07:56 AM EST, 12/10/2024 (MT Newswires) -- UniQure ( QURE ) shares climbed by more than 70% in premarket trading after saying it has reached agreement with the US Food and Drug Administration on elements of an Accelerated Approval pathway for its drug AMT-130, a potential Huntington's disease treatment.

The company said the FDA accepted data from ongoing phase 1/2 studies as the primary basis for a biologics license application submission under the Accelerated Approval pathway, bypassing an additional pre-submission study.

The FDA also agreed that the composite Unified Huntington Disease Rating Scale can be used as a clinical endpoint for the drug and that reductions in neurofilament light chain measured in cerebrospinal may service as supportive evidence of therapeutic benefit for the purposes of the application process, the company said.

The FDA granted AMT-130 Regenerative Medicine Advanced Therapy Designation in May, the company said.