uniQure(US:QURE) Prnewswire·2025-11-20 15:00Core Insights - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving uniQure N.V. and its officers or directors [1] - uniQure announced feedback from the FDA indicating that data from Phase I/II studies of its investigational gene therapy AMT-130 may not be sufficient for a Biologics License Application (BLA) submission, leading to a significant drop in stock price [2] Group 1: Company Developments - On November 3, 2025, uniQure received feedback from the FDA during a pre-BLA meeting regarding AMT-130, a gene therapy for Huntington's disease [2] - The FDA's feedback represents a key shift from previous communications, causing uncertainty about the timing of the BLA submission for AMT-130 [2] - Following the announcement, uniQure's stock price fell by $33.40, or 49.34%, closing at $34.29 per share [2] Group 2: Legal Investigations - Pomerantz LLP is actively investigating claims on behalf of investors of uniQure regarding potential securities fraud [1] - The firm has a long history in corporate and securities class litigation, having recovered significant damages for victims of securities fraud [3]