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UniQure, after setbacks, seeks FDA approval of Huntington’s gene therapy

BioPharma DiveView source article

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UniQure seeks FDA approval for Huntington's gene therapy after reversal

Dutch biotech UniQure submitted its Huntington's disease gene therapy to the FDA for approval after the agency reversed its earlier position on the experimental treatment, following an unusually turbulent development process.

Sep 2, 2026·3 sourcesGene therapyFintech regulation
UniQure seeks FDA approval for Huntington's gene therapy after reversal
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Other sources for this story

STAT News

Pharmalittle: We're reading about a Huntington's gene therapy, Novo's challenges, and more

Reuters

uniQure seeks US approval for Huntington's gene therapy after FDA reversal | Reuters

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