Market reaction
Shares of ImmunityBio (NYSE:IBRX) increased by 5.6% after management held productive regulatory discussions with the Saudi Food and Drug Authority (SFDA). The company reported that the SFDA encouraged submission of a complete regulatory package for its recombinant BCG, or rBCG, to help address an ongoing shortage of traditional BCG therapy for bladder cancer patients in Saudi Arabia.
Regulatory next steps
ImmunityBio said it expects to file the full regulatory package for rBCG within the coming weeks. The SFDA conversations also covered potential label expansion for ANKTIVA in combination with checkpoint inhibitors across a range of tumor types beyond the current non-small cell lung cancer (NSCLC) indication.
ANKTIVA approvals and clinical data
ANKTIVA has previously secured two approvals in Saudi Arabia: one for BCG-unresponsive non-muscle invasive bladder cancer, and another for metastatic NSCLC in combination with checkpoint inhibitors. The latter indication received an accelerated approval in January for patients whose disease progressed following checkpoint inhibitor therapy.
ImmunityBio cited findings from its QUILT-3.055 basket trial as supporting evidence for ANKTIVA’s capacity to restore checkpoint inhibitor activity across multiple cancer types, a point that formed part of the regulatory discussions.
Manufacturing and regional presence
The company noted that rBCG is manufactured by the Serum Institute of India under an exclusive global licensing agreement announced in May. The Serum Institute’s manufacturing sites have certifications from multiple global regulatory authorities, including the WHO, EMA, and FDA, according to ImmunityBio.
To underpin its regional strategy, ImmunityBio has established a wholly owned subsidiary in Saudi Arabia and plans to open a regional office to support physicians and health systems across the Middle East and North Africa.
What remains uncertain
While the SFDA encouraged submission of the rBCG dossier and discussed broader ANKTIVA use, formal regulatory approvals for expanded ANKTIVA indications or the rBCG filing outcome remain pending. ImmunityBio’s next regulatory milestone will be the submission of the complete rBCG package within the stated timeline.