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uniQure Announces FDA Acceptance and Priority Review of BLA for Huntington's Disease Gene Therapy

Fiscal.ai

The U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ifezuntirgene inilparvovec, uniQure's investigational gene therapy for Huntington's disease.

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  1. SEC EDGARSEC EDGAR

    8-K filing — uniQure N.V. (QURE)

    Filed: 2026-11-04 AccNo: 0001104659-26-122362 Size: 305 KB Item 2.02: Results of Operations and Financial Condition Item 9.01: Financial Statements and Exhibits