First Gene Therapy for Huntington's Disease Seeks FDA Approval

UniQure has officially submitted its experimental gene therapy AMT-130 to the FDA for accelerated approval, marking the first potential treatment targeting the underlying cause of Huntington's disease. The Dutch biotech is requesting priority review, which could yield an FDA decision in about eight months. The submission follows a tumultuous year in which the FDA initially told UniQure it could not seek approval based on its Phase 1/2 trial data—only to reverse that...