Core Viewpoint - The article discusses a securities fraud class action lawsuit against uniQure N.V. due to a delay in FDA approval for its drug candidate AMT-130, which led to a significant stock price decline of 49% [1] Summary by Relevant Sections Lawsuit Details - The lawsuit alleges that uniQure and its executives failed to disclose material information during the class period from September 24, 2025, to October 31, 2025, violating federal securities laws [1] - The company had previously indicated a high likelihood of receiving accelerated FDA approval for AMT-130 after a planned Biologics License Application (BLA) submission in Q1 2026 [1] - On November 3, 2025, uniQure announced that the FDA no longer agreed that the data from Phase I/II studies were adequate for BLA submission, resulting in an unclear timeline for the submission [1] Stock Price Impact - Following the FDA announcement, uniQure's stock price fell from $67.69 per share on October 31, 2025, to $34.29 per share on November 3, 2025, a decline of $33.40 per share or over 49% [1] Legal Actions - Investors who suffered substantial losses have until April 13, 2026, to file lead plaintiff applications in the class action lawsuit [1] - The case is identified as Scocco v. uniQure N.V., et al., Case No. 1:26-cv-01124 [1]
uniQure N.V. Securities Fraud Class Action Result of FDA Approval Delay and 49% Stock Decline - Investors May Contact Lewis Kahn, Esq, at Kahn Swick & Foti, LLC