(Updates with recent stock movement in headline and first paragraph.)
UniQure (QURE) shares surged 79% in afternoon trading on Wednesday after the company said that it intends to submit a Biologics License Application for the accelerated approval of AMT-130 to treat Huntington's disease in Q3.
uniQure said the decision was made after a meeting with the US Food and Drug Administration, during which the regulator said that its three-year analysis from a phase 1/2 study would be acceptable as the primary basis of the application.
The FDA also seeks to align with the company on the confirmatory study design before the application is submitted, including consideration of a standard care control group rather than a sham procedure.
"The consistency and strength of the clinical data generated to date give us great confidence in the product's potential to make a meaningful difference for patients," Chief Executive Matt Kapusta said in a statement.
The company expects to receive the final minutes within 30 days of the meeting.
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