ImmunityBio Inc (NASDAQ:IBRX) rose 5.6% after announcing what it described as productive regulatory discussions with the Saudi Food and Drug Authority (SFDA) about potential product approvals in Saudi Arabia.
The company said SFDA officials encouraged it to submit a full regulatory dossier for its recombinant BCG (rBCG) therapy to help address the ongoing BCG shortage impacting bladder cancer patients in the Kingdom. ImmunityBio indicated it plans to file the complete package in the coming weeks.
The discussions also opened the door to exploring broader use of ANKTIVA in combination with checkpoint inhibitors across multiple tumor types beyond non-small cell lung cancer (NSCLC). This follows ANKTIVA’s accelerated approval in Saudi Arabia in January for metastatic NSCLC patients whose disease progressed after checkpoint inhibitor treatment.
ANKTIVA already holds two approvals in Saudi Arabia: for BCG-unresponsive non-muscle invasive bladder cancer and for metastatic NSCLC in combination with checkpoint inhibitors. The company referenced data from its QUILT-3.055 basket study highlighting ANKTIVA’s potential to restore checkpoint inhibitor activity across several cancer indications.
ImmunityBio’s rBCG is produced by the Serum Institute of India under an exclusive global licensing agreement announced in May. The Serum Institute’s facilities have been certified by multiple international regulators, including the WHO, EMA, and FDA.
As part of its regional expansion plans, ImmunityBio has formed a wholly owned subsidiary in Saudi Arabia and intends to establish a regional office to support physicians and healthcare systems throughout the Middle East and North Africa.