# 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
Canonical URL: https://biopharmsignal.com/news/IBRX/immunitybio-confirms-statistical-power-in-pivotal-randomized-bcg-naive-nmibc-trial-to-detect-clinically-meaningful-differences-between-anktivar-plus-bcg-versus-bcg-alone-supplemental-bla-submission-on-track-for-2026
Ticker: IBRX
Company: ImmunityBio
Source: ImmunityBio
Published: 2026-03-26 11:30 EST
Original Source URL: https://ir.immunitybio.com
## Summary

The QUILT-2.005 randomized clinical trial is on track for final analysis and supplemental Biologics License Application (BLA) submission in 2026 for the BCG-naïve NMIBC carcinoma in situ with or without papillary indication with no additional enrollment required The Independent Data Monitoring

## Article Body
The QUILT-2.005 randomized clinical trial is on track for final analysis and supplemental Biologics License Application (BLA) submission in 2026 for the BCG-naïve NMIBC carcinoma in situ with or without papillary indication with no additional enrollment required The Independent Data Monitoring
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