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

Core Viewpoint - Hagens Berman is updating its 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" by FDA officials [2][3]. Group 1: FDA Allegations - The FDA has accused uniQure of conducting a "distorted or manipulated comparison" in its clinical studies, suggesting that the company did not run a proper clinical study [2][4]. - Allegations include that uniQure misrepresented its interactions with the FDA and used a pivotal study design that was not approved by the agency [3][4]. Group 2: Class Action Details - A securities class action lawsuit has been filed against uniQure, alleging that the company failed to disclose critical information regarding the eligibility of AMT-130 for the "Plausible Mechanism" pathway and mischaracterized the requirements for sham surgeries [4][5]. - The lawsuit claims that uniQure misled investors about the timing of a Biologics License Application (BLA), which became unclear after the FDA's lack of agreement was revealed, resulting in a 49% drop in stock price [5][6]. Group 3: Critical Deadlines - Investors who purchased uniQure shares during the class period from September 24, 2025, to October 31, 2025, have until April 13, 2026, to apply as Lead Plaintiff in the ongoing securities class action [6].