What's Going On With uniQure Stock On Tuesday?
uniQureuniQure(US:QURE) Benzinga·2025-12-16 17:17

Core Viewpoint - uniQure NV's stock has experienced a significant decline of approximately 31% over the past month, attributed to concerns regarding its investigational gene therapy for Huntington's disease and feedback from the FDA [1][2]. Group 1: Stock Performance - uniQure stock reached a peak of $22 before experiencing a downturn during trading hours, with no specific news to justify this fluctuation [2]. - As of the latest publication, uniQure's stock was trading at $20.40, reflecting a decrease of 0.14% [5]. Group 2: FDA Feedback and Study Data - The FDA has expressed disagreement with the data from the Phase 1/2 studies of AMT-130, indicating that the data may not be sufficient to support a Biologics License Application (BLA) submission [3][4]. - In September, uniQure released topline data from the pivotal Phase 1/2 study of AMT-130, which met its prespecified primary endpoint, showing a statistically significant slowing of disease progression at 36 months compared to an external control [4][5].