FDA Authorizes ImmunityBio to Provide Recombinant BCG (rBCG) to Urologists to Address TICE® BCG Shortage
ImmunityBio, Inc. (IBRX)
Company Research
Source: Business Wire
Next-generation recombinant Bacillus Calmette-Guérin (rBCG) has undergone Phase 2 clinical trials in Europe in non-muscle invasive bladder cancer (NMIBC)Supplies of rBCG are now available, with shipments set to begin immediately via an FDA Expanded Access ProgramMultiple U.S. patents issued and allowed on combination of BCG plus ANKTIVA®Thousands of vials of rBCG available to end shortage of TICE® BCG CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the U.S. Food and Drug Administration (FDA) has authorized an expanded access program (EAP) that will bring a vital alternative source of BCG, a standard-of-care medicine in bladder cancer, to patients in the U.S.Supply shortages of TICE® BCG in the U.S. have become a significant impediment to the treatment of bladder cancer patients. In a recent Sermo survey of 100 U.S. urologists, 57 percent indicated they were unable to treat patients in the last 12 months due to
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News
- Jefferies Lifts ImmunityBio Inc. (IBRX) Price Target Following Anktiva European Expansion [Yahoo! Finance]Yahoo! Finance
- ImmunityBio: Anktiva Revenue Will Ramp, But Competitive Risks Remain [Seeking Alpha]Seeking Alpha
- ImmunityBio (NASDAQ:IBRX) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- ANKTIVA® with BCG Demonstrates 96% Survival from Bladder Cancer at Three Years with Median Survival Not Yet Reached in BCG-Unresponsive High-Grade Papillary-Only Non-Muscle Invasive Bladder CancerBusiness Wire
- Should EMA's Conditional Nod for ANKTIVA in High-Risk Bladder Cancer Require Action From ImmunityBio (IBRX) Investors? [Yahoo! Finance]Yahoo! Finance
IBRX
Earnings
- 5/12/25 - Miss
IBRX
Sec Filings
- 12/16/25 - Form 4
- 12/16/25 - Form 3
- 12/15/25 - Form 8-K
- IBRX's page on the SEC website