QURE ALERT: Hagens Berman Updates uniQure (QURE) Investigation Following Public FDA Rebukes and Allegations of “Distorted” Data

Core Viewpoint - The investigation into uniQure N.V. is prompted by significant criticisms from FDA officials regarding the company's gene therapy candidate AMT-130, leading to a securities class action lawsuit for investors who acquired shares during a specified period [1][3][5]. Group 1: FDA Criticism - An FDA official labeled AMT-130 as a "failed therapy" and accused uniQure of conducting a "distorted or manipulated comparison" in its clinical studies [3]. - 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 [8]. - The FDA official clarified that the agency's requirements for sham surgeries were mischaracterized by uniQure, stating that the FDA did not request invasive procedures [7]. Group 2: Class Action Allegations - The securities class action alleges that uniQure misrepresented its interactions with the FDA and failed to disclose critical information regarding its pivotal study design [5][6]. - Allegations include misleading investors about the necessity of a sham-controlled surgery arm for Phase III trials, which the FDA claims was never waived [8]. - The lawsuit also points to a timeline deception regarding the Biologics License Application (BLA), which became unclear after the FDA's lack of agreement was revealed, resulting in a 49% drop in stock value [8]. Group 3: Investor Information - Investors who purchased uniQure shares between September 24, 2025, and October 31, 2025, are encouraged to participate in the class action, with a deadline for Lead Plaintiff applications set for April 13, 2026 [1][6].