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uniQure N.V. Reports FDA Priority Review of BLA for AMT-130 and Third Quarter 2026 Financial Results

Source: Nasdaq

Healthcare & BiotechRegulation & Legislation

The FDA accepted uniQure’s Biologics License Application for ifezuntirgene inilparvovec for review under the Accelerated Approval pathway and granted it Priority Review. This is a positive regulatory milestone, but the article excerpt does not report an approval decision or provide the Prescription Drug User Fee goal date.

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