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FDA Grants Priority Review to Huntington Disease Gene Therapy BLA

Published

3 November 2026

Topic

opportunities

◆ Sectors

Biotech

◆ Geography

United States

◆ Source

Read at neurologylive.com →

◆ Verified

Fusion42 · 3 November 2026 · Fusion42 review

FDA accepted uniQure's biologics license application for the Huntington disease gene therapy ifezuntirgene inilparvovec and granted it Priority Review with a target action date of May 1, 2027, under the accelerated approval pathway.

This Wire brief sits within Fusion42's coverage of Biotech, and 3 sources have reported it between 2 Nov 2026 and 3 Nov 2026.

◆ ◆ The Wire takeaway

The FDA's Priority Review signals your Huntington's gene therapy now approaches market access, so start preparing for competitive positioning and confirmatory trials. You must act now to engage payers and build trial readiness before the May 2027 decision.

◆ Coverage

3 sources · first reported 2 Nov 2026 · latest 3 Nov 2026

◆ Related on Wire

◆ Topics

Biotechgene-therapypriority-reviewhuntington-diseaseregulatory-approvalaccelerated-approval