative reports, uniQure's stock price has plummeted nearly 84% since November 3, 2025, when the company first disclosed issues with its data [1][2]. Securities Class Action Details - A securities class action lawsuit has been filed for investors who acquired uniQure shares between September 24, 2025, and October 31, 2025 [1]. - The lawsuit alleges that uniQure misrepresented the likelihood of success for AMT-130 and failed to disclose necessary delays in its Biologics License Application (BLA) timeline [1][2]. Allegations of Misrepresentation - The complaint highlights that the design of the pivotal study was not fully approved by the FDA, and the company downplayed the need for additional studies to support its BLA submission [1][2]. - The truth about the inadequacy of the data was revealed on November 3, 2025, leading to a significant drop in the stock price by over 49% [1][2].