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On September 2, 2026, uniQure N.V. announced the submission of a Biologics License Application (BLA) to the U.S. Food…
QUREuniQure N.V.
On September 2, 2026, uniQure N.V. announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration for accelerated approval of ifezuntirgene inilparvovec (AMT-130), an investigational gene therapy for Huntington’s disease. The company also submitted a Marketing Authorisation Application (MAA) to the UK Medicines Healthcare products Regulatory Agency. Both applications are supported by three-year data from Phase I/II studies demonstrating slowed disease progression, and uniQure has requested priority review for the BLA. The filing does not contain specific financial figures or dividend announcements.