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)
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