Last mentioned: 3d ago
FDA accepts AMT-130 Phase 1/2 data for BLA
The FDA reversed its earlier requirement for additional data, agreeing existing clinical data supports a near-term BLA submission for Huntington’s gene therapy.
Planned BLA submission in Q3 2026
UniQure intends to submit a Biologics License Application for AMT-130 in the third quarter, pending alignment meeting on confirmatory study design.
FDA’s acceptance of existing clinical data for uniQure’s AMT-130 gene therapy signals a major regulatory win, with the company on track for a BLA submission in Q3 2026 and a potential first-in-class approval for Huntington’s disease.
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