India, April 30 -- uniQure N.V. (QURE) said it has completed a successful pre-submission meeting with the UK Medicines and Healthcare products Regulatory Agency (MHRA), clearing the path for a planned Marketing Authorization Application (MAA) for AMT-130 in Huntington's disease in the third quarter of 2026.
The company described the interaction as "constructive," noting that regulators reviewed the data package and manufacturing requirements needed to support the submission.
Huntington's disease is a rare, inherited neurodegenerative disorder that progressively impairs movement, cognition, and behavior. AMT-130, uniQure's investigational gene therapy, is being evaluated in ongoing U.S. and European Phase I/II trials. According to the comp...