uniQure files for US and UK approval for AMT-130 in Huntington’s disease

3 September 2026

Dutch gene therapy company uniQure (Nasdaq: QURE) has announced the submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the accelerated approval of ifezuntirgene inilparvovec (AMT-130), an investigational gene therapy for the treatment of Huntington’s disease.

The company also announced that its Marketing Authorization Application (MAA) for ifezuntirgene inilparvovec has been submitted to the UK Medicines and Healthcare products Regulatory Agency (MHRA).

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