uniQure(US:QURE) Prnewswire·2026-03-11 13:10Core Viewpoint - The article discusses a securities class action against uniQure N.V. (NASDAQ: QURE) due to allegations of misleading statements and failure to disclose critical information regarding the company's Pivotal Study and its implications for the BLA submission timeline [1][2]. Group 1: Allegations Against uniQure - The complaint alleges that uniQure and its executives violated federal securities laws by making false and/or misleading statements [1]. - Specific allegations include that the design of uniQure's Pivotal Study was not fully approved by the FDA and that the company downplayed the likelihood of needing to delay its BLA timeline for additional studies [1]. - The complaint asserts that the statements made by the defendants regarding the company's business, operations, and prospects lacked a reasonable basis [1]. Group 2: Impact of FDA Disclosure - On November 3, 2025, uniQure disclosed that the FDA no longer agreed that data from the Phase I/II AMT-130 studies would be adequate to support a BLA submission [1]. - The company admitted that the timing of any BLA submission for AMT-130 was now unclear, contradicting previous representations of a near-term path toward accelerated approval [1]. - Following this disclosure, uniQure's share price fell by $33.40, or more than 49%, from $67.69 on October 31, 2025, to $34.29 on November 3, 2025 [1]. Group 3: Class Action Participation - The article outlines that the court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class [1]. - Any member of the putative class may move the Court to serve as lead plaintiff or choose to remain an absent class member without affecting their ability to share in any recovery [1]. - The law firm Faruqi & Faruqi, LLP encourages anyone with information regarding uniQure's conduct to contact them, including whistleblowers and former employees [2].