uniQure (NASDAQ: QURE) on Nov. 3, 2025 announced FDA feedback from a pre-BLA meeting for AMT-130, its investigational gene therapy for Huntington’s disease. uniQure said the FDA now appears to disagree that Phase I/II data versus an external control—as prespecified—may be adequate as primary evidence for a BLA, a material shift from …
Read More »uniQure Provides FDA Update on AMT-130; BLA Timing Unclear
