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UniQure Stock Plummets 67% After FDA Reversal

11/3/2025

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Summary

Story summary

UniQure's stock fell 67% in premarket trading on November 3, 2025, after the U.S. Food and Drug Administration (FDA) reversed its stance on AMT-130 for Huntington's disease.
The FDA no longer considers Phase I/II data sufficient for a Biologics License Application.
CEO Matt Kapusta expressed disappointment about the impact on patients.
UniQure plans to engage with the FDA to pursue alternative pathways while retaining Breakthrough Therapy and RMAT designations.

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Story summary

UniQure's stock fell 67% in premarket trading on November 3, 2025, after the U.S. Food and Drug Administration (FDA) reversed its stance on AMT-130 for Huntington's disease.
The FDA no longer considers Phase I/II data sufficient for a Biologics License Application.
CEO Matt Kapusta expressed disappointment about the impact on patients.
UniQure plans to engage with the FDA to pursue alternative pathways while retaining Breakthrough Therapy and RMAT designations.