New York, Jan 16, 2026, 10:16 EST — Regular session
- ImmunityBio shares surged early on following fresh news about their pivotal bladder-cancer trial
- The company has flagged $113 million in preliminary net product revenue from ANKTIVA for 2025
- The company said a Saudi regulator gave accelerated approvals for uses in lung and bladder cancer
ImmunityBio shares surged roughly 16.5% to $4.60 Friday morning, building on a strong rally after the biotech reported better-than-expected sales momentum for its main cancer drug. The company also detailed plans for a label-expansion effort. Trading volume exceeded 56 million shares, with the stock reaching an intraday peak of $5.20.
This move is crucial as ImmunityBio aims to show its commercial potential goes beyond just clinical promise. Investors want clear evidence that ANKTIVA’s launch is picking up steam and that regulators might expand approvals beyond its current U.S. bladder cancer indication.
The company is also focusing on a bigger opportunity: first-line bladder cancer patients who haven’t yet been treated with BCG. If approved, this could significantly expand its target market. BCG, the standard immune-based bladder treatment, has been plagued by supply shortages, causing ongoing issues for clinics.
On Friday, the company announced that enrollment in its randomized QUILT-2.005 trial for BCG-naïve non-muscle-invasive bladder cancer has surpassed 85%, aiming to complete recruitment by Q2 2026. It plans to submit a biologics license application — the FDA’s marketing-approval filing — by the end of 2026. An FDA-requested interim analysis revealed a longer duration of complete response with ANKTIVA plus BCG compared to BCG alone, including a statistically significant difference at nine months (p=0.0455). “The interim analysis is encouraging,” said Patrick Soon-Shiong, ImmunityBio’s founder and executive chairman. Nasdaq
ImmunityBio on Thursday announced preliminary net product revenue of roughly $113.0 million for the year ended Dec. 31, 2025—a surge of about 700% from the previous year. The company also reported approximately $38.3 million in revenue for the fourth quarter. Cash, cash equivalents, and marketable securities stood at an estimated $242.8 million at year-end, though the company warned these numbers are preliminary and may be revised in the audited annual report. “We delivered strong quarter-over-quarter revenue growth, reflecting accelerating adoption of ANKTIVA,” CEO Richard Adcock said. ImmunityBio
The company is also capitalizing on fresh regulatory developments abroad. In an SEC filing dated Jan. 14, ImmunityBio revealed that Saudi Arabia’s Food and Drug Authority granted accelerated approval for ANKTIVA combined with immune checkpoint inhibitors to treat metastatic non-small cell lung cancer following standard therapy. The agency also approved ANKTIVA plus BCG for BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ.
ImmunityBio announced that Saudi Arabia granted accelerated approval for its lung-cancer treatment, based on clinical data showing a link between lymphocyte recovery and patient survival. A confirmatory randomized trial is currently recruiting. The company also revealed plans to establish a regional office in the Kingdom and partner with Biopharma Cigalah for commercial distribution. “This approval represents a significant step forward for lung cancer patients in the Kingdom of Saudi Arabia,” said Soon-Shiong. ImmunityBio
Checkpoint inhibitors — a drug class that features some of the biggest names in pharma — form a cornerstone of lung-cancer treatment. ImmunityBio’s Saudi approval links ANKTIVA to that established group. Still, this lung-cancer indication is currently approved only abroad, so investors are expected to continue distinguishing between “approved” and “proven at scale.”
That said, this trade isn’t without risks. Preliminary revenue figures could be adjusted once audited results roll in, and accelerated approvals often come with conditions attached. If confirmatory trials fall short or deadlines slip, sentiment could sour quickly. Much of the upside also hinges on consistent demand and smooth manufacturing and supply chain performance.
Traders are now turning their attention to the company’s audited 2025 annual report (Form 10-K) for insight into cash burn and how sustainable ANKTIVA’s revenue trend appears. After that, all eyes will be on whether QUILT-2.005 meets its enrollment deadline in the second quarter of 2026 and keeps the year-end 2026 FDA filing on schedule.
