uniQure plans UK MAA submission for AMT-130 in Q3 2026 after successful MHRA meeting

uniQure N.V.

Successful MHRA pre-submission meeting for AMT-130 gene therapy in Huntington's disease.
Expected MAA submission in Q3 2026 based on Phase I/II three-year data showing 75% slowing of disease progression at high dose.
FDA Type B meeting granted in Q2 2026 to discuss potential Phase III design and four-year analysis plan.
Actively pursuing additional ex-US regulatory pathways for AMT-130; updates expected H2 2026.

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