Enrollment of BCG naïve subjects (QUILT-2.005) receiving BCG alone versus BCG plus ANKTIVA exceeding expectations
85% enrolled with anticipated completion in Q2 2026 with BLA filing to U.S. Food and Drug Administration (FDA) by year end
Interim analysis requested by FDA demonstrated statistically significant longer duration of complete response with ANKTIVA + BCG
Expanded access program (EAP) of recombinant BCG proceeding well
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