uniQure plans UK regulatory filing for Huntington's disease gene therapy
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uniQure Announces Successful UK MHRA Pre-Submission Meeting for AMT-130 in Huntington’s Disease
April 30, 2026 7:05 AM EDT~ Submission of a UK Marketing Authorization Application for AMT-130 is expectedÂ
in the third quarter of 2026 ~
~ Type B Meeting with U.S. FDA granted in second quarter; expect to discuss potential Phase III design and analysis plan for AMT-130 four-year data ~
~ uniQure actively pursuing additional ex-US regulatory pathways to support potential registration of
AMT-130 in international markets ~
LEXINGTON, Mass. and AMSTERDAM, April 30, 2026 (GLOBE NEWSWIRE) --... More
