uniQure Plans AMT-130 BLA Submission for Huntington's Disease in Q3 2026

The FDA agreed that uniQure's 3-year Phase I/II data for AMT-130 can serve as the primary basis for accelerated approval of the gene therapy for Huntington's disease, with BLA submission expected in Q3 2026. This regulatory milestone significantly de-risks the pathway to market for the company's lead candidate in a disease with high unmet medical need.