uniQure Submits BLA for AMT-130 in Huntington's Disease

07:41 AM EDT, 09/02/2026 (MT Newswires) -- uniQure (QURE) has submitted a Biologics License Application to the US Food and Drug Administration for the accelerated approval of AMT-130 to treat Huntington's disease, the company said Wednesday. The company has also submitted a Marketing Authorisation Application to the UK Medicines and Healthcare products Regulatory Agency, it said. Both applications are supported by three-year data from a phase 1/2 study showing a slowing of disease progression, uniQure said. The company expects to report four-year data from the ongoing Phase 1/2 studies by the end of Q3. Shares of the company were 4% higher in Wednesday premarket activity.