uniQure announces Type A meeting scheduled with FDA

uniQure (QURE) announced a Type A meeting with the U.S. Food and Drug Administration has been scheduled to discuss the Biologics License Application data package to support accelerated approval of AMT-130, the Company’s investigational gene therapy for the treatment of Huntington’s disease. “We look forward to a constructive discussion with the FDA as we work toward a timely resolution regarding an accelerated approval pathway for AMT-130,” said Matt Kapusta, CEO. “The Huntington’s disease community, including patients and clinicians, has emphasized the profound unmet medical need and the importance of timely access to potentially disease-modifying therapies such as AMT-130. We remain deeply committed to patient access while continuing to collaborate closely with the FDA.”