UniQure said the FDA agreed that data from its mid-stage study could support an accelerated approval filing for its Huntington's disease gene therapy. The regulatory alignment reduces a key approval hurdle and improves the drug's development outlook. The news is supportive for UniQure shares, though the impact is still contingent on further clinical and regulatory progress.
UniQure said the FDA agreed that data from its mid-stage study could support an accelerated approval filing for its Huntington's disease gene therapy. The regulatory alignment reduces a key approval hurdle and improves the drug's development outlook. The news is supportive for UniQure shares, though the impact is still contingent on further clinical and regulatory progress.
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