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 ...
ImmunityBio, Inc. (IBRX)
Company Research
Source: Business Wire
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 requiredThe Independent Data Monitoring Committee (IDMC) confirmed that the fully enrolled study (N=366) is adequately powered to detect the pre-specified difference in complete response rate between the experimental and control arms, and that no additional enrollment is requiredA planned interim analysis was conducted by the IDMC per the protocol once 50% of enrolled patients (N=183) in Cohort A were evaluable for the primary efficacy endpointThe IDMC reviewed the interim complete response data in 183 evaluable patients comparing ANKTIVA® + BCG to BCG alone to assess whether the current enrollment is sufficient to detect the pre-specified clinically meaningful difference between treatment arms at the protocol-specified power and concl
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News
- ROSEN, THE FIRST FILING FIRM, Encourages ImmunityBio, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action First Filed by the Firm - IBRXGlobeNewswire
- Investor Notice: Robbins LLP Informs Investors of the ImmunityBio, Inc. Class Action LawsuitBusiness Wire
- IBRX INVESTOR ALERT: ImmunityBio, Inc. Investors with Substantial Losses Have Opportunity to Lead the ImmunityBio Class Action Lawsuit – RGRD LawGlobeNewswire
- EQUITY ALERT: Rosen Law Firm Files Securities Class Action Lawsuit on Behalf of ImmunityBio, Inc. Investors – IBRXBusiness Wire
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of ImmunityBio, Inc. - IBRXPR Newswire
IBRX
Earnings
- 5/12/25 - Miss
IBRX
Sec Filings
- 2/26/26 - Form 4
- 2/25/26 - Form SCHEDULE
- 2/24/26 - Form 4
- IBRX's page on the SEC website