ImmunityBio launches ANKTIVA in Saudi Arabia after accelerated lung cancer approval
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.
ImmunityBio has now commercially launched its immunotherapy ANKTIVA in Saudi Arabia for approved bladder and metastatic non-small cell lung cancer indications, with distribution supported by regional partners Biopharma and Cigalah Healthcare and its local subsidiary. Among recent developments, the Saudi Food and Drug Authority’s accelerated approval of ANKTIVA plus checkpoint inhibitors for metastatic non small cell lung cancer is especially relevant. The new commercial availability in Saudi Arabia now connects that regulatory decision to actual treated patients, providing an early read on physician adoption and partner execution in MENA.
This marks one of the first commercial rollouts of ANKTIVA for both bladder and lung cancer in the Middle East and North Africa, a region facing a rapidly growing cancer burden and rising demand for additional treatment options. The Saudi launch adds another real world test of the thesis that ANKTIVA can move from a single core bladder cancer product toward a broader global franchise, including lung cancer.
The company successfully remediated its processes after receiving a Complete Response Letter from the FDA in 2023 due to manufacturing deficiencies, leading to FDA approval of ANKTIVA for BCG-unresponsive non-muscle invasive bladder cancer in April 2024. Preliminary product revenue for 2025 reached $113 million, representing a 700% year-over-year increase. As of February 19, 2026, the stock was trading near $8.68, with market capitalization at approximately $8.5 billion.
Despite the revenue growth, the company reported a quarterly net loss of approximately $92 million in its most recent filing, with a cash runway of roughly $242.8 million as of early 2026. Investors should also be aware that the key near term catalyst remains regulatory and commercial progress in larger markets, while the biggest risk is that ANKTIVA uptake and label expansion stall, leaving the business heavily dependent on one drug and straining a company that is still unprofitable.