uniQure Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington's Disease
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uniQure has reached an agreement with the FDA on the key elements of the accelerated approval pathway for its AMT-130 treatment for Huntington's Disease. The FDA has agreed that data from ongoing Phase I/II studies, compared to a natural history external control, can serve as the primary basis for a Biologics License Application (BLA) for Accelerated Approval.
December 10, 2024 | 12:30 pm
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uniQure has secured FDA agreement on the accelerated approval pathway for AMT-130, a treatment for Huntington's Disease. This agreement allows the use of Phase I/II study data as the primary basis for a Biologics License Application.
The FDA's agreement on the accelerated approval pathway is a significant regulatory milestone for uniQure, potentially expediting the market entry of AMT-130. This development is likely to positively impact uniQure's stock price in the short term as it reduces regulatory uncertainty and brings the company closer to commercializing its treatment for Huntington's Disease.
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