ImmunityBio Confirms Statistical Power in Pivotal Randomized BCG-Naïve NMIBC Trial to Detect Clinically Meaningful Differences Between ANKTIVA® Plus BCG Versus BCG Alone; Supplemental BLA Submission on Track for 2026

AI Briefing

• – Immunotherapy company ImmunityBio announces positive interim data from trial of ANKTIVA + BCG versus BCG alone for non-muscle invasive bladder cancer.
• – The study is on track for a supplemental Biologics License Application (BLA) submission in 2026.
• – The Interim Data Monitoring Committee recommends the study is adequately powered to detect clinically meaningful differences in complete response rate.