FDA says uniQure's AMT-130 Phase I/II data unlikely to support BLA submission

uniQure N.V.

FDA final meeting minutes from Oct 29 pre-BLA meeting: Phase I/II data for AMT-130 unlikely to support BLA submission.
uniQure plans to request follow-up FDA meeting in Q1 2026 to discuss path forward.
AMT-130 targets Huntington's disease; company evaluating FDA feedback.
CEO Matt Kapusta reaffirms commitment to advancing AMT-130.

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