Mar 30, 2026
The National Comprehensive Cancer Network has updated its bladder cancer guidelines to include ImmunityBio's Anktiva plus BCG for BCG-unresponsive papillary-only disease. The Category 2A recommendation expands treatment options beyond the drug's initial FDA approval for carcinoma in situ. ImmunityBio also announced its pivotal trial is adequately powered and European distribution partnerships to expand global access.
Mar 25, 2026
ImmunityBio reported a fivefold revenue increase to $38.29 million, driven by a 750% surge in unit sales of its cancer drug Anktiva. The company is expanding internationally through partnerships in the Middle East and preparing additional FDA submissions for Anktiva's broader use.
Mar 09, 2026
ImmunityBio resubmitted its supplemental BLA to the FDA for ANKTIVA in papillary bladder cancer after providing additional data. The company also received encouragement from Saudi regulators to submit a recombinant BCG application and expand ANKTIVA approvals.
Feb 27, 2026
ImmunityBio completed enrollment of 366 patients in its Phase 2 trial of ANKTIVA plus BCG versus BCG alone for BCG-naïve bladder cancer. Interim analysis showed statistically significant improvement in duration of complete response, with the company anticipating a BLA submission by Q4 2026.
Feb 20, 2026
The European Commission granted conditional marketing authorization for ImmunityBio's Anktiva for bladder cancer treatment across 27 EU countries. The company partnered with Accord Healthcare to deploy an 85-person sales force across 30 European countries.
Feb 17, 2026
ImmunityBio received European Commission authorization for ANKTIVA in bladder cancer, expanding to 33 countries. The company held productive discussions with Saudi regulators on recombinant BCG and checkpoint inhibitor combinations.
Feb 19, 2026
The European Commission granted conditional marketing authorization for ANKTIVA in combination with BCG for BCG-unresponsive non-muscle invasive bladder cancer, expanding the therapy's availability to 33 countries across four regulatory jurisdictions.
Feb 19, 2026
ImmunityBio has partnered with Accord Healthcare to expand access to Anktiva across 30 countries following conditional EU authorization. The company established an Irish subsidiary to support European distribution and commercialization.
Feb 18, 2026
ImmunityBio's stock jumped 41.9% following the European Commission's conditional marketing authorization for Anktiva combined with BCG to treat BCG-unresponsive non-muscle invasive bladder cancer across 33 European countries.
Feb 14, 2026
The European Medicines Agency recommended conditional marketing authorization for Anktiva in combination with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer in December 2025.
