QURE SHAREHOLDER NOTICE: Hagens Berman Updates uniQure (QURE) Investigation Following Public FDA Rebukes and Allegations of "Distorted" Data

Core Viewpoint - Hagens Berman is conducting an investigation into uniQure N.V. following significant criticisms from the FDA regarding the company's gene therapy candidate AMT-130, which has been labeled a "failed therapy" and accused of using distorted data in clinical comparisons [1][2]. Group 1: FDA Allegations - An FDA official criticized uniQure for allegedly performing a "distorted or manipulated comparison" in its clinical studies instead of adhering to proper protocols [2]. - The FDA has not approved the use of the ENROLL-HD external historical data set as a primary control for AMT-130, indicating a lack of regulatory consensus on the therapy's evaluation [5]. Group 2: Class Action Lawsuit Details - The securities class action lawsuit, Scocco v. uniQure N.V., alleges that uniQure misrepresented its interactions with the FDA and failed to disclose critical information regarding its clinical study design [3][4]. - Specific allegations include mischaracterization of sham surgeries, denial of prior agreements with the FDA, and misleading statements about the eligibility of AMT-130 for streamlined pathways [4][5]. Group 3: Impact on Investors - The stock price of uniQure fell by 49% following the revelation of the lack of FDA agreement on the Biologics License Application (BLA) timeline, which was previously presented as clear [5]. - Investors who purchased shares during the class period (September 24, 2025 – October 31, 2025) are reminded of the April 13, 2026, deadline to apply as Lead Plaintiff in the ongoing lawsuit [6].