uniQure Stock Falls 18% as FDA Unlikely to Approve AMT-130 Gene Therapy for Huntington's Disease.

uniQure NV's stock is falling 18% in pre-market trade after the company received final meeting minutes from the FDA regarding a pre-Biologics License Application meeting for its gene therapy, AMT-130, for Huntington's disease. The FDA stated that the submitted Phase I/II study data are unlikely to provide primary evidence for a BLA submission. uniQure plans to request a follow-up meeting with the FDA in Q1 2026.