NasdaqGS:QUREBiotechs
uniQure (QURE) Is Down 14.1% After FDA Alters AMT-130 Approval Pathway - Has The Bull Case Changed?
In early November 2025, uniQure announced that the U.S. Food and Drug Administration no longer supports using Phase I/II data with external controls as the primary evidence for a Biologics License Application for AMT-130, its investigational gene therapy for Huntington's disease.
This sudden regulatory shift created uncertainty regarding the product’s approval pathway, despite recent promising clinical data and prior breakthrough designations for AMT-130.
We'll explore how increased...