On January 14, 2026, the Saudi Food and Drug Authority granted accelerated approval for ImmunityBio’s ANKTIVA® (nogapendekin alfa inbakicept) in combination with checkpoint inhibitors for adult patients with metastatic non‑small cell lung cancer (NSCLC) whose disease had progressed after standard‑of‑care therapy. The same day the authority approved ANKTIVA® plus Bacillus Calmette‑Guérin (BCG) for BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary disease.
The approvals are the first global regulatory clearance for a subcutaneously administered IL‑15 receptor superagonist in the NSCLC space and extend ANKTIVA’s commercial reach into two high‑need oncology indications in a rapidly growing emerging market. By securing a foothold in Saudi Arabia, ImmunityBio can begin sales and reimbursement discussions, potentially generating new revenue streams and strengthening its competitive position against checkpoint inhibitors and other bladder‑cancer therapies.
The regulatory win is expected to translate into tangible business upside. ImmunityBio’s CEO Rich Adcock highlighted that the approvals will bring a much‑needed treatment option to Saudi patients who otherwise have limited alternatives. The company plans to open a regional office in Riyadh and has partnered with BioPharma Cigalah to distribute ANKTIVA® across the Middle East and North Africa, positioning the drug for broader market penetration. In the first nine months of 2025, ANKTIVA® generated $74.4 million in net product revenue, and the company is targeting a Biologics License Application submission by year‑end while enrollment in the QUILT‑2.005 trial for BCG‑naïve NMIBC patients is ahead of schedule.
Market reaction to the approvals was strong. ImmunityBio’s shares surged roughly 12 % in pre‑market trading on the day of the announcement, and the stock had already risen 28 % over the past week and 42 % year‑to‑date. Analysts have upgraded the company to a “Buy” rating and set a price target of $8.00, reflecting confidence in the expanded commercial footprint and the drug’s differentiated mechanism of action.
The company’s management emphasized the strategic importance of the Saudi market. Adcock noted that “we are pleased to bring ANKTIVA to Saudi patients with NMIBC, who otherwise have no viable options but life‑altering surgery.” He also underscored the company’s commitment to expanding its presence in the region, citing the new regional office and distribution partnership as key enablers of future growth.
Patents covering ANKTIVA® extend through 2032‑2039, providing a long‑term exclusivity window. The approvals also position the drug against established therapies such as pembrolizumab and atezolizumab in NSCLC and BCG plus intravesical chemotherapy in bladder cancer, offering a novel subcutaneous route that could improve patient convenience and adherence. While the company faces headwinds from pricing pressure in the broader oncology market, the Saudi approvals represent a significant tailwind that could offset competitive challenges and accelerate revenue growth in the coming years.
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