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uniQure seeks US approval for Huntington's gene therapy after FDA reversal
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Fusion42 · 2 September 2026 · Fusion42 review
uniQure is pursuing US FDA approval for its gene therapy targeting Huntington's disease following a reversal in the FDA's previous stance, signaling regulatory progress in gene therapies for rare neurological conditions.
This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it.
◆ ◆ The Wire takeaway
You must act fast as the FDA's reversal opens a hard-to-access US market for Huntington’s gene therapies. This change rewrites how your clinical and regulatory strategy should align with evolving FDA perspectives.
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2 sources · 2 Sep 2026
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