By Chris Wack
UniQure shares more than doubled after the company reached agreement with the Food and Drug Administration on key elements of an accelerated approval pathway for AMT-130, a potential treatment for Huntington's disease.
Shares were recently trading at $16.13, hitting a 52-week high.
The gene therapy company said that, as part of its late November meeting, the FDA agreed that data from the ongoing Phase 1/2 studies may serve as the primary basis for a biologics license application submission.
Under the accelerated approval pathway, this would allow UniQure to avoid the need for an additional pre-submission study.
The FDA granted the Lexington, Mass., company a regenerative medicine advanced therapy designation for AMT-130 in May. The designation said that preliminary clinical data from the ongoing Phase 1/2 studies indicate AMT-130 has the potential to address unmet medical needs for the treatment of Huntington's disease.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
December 10, 2024 10:03 ET (15:03 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.
免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。