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May 17, 2026
ImmunityBio said the Saudi FDA encouraged submission of a regulatory package for recombinant BCG and opened talks on expanding ANKTIVA with checkpoint inhibitors to additional tumor types. The company expects to file the rBCG package within weeks.
May 14, 2026
CEL-SCI said it expects to begin summer 2026 enrollment in a 212-patient U.S. confirmatory registration study of Multikine in head and neck cancer. The company also said it submitted a Breakthrough Medicine Designation application in Saudi Arabia and reported quarterly net loss of $5.5 million.
Apr 25, 2026
ImmunityBio has commercially launched ANKTIVA in Saudi Arabia for approved bladder and metastatic non-small cell lung cancer indications. The launch follows accelerated approval in lung cancer and extends the drug’s commercial rollout in MENA.
Mar 26, 2026
Quoin Pharmaceuticals has secured Orphan Drug Designations for QRX003 in the U.S. and Europe for Netherton Syndrome, while advancing regulatory pathways in Japan and Saudi Arabia. The company reported clinical progress including expansion of pediatric studies and potential for a Priority Review Voucher worth up to $200 million.
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 21, 2026
ImmunityBio receives conditional EU marketing authorization for Anktiva combination therapy in bladder cancer, covering 33 countries, while establishing distribution partnerships in Saudi Arabia for bladder and lung cancer patients.
Feb 24, 2026
ImmunityBio announced $113 million in net product revenue for Anktiva in 2025, a 700% year-over-year increase, while expanding regulatory authorization to 33 countries and securing first approval for lung cancer treatment in Saudi Arabia.
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 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 Commission granted conditional marketing authorization for ANKTIVA plus BCG to treat BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, marking the first approved immunotherapy for this indication in Europe.
