UniQure files for FDA, UK approval of first gene therapy for Huntington’s disease
BLA FilingAMT-130Positive
AI Analysis
Summary
uniQure filed a biologics license application with the FDA and UK regulators for AMT-130, its gene therapy for Huntington's disease. If accepted for priority review, FDA approval could occur in Q2 2027.
Outcome Details
Biologics license application filed for FDA and UK approval
Importance:8/10
Sentiment:
0.60
gene therapyHuntington's diseaseFDA approvalBLA filingpriority review
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Published by BioSpace on September 2, 2026 1:19 PM