By Mackenzie Tatananni

Gene therapy company uniQure has faced a brutal uphill battle to commercialize its experimental treatment for Huntington's disease, but its outlook suddenly has brightened.

Shares of the Amsterdam-based biopharmaceutical company surged 66% on Wednesday after uniQure said it would seek regulatory approval to bring its gene therapy candidate, AMT-130, to market.

The Food and Drug Administration has cleared uniQure to submit a Biologics License Application for the drug, the company said. A BLA is a formal request to market and distribute a medical product derived from living organisms across state lines.

The FDA's position is an about-face. Months ago, the agency declared that uniQure's Phase I and II data wasn't enough to support a BLA, and as recently as March the agency suggested running another study. In a recent meeting, however, the FDA reversed course, telling uniQure that a three-year analysis of those same Phase I and II trials can now serve as the primary basis for their application.

Write to Mackenzie Tatananni at mackenzie.tatananni@barrons.com

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June 17, 2026 10:10 ET (14:10 GMT)

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