UniQure (QURE) said Monday it has reached alignment with the US Food and Drug Administration on several key elements needed for a biologics license application, or BLA, for AMT-130, its investigational gene therapy for Huntington's disease.
The company said it achieved alignment on the statistical analysis plan and Chemistry, Manufacturing, and Controls information to support the BLA submission planned for Q1 2026.
UniQure plans to request for priority review designation along with its BLA submission, it added. AMT-130 has been granted FDA's regenerative medicine advanced therapy and breakthrough therapy designations.
Shares of UniQure were up about 3.8% in recent trading Monday.
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