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Monday, June 3, 2024

uniQure FDA Regenerative Medicine Advanced Therapy Designation in Huntington’s Disease

~ Designation based on 24-month interim Phase I/II clinical data for AMT-130 announced in December 2023 ~

~ AMT-130 is the first therapeutic candidate to receive RMAT Designation for Huntington’s disease ~

~ Receiving RMAT designation enables increased collaboration with the FDA on regulatory approval planning, in addition to the opportunity for expedited product development ~

https://www.globenewswire.com/news-release/2024/06/03/2892124/0/en/uniQure-Receives-FDA-Regenerative-Medicine-Advanced-Therapy-RMAT-Designation-for-Investigational-Gene-Therapy-AMT-130-in-Huntington-s-Disease.html

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