UniQure to submit UK marketing application for Huntington's gene therapy AMT-130

UniQure announced it will file a marketing application in the United Kingdom later this year for its gene therapy AMT-130 aimed at Huntington's disease.

The filing follows a positive meeting with UK regulators and relies on three years of data from ongoing trials in the United States and Europe that showed a slowing of disease progression at the highest dose tested.

The company called the submission an important milestone for the Huntington's community and reaffirmed its commitment to work with regulators worldwide.

UniQure also said it has a scheduled meeting with the U.S. Food and Drug Administration in the second quarter, after the agency asked for a new trial before considering approval.