ImmunityBio announced that its IL‑15 superagonist ANKTIVA is now commercially available in Saudi Arabia for patients with non‑muscle invasive bladder cancer and metastatic non‑small cell lung cancer. The launch follows a partnership with Biopharma and Cigalah Healthcare, announced in February 2026, which will handle distribution across the Middle East and North Africa. This marks the first time ANKTIVA has been approved and launched outside the United States, expanding the company’s international footprint and opening a new market for its flagship product.
The Saudi Food and Drug Authority approved ANKTIVA for both indications in January 2026, with the lung‑cancer approval being the first global approval outside the United States. The approval was granted under an accelerated pathway, underscoring the urgency of addressing unmet needs in the region’s high‑burden lung‑cancer population.
Biopharma and Cigalah Healthcare, the distributors for the MENA region, were named in a February 2026 announcement. The partnership leverages the distributors’ established networks to expedite market entry, a key element of ImmunityBio’s strategy to bring ANKTIVA to patients worldwide.
Financially, ImmunityBio reported Q1 2026 net product revenue of $44.2 million, a 168% year‑over‑year increase, and full‑year 2025 net product revenue of $113 million, a 700% jump from 2024. The company ended Q1 2026 with approximately $380.9 million in cash, positioning it to support continued growth and regulatory expansion.
In April 2026, a securities class action lawsuit was filed against ImmunityBio, alleging that the company and its chairman concealed drug limitation risks. The lawsuit followed an FDA warning letter that identified “false or misleading” promotional communications about ANKTIVA, highlighting regulatory and legal challenges that accompany the product’s expansion.
Richard Adcock, President and CEO, said, “Thanks to our strategic partnership with Biopharma and Cigalah Healthcare, and despite a fluid situation in the region, we have been able to bring this innovative cancer treatment to patients ahead of the deadline we announced in February.” He added, “We continue to work with the same level of diligence and commitment to expand access to ANKTIVA for eligible patients across the Middle East and North Africa.” Patrick Soon‑Shiong, Founder and Executive Chairman, remarked, “This approval represents a significant step forward for lung cancer patients in the Kingdom of Saudi Arabia and a meaningful milestone that we hope will pave the way toward additional approvals across a region where lung cancer claims far too many lives each year.” He also noted, “This combination of ANKTIVA plus a checkpoint inhibitor serves as a foundational backbone to immunotherapy 2.0, enabling activation of the complex immune system through subcutaneous outpatient therapy.”
The MENA region faces a high burden of bladder and lung cancers, with limited treatment options. ANKTIVA’s launch addresses a critical unmet need, positioning ImmunityBio to capture a sizable share of a growing market. The company’s first international launch signals a broader strategy to expand its commercial reach beyond the United States, potentially unlocking new revenue streams and reinforcing its competitive position in the immunotherapy space.
The commercial launch in Saudi Arabia demonstrates ImmunityBio’s ability to navigate regulatory processes and establish distribution partnerships in new markets. By securing approvals for both indications and partnering with established regional distributors, the company has laid the groundwork for accelerated growth in the MENA region. The launch also enhances the company’s global portfolio, supporting its long‑term strategy to bring ANKTIVA to patients worldwide and to capitalize on the expanding demand for innovative cancer therapies.
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