UniQure to file gene therapy for approval, reflecting major shifts at FDA
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UniQure is moving to file its gene therapy, AMT-130, for approval, potentially marking a significant development in the treatment of Huntington's disease. The decision appears to follow a shift in stance by the FDA, although the nature and implications of this change are not entirely clear. The company is also planning a regulatory filing in the UK, and its gene therapy has reportedly met endpoints in a study, with some outlets suggesting it may be on an accelerated path for approval.
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