ClearPoint Neuro Shares Soar 50% on FDA Acceptance of Three-Year AMT-130 Data
CLPT•ClearPoint Neuro shares jumped 50% after partner UniQure secured FDA agreement that three-year Phase I/II data may form the primary basis of its accelerated Biologics License Application for Huntington’s disease candidate AMT-130. UniQure plans to file the BLA in Q3 2026, highlighting ClearPoint’s platform role.
1. Surge Driven by UniQure Regulatory Milestone
ClearPoint Neuro shares surged 50% after UniQure received positive feedback during a Type B meeting in which the FDA agreed that three-year Phase I/II data may serve as the primary basis for an accelerated BLA for AMT-130.
2. FDA Accepts Three-Year Phase I/II Data
The FDA indicated that long-term safety and efficacy data from the Phase I/II study could satisfy accelerated approval requirements, enabling UniQure to target a BLA submission in the third quarter of 2026.
3. Platform Validation and Next Steps
ClearPoint’s navigation platform with the SmartFlow cannula is critical for AMT-130 delivery, and this regulatory progress could bolster adoption of its neurosurgical technologies; UniQure expects meeting minutes within 30 days and will finalize confirmatory study design ahead of filing.
