uniQure Provides Regulatory Update on AMT-130 for Huntington's Disease (GlobeNewswire) - Dec 4, 2025 - "In the final meeting minutes, and consistent with uniQure's November 3, 2025 press release, the FDA conveyed that data submitted from the Phase I/II studies of AMT-130 are currently unlikely to provide the primary evidence to support a BLA submission. uniQure is carefully evaluating the feedback and plans to urgently request a follow-up meeting with the FDA to take place in the first quarter of 2026."
FDA event • CNS Disorders • Huntington's Disease
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