UniQure to Seek FDA Approval to Market Huntington's Disease Drug
By Dean Seal
UniQure said it plans to apply for regulatory approval to market one of its primary investigational gene therapies as a treatment for Huntington's disease.
During a recent meeting with the Food and Drug Administration, the agency told the company that a three-year analysis from a study of UniQure's AMT-130 drug would be acceptable as the primary basis for a Biologics License Application to accelerate approval of the drug in Huntington's disease, UniQure said.
The FDA is also seeking to align on the design of a confirmatiory study prior to the submission of the application, the company said.
UniQure said it is committed to conducting the confirmatory study without delay and expects to align with the FDA on the details. 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 07:56 ET (11:56 GMT)
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