uniQure N.V. Submits Regulatory Applications for Huntington's Disease Treatment

AI-generated NewsSnap summary based on source reporting.
Published: 2026-09-02
Category: business
Source: SEC.gov

uniQure N.V. (NASDAQ: QURE) announced the submission of a Biologics License Application to the U.S. Food and Drug Administration (FDA) for accelerated approval of ifezuntirgene inilparvovec (AMT-130) for Huntington's disease. The company also submitted a Marketing Authorisation Application to the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for the same treatment. This was disclosed in an 8-K filing.

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