uniQure holds Type B meeting with FDA; BLA submission pathway for AMT-130 confirmed

uniQure/AMT-130

uniQure announced a successful Type B meeting with the US FDA in June 2026. The FDA agreed that a Biologics License Application submission for AMT-130 under the accelerated approval pathway, based on the existing 36-month Phase 1/2 clinical data, is a reasonable path forward. This cleared the way for a BLA submission in Q3 2026.

• FDA confirmed BLA pathway for AMT-130 under accelerated approval.
• 36-month Phase 1/2 data deemed sufficient for BLA support.
• Accelerated approval recognizes unmet medical need in Huntington's disease.
• Four-year Phase 1/2 data expected September 2026 to support BLA.
• UK MHRA pre-submission meeting also held successfully in spring 2026.