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Huntington’s disease
UniQure plans resubmission for Huntington’s gene therapy after FDA reverses course—again
After a regulatory odyssey
that delayed a filing for what would be the first genetic medicine for Huntington’s disease, the FDA has agreed that three-year data from uniQure’s Phase 1/2 trial are sufficient to support an accelerated biologics license application.
June 17, 2026
·
3 min read
·
Heather McKenzie
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