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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April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.