The plan is clear, ClearPoint Neuro stock surges on peer’s FDA approval plan

ClearPoint Neuro (NASDAQ: CLPT) shares rose 50% Wednesday following UniQure’s announcement that the FDA agreed its 3-year Phase I/II study data could support a Biologics License Application for accelerated approval of AMT-130 in Huntington’s disease.

UniQure’s lead Huntington’s disease therapy, AMT-130, is administered using ClearPoint’s navigation system and SmartFlow cannula.

UniQure (NASDAQ: QURE) said the FDA communicated during a recent Type B meeting that the 3-year analysis from the Phase I/II study would be acceptable as the primary basis of a BLA for accelerated approval. The company intends to submit the BLA in the third quarter of 2026.

The FDA is seeking to align on the confirmatory study design prior to the BLA submission, including consideration of concurrent control on standard-of-care therapy instead of a sham procedure. The FDA communicated it would work as expeditiously as possible with UniQure on this effort.

AMT-130 has been granted Regenerative Medicine Advanced Therapy designation by the FDA, the first RMAT designation for Huntington’s disease, as well as Breakthrough Therapy designation and Fast Track designation.