ImmunityBio Receives Conditional Marketing Authorization Recommendation from the European Medicines Agency for ANKTIVA® with BCG for Non-Muscle Invasive Bladder Cancer Carcinoma in Situ—A ...
ImmunityBio, Inc. (IBRX)
Company Research
Source: Yahoo! Finance
tumors, to receive a positive recommendation for marketing authorization in Europe. For patients whose disease does not respond to BCG, there are currently no authorized treatment options; the primary option is surgical removal of the bladder. Unlike the U.S., where only one BCG substrain is approved, Europe recognizes and has approved approximately six major BCG substrains, making standard-of-care therapy broadly available across the region. The recommendation is based on the EMA's determination that the benefit of making ANKTIVA available to patients now outweighs the risks associated with earlier access, providing an important option for adults with BCG-unresponsive NMIBC, and builds on existing approvals in the U.S. and United Kingdom. Each year, more than 150,000 people in Europe are diagnosed with NMIBC. CULVER CITY, Calif., December 12, 2025 BUSINESS WIRE )--ImmunityBio ( NASDAQ: IBRX ), a leading immunotherapy company, announced today that the European Medicines Agency
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News
- Should EMA's Conditional Nod for ANKTIVA in High-Risk Bladder Cancer Require Action From ImmunityBio (IBRX) Investors? [Yahoo! Finance]Yahoo! Finance
- ImmunityBio (IBRX) Climbs 7.76% on Europe Expansion [Yahoo! Finance]Yahoo! Finance
- ImmunityBio (NASDAQ:IBRX) had its "buy" rating reaffirmed by analysts at Jefferies Financial Group Inc..MarketBeat
- ImmunityBio, Novo, Moderna among winners of EU drug recommendations this week [Seeking Alpha]Seeking Alpha
- ImmunityBio Receives Conditional Marketing Authorization Recommendation from the European Medicines Agency for ANKTIVA® with BCG for Non-Muscle Invasive Bladder Cancer Carcinoma in Situ—A First in EuropeBusiness Wire
IBRX
Earnings
- 5/12/25 - Miss
IBRX
Sec Filings
- 12/12/25 - Form 8-K
- 11/10/25 - Form SCHEDULE
- 11/5/25 - Form 8-K
- IBRX's page on the SEC website