ImmunityBio revealed preliminary net product revenue for Anktiva reached $113 million in 2025, a 700% increase from the $15 million recorded in 2024. The company’s stock jumped 30.8% on January 15, 2026, as investors responded to the blockbuster performance of its lead bladder cancer therapy. Management attributed the surge to expanded commercial footprint in U.S. community oncology practices and enhanced reimbursement coverage. Remarkably, Anktiva prescriptions increased by 450% year-over-year, with over 2,300 patients treated by year end. Despite a long-term downward trend since its 2015 IPO, the recent execution has restored confidence among institutional and retail shareholders.

In January 2026, the Saudi Food and Drug Authority granted two accelerated approvals for Anktiva. The first covers its use with checkpoint inhibitors for adult patients with metastatic non-small cell lung cancer whose disease progressed after standard therapy. The second approval permits Anktiva plus Bacillus Calmette-Guérin for Bacillus Calmette-Guérin–unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary disease. These regulatory milestones extend Anktiva’s commercial reach into the Middle East, where ImmunityBio projects initial annual sales of $20 million to $25 million. The approvals bolster the company’s international expansion strategy and support its forecast of achieving $350 million in global product revenue by 2027.

ImmunityBio presented interim Phase II data showing a 38% overall response rate for Anktiva combined with pembrolizumab in second-line metastatic non-small cell lung cancer. Median progression-free survival extended to 7.4 months versus 4.8 months historical control, and 62% of responders remained progression-free at six months. Safety data were consistent with known profiles for each agent, with Grade 3 or higher adverse events occurring in 28% of patients. These encouraging results underpin a planned Phase III registration trial, slated to initiate in Q2 2026 across North America and Europe, engaging approximately 300 patients. Investors view this as a de-risking step toward label expansion and longer-term revenue diversification.