UniQure Shares Soar on Go-to-Market Plan
By Dean Seal
Shares of UniQure surged in premarket trading after the company said it would seek regulatory approval to bring its investigational gene therapy to market as a treatment for Huntington's disease.
The stock was up 75% at $47.30 ahead of Wednesday's opening bell. Shares have had a volatile year, having fallen to nearly $9 back in March.
The gene therapy company said the U.S. Food and Drug Administration gave it a nod to submit a Biologics License Application to accelerate approval of its AMT-130 drug to treat Huntington's disease.
The FDA told UniQure in a recent meeting that a three-year analysis from a study of AMT-130 would be acceptable as the primary basis for the application, according to the company.
The agency is also seeking to align on the design of a confirmatory study prior to the submission of the application, the company said. It aims to submit the application in the third quarter of this year.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
June 17, 2026 09:28 ET (13:28 GMT)
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