-- (Updates with the latest stock move in the headline and in the first paragraph.)
UniQure (QURE) shares were up over 18% in Thursday trading after the company said it plans to submit a UK marketing authorization application in Q3 for AMT-130 for the treatment of Huntington's disease.
The plan came after a pre-submission meeting with the UK's Medicines and Healthcare products Regulatory Agency, it 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.
The company said it is pursuing additional regulatory pathways in international markets for the potential registration of AMT-130 and expects to provide further updates in H2.
Price: $19.82, Change: $+3.09, Percent Change: +18.47%