uniQure received final meeting minutes from the FDA regarding a pre-BLA meeting for AMT-130
FDA conveyed that data from Phase I/II studies of AMT-130 may not support BLA submission
uniQure plans to request a follow-up meeting with the FDA in Q1 2026
FDA Feedback
Data from Phase I/II studies may not support BLA submission
Community Support
Strong support from Huntington's disease community for urgent treatment advancement
Company Commitment
uniQure committed to collaborating with FDA for patient access to AMT-130
- The FDA's feedback indicates potential challenges in the BLA submission process for AMT-130
- Strong community support highlights the urgent need for effective treatments in Huntington's disease
Despite challenges, uniQure remains dedicated to advancing AMT-130 in collaboration with the FDA and the Huntington's disease community.