ImmunityBio Completes Enrollment in Pivotal Randomized Trial Evaluating ANKTIVA® Plus BCG Versus BCG Alone in BCG-Naïve Non-Muscle Invasive Bladder Cancer Carcinoma In Situ
ImmunityBio, Inc. (IBRX)
Company Research
Source: Business Wire
Study fully enrolled ahead of schedule, with 366 of 366 BCG-naïve NMIBC patients randomized to receive BCG alone or ANKTIVA plus BCGInterim analysis requested by the FDA demonstrated a statistically significant improvement in duration of complete response with ANKTIVA plus BCG, with no significant safety signals observedCompany anticipates submitting a biologics license application (BLA) to the U.S. FDA by Q4 2026Expanded access program (EAP) of recombinant BCG is ongoing, with 580 patients currently enrolled throughout the U.S. CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced completion of enrollment in its Phase 2 clinical trial evaluating ANKTIVA® (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) versus BCG alone in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors.The QUILT 2.005 trial (NCT02138734), which co
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- ImmunityBio to Provide a Business Update and Review Financial Results for FY 2025 on Tuesday, March 3, 2026 [Yahoo! Finance]Yahoo! Finance
- ImmunityBio to Provide a Business Update and Review Financial Results for FY 2025 on Tuesday, March 3, 2026Business Wire
- Assessing ImmunityBio (IBRX) Valuation After Trial Progress And Strong Anktiva Commercial Momentum [Yahoo! Finance]Yahoo! Finance
- Is It Too Late To Consider ImmunityBio (IBRX) After The Recent Share Price Surge? [Yahoo! Finance]Yahoo! Finance
- SHINE Raises $240 Million in Funding to Advance Commercial Fusion Technology [Yahoo! Finance]Yahoo! Finance
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