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uniQure N.V. Provides Regulatory Update on AMT-130 for Huntington's Disease
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uniQure N.V. announced a regulatory update on its gene therapy AMT-130 for Huntington's disease. The FDA indicated that Phase I/II data is insufficient for BLA submission. uniQure plans to request a follow-up FDA meeting in Q1 2026. The company remains committed to advancing AMT-130 for Huntington's patients, with support from the Huntington's community highlighting the urgency of the treatment.
On December 4, 2025, uniQure N.V. announced a regulatory update on its gene therapy AMT-130 for Huntington's disease.
Key Highlights:
- FDA feedback indicates Phase I/II data insufficient for BLA submission.
- uniQure plans to request a follow-up FDA meeting in Q1 2026.
- Company committed to advancing AMT-130 for Huntington's patients.
- Support from Huntington's community underscores treatment urgency.
Original SEC Filing: uniQure N.V. [ QURE ] - 8-K - Dec. 04, 2025
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