ImmunityBio Receives Authorization from the European Commission for ANKTIVA® with BCG for Non-Muscle Invasive Bladder Cancer Carcinoma in Situ, Expanding Global Access to 33 Countries
ImmunityBio, Inc. (IBRX)
Company Research
Source: Business Wire
ANKTIVA plus BCG, with a 71% complete response rate, is the first immunotherapy to receive marketing authorization in Europe for non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, where no treatment was previously authorized for BCG-unresponsive diseaseEuropean Commission conditional marketing authorization enables commercial availability across all 27 European Union (EU) member states plus Iceland, Norway, and Liechtenstein, bringing the total number of countries where ANKTIVA is authorized to 33ANKTIVA is now authorized across four regulatory jurisdictions: the United States (FDA, April 2024), United Kingdom (MHRA, July 2025), Kingdom of Saudi Arabia (SFDA, January 2026), and the European Union (EC, February 2026)More than 150,000 patients are diagnosed annually with NMIBC across Europe; the European Commission’s decision addresses an unmet medical need where the primary alternative for BCG-unresponsive patients has been radica
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News
- ImmunityBio Partners with Biopharma and Cigalah Healthcare to Launch ANKTIVA® in Saudi Arabia for Bladder and Lung Cancer PatientsBusiness Wire
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of ImmunityBio, Inc. - IBRXPR Newswire
- ImmunityBio Expands Access to ANKTIVA® in EU with New Distribution Partnership and Opens Irish Subsidiary to Support European LaunchBusiness Wire
- ImmunityBio (IBRX) Is Up 29.0% After EU Clears First ANKTIVA+BCG Immunotherapy For NMIBC CIS [Yahoo! Finance]Yahoo! Finance
- ImmunityBio's EU Anktiva Nod Sparks Questions On Valuation And Momentum [Yahoo! Finance]Yahoo! Finance
IBRX
Earnings
- 5/12/25 - Miss
IBRX
Sec Filings
- 2/18/26 - Form 8-K
- 2/12/26 - Form 4
- 2/12/26 - Form 4
- IBRX's page on the SEC website