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uniQure Receives FDA Meeting Minutes, Plans Urgent Follow-Up Meeting in 2026
ByAinvest
Thursday, Dec 4, 2025 7:22 am ET1min read
uniQure has received final meeting minutes from the FDA regarding its investigational gene therapy for Huntington's disease, AMT-130. The FDA stated that the data from the Phase I/II studies are unlikely to support a BLA submission. uniQure plans to request a follow-up meeting with the FDA in Q1 2026 to discuss further. The company remains committed to advancing AMT-130 for patients with severe medical needs.
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