Why Is UniQure Stock Falling In Pre-market?
uniQure's stock fell 18% in pre-market trading after the FDA indicated that Phase I/II data for AMT-130 might not support a BLA submission. The company plans to request a follow-up meeting with the FDA in early 2026.
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uniQure N.V. (QURE) announced that the company received final meeting minutes from the FDA regarding a pre-Biologics License Application meeting held on October 29, 2025 to discuss the application for AMT-130, an investigational gene therapy for Huntingtons disease. In the final meeting minutes, the FDA conveyed that data submitted from the Phase I/II studies of AMT-130 are currently unlikely to provide the primary evidence to
support a BLA submission.
uniQure said it is evaluating the feedback and plans to urgently request a follow-up meeting with the FDA to take place in the first quarter of 2026.
Shares of uniQure are down 18% in pre-market trade on Thursday.
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