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UniQure gets FDA green light to file for Huntington's gene therapy approval

By Reuters Reuters
FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo ANDREW KELLY Reuters

Dutch drugmaker UniQure said on Wednesday the U.S. Food and Drug Administration has agreed that existing clinical trial data could support an accelerated approval filing for its gene therapy to treat Huntington's disease.

The health regulator told the company during a recent formal meeting that three-year data from an early-to-mid-stage trial would be sufficient as the main basis for submitting a marketing application.

UniQure plans to submit the application in the third quarter of 2026.

Shares of the company were halted in premarket trading.

(Reporting by Kamal Choudhury in Bengaluru; Editing by Jonathan Ananda)

Copyright Reuters or USA Today Network via Reuters Connect

This story was originally published June 17, 2026 at 4:17 AM.

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