uniQure Secures FDA Agreement for AMT-130 Approval

uniQure ( (QURE) ) has provided an update.

uniQure has reached an agreement with the FDA on critical elements for the Accelerated Approval pathway for AMT-130, a promising gene therapy for Huntington’s disease. The FDA’s acceptance of data from Phase I/II studies, along with the use of cUHDRS as a clinical endpoint, marks a significant milestone towards delivering this potential treatment. The company plans to engage further with the FDA in 2025, aiming to expedite the availability of AMT-130, which has shown promising results in slowing disease progression.

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