10 min read | The FDA wants more data before approving AMT-130 for Huntington’s disease in the U.S. On March 2026, uniQure ...

分析师将密切关注uniQure与FDA安排的A类会议的任何最新进展,该会议旨在讨论AMT-130的生物制品许可申请数据包。A类会议是为陷入停滞的项目保留的紧急高优先级讨论,通常在30天内举行,官方会议纪要通常会在不久后发布。

Announced alignment with the U.S. FDA on key elements of the Accelerated Approval pathway for AMT-130 in Huntington’s disease, moving closer to the potential approval of a disease-modifying treatment.

uniQure recently divested from its Lexington facility to Genezen and freed $25 million while significantly reducing its operating costs. At the same time, AMT-130 has received the FDA’s Breakthrough ...

Uniqure NV shares (NASDAQ:QURE) closed July 9 at $6.67, up $2.89, or 76%, after the firm made public updated interim data including up to 24 months of follow-up findings from 29 treated patients ...