ImmunityBio Advances First-Line BCG Naive NMIBC Program with Enrollment Exceeding Expectations and Positive Interim Analysis for ANKTIVA® Plus BCG
ImmunityBio, Inc. (IBRX)
Company Research
Source: Business Wire
Enrollment of BCG naïve subjects (QUILT-2.005) receiving BCG alone versus BCG plus ANKTIVA exceeding expectations85% enrolled with anticipated completion in Q2 2026 with BLA filing to U.S. Food and Drug Administration (FDA) by year endInterim analysis requested by FDA demonstrated statistically significant longer duration of complete response with ANKTIVA + BCGExpanded access program (EAP) of recombinant BCG proceeding well CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX) today announced an update on the status of enrollment in its randomized registrational trial in BCG-naïve non-muscle-invasive bladder cancer (NMIBC), QUILT-2.005. Enrollment has exceeded internal expectations and is now over 85% complete, with full enrollment of the planned study population anticipated by Q2 2026. Based on the current enrollment trajectory, ImmunityBio anticipates submitting a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) by year end 2026
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IBRX
Earnings
- 5/12/25 - Miss
IBRX
Sec Filings
- 1/16/26 - Form 144
- 1/15/26 - Form 8-K
- 1/14/26 - Form 8-K
- IBRX's page on the SEC website