UniQure Soars After FDA Reversal on Huntington’s Therapy (3)

UniQure NV shares soared after the company announced it will be able to seek US approval for its Huntington’s disease gene therapy before conducting a new study, a dramatic reversal that shows the Trump administration is relaxing its previous hard-line stance on drug reviews.

The US Food and Drug Administration told the company during a recent meeting that data from its existing study would be acceptable for an expedited approval filing, UniQure said in a statement. It plans to submit an application in the third quarter of this year.

The two sides will agree on the design of a ...