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FDA to review uniQure's Huntington's gene therapy, decision due on May 2027 | Reuters

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FDA sets May 2027 review date for uniQure's Huntington's gene therapy

The FDA will review uniQure's gene therapy for Huntington's disease, with a decision expected in May 2027. The agency has also scheduled an advisory committee meeting.

Nov 2, 2026·2 sourcesNeurodegenerative diseaseFDA drug approvalClinical trialsGene therapyGenetic diseasesAccelerated approval pathwaysDrug Policy, Pricing & Approval
FDA sets May 2027 review date for uniQure's Huntington's gene therapy
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UniQure gets review date and adcomm; Inovia's stock surges after approval