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UniQure Plans to Submit UK Marketing Authorization Application for Huntington's Disease Treatment

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-- UniQure (QURE) said Thursday it plans to submit a UK marketing authorization application in Q3 for AMT-130 for the treatment of Huntington's disease.

The decision to submit was made after a pre-submission meeting with the UK's Medicines and Healthcare products Regulatory Agency, the company said.

The company said it has also been granted a Type B meeting with the US Food and Drug Administration in Q2, and expects to discuss key elements of a potential phase III trial design and to receive feedback on analysis plan in Q3.

The company is actively pursuing additional regulatory pathways in international markets for the potential registration of AMT-130 and expects to provide further updates in H2, it said.

Price: $19.02, Change: $+2.29, Percent Change: +13.66%

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