UniQure Shares Sink After Negative FDA Response to Huntington's Disease Treatment
By Nicholas G. Miller
Shares of UniQure sank in premarket trading after the company said it received negative feedback from the Food and Drug Administration about studies of its investigational gene therapy to treat Huntington's Disease.
The stock fell 59% to $27.96 in premarket trading after closing Friday having more than tripled in value this year.
The gene-therapy company on Monday said the FDA no longer agrees that data from the studies of the therapy, called AMT-130, are adequate to support a biologics license application. "Consequently, the timing of the BLA submission for AMT-130 is now unclear," the Amsterdam-based company said.
The FDA previously granted AMT-130 breakthrough-therapy designation based on data from the studies.
UniQure said it "plans to urgently interact with the FDA to find a path forward for the timely accelerated approval of AMT-130."
Write to Nicholas G. Miller at nicholas.miller@wsj.com.
(END) Dow Jones Newswires
November 03, 2025 08:34 ET (13:34 GMT)
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