NEW YORK, March 13, 2026, 1:37 PM EDT
- ImmunityBio shares jumped roughly 10.5% as of 1:21 p.m. EDT, following news that the company had detailed a scalable NK-cell manufacturing process. ImmunityBio
- This latest step builds on the FDA resubmission progress for papillary bladder cancer, and also marks Anktiva’s footprint now reaching 33 countries. ImmunityBio
- The rally hasn’t erased concerns around regulation, manufacturing, or the state of company balance sheets. ImmunityBio
ImmunityBio stock jumped 10.5% Friday, lifted by news the company wrapped up manufacturing engineering for its natural killer cell therapy platform. Shares traded at $8.64 as of 1:21 p.m. EDT, marking an $0.82 gain over Thursday’s close. ImmunityBio
This move is significant for ImmunityBio, as it works to establish a steady manufacturing operation beyond its current focus on the bladder-cancer therapy Anktiva. At the same time, the company is urging regulators to expand Anktiva’s label. The latest development landed four days after ImmunityBio announced the FDA had accepted its resubmitted application targeting papillary bladder tumors. Less than a month earlier, European authorities cleared the way for Anktiva in 33 countries. ImmunityBio
ImmunityBio on Friday reported that a single cell collection can generate as many as 5 billion activated NK cells—these are the immune cells that target tumors—enough to create 8 to 10 doses, with the final product ready in as little as 12 days. Across its manufacturing programs and an early combo trial, the company enrolled 74 subjects. Of those, 10 cancer patients got the cell therapy without any serious adverse events. Founder Patrick Soon-Shiong described the advance as something that “opens the possibility” for a “World Bank of Natural Killer Cells.” ImmunityBio
ImmunityBio said this week the FDA had received its supplemental biologics license application, or sBLA, for Anktiva paired with Bacillus Calmette-Guérin (BCG) in patients with BCG-unresponsive non-muscle invasive bladder cancer and papillary tumors. The supplemental filing aims to expand the use of an already approved biologic. According to ImmunityBio, the FDA requested more efficacy data but did not call for a new clinical trial. ImmunityBio
The numbers from ImmunityBio’s latest filing underline a stretch of rapid sales growth and regulatory wins. Net product revenue for Anktiva shot up to $113 million in 2025—roughly seven times higher than last year. The company said the drug is now cleared for use in the U.S., U.K., Saudi Arabia and across the EU, hitting 33 countries in total. “Disciplined execution” remains the company’s focus as it gears up for an initial push into international markets, according to CEO Richard Adcock. SEC
Competition’s heating up. Gilead announced this year it’s aiming to boost cell-therapy cancer treatment capacity fourfold by 2026 following upgrades on the manufacturing side. Johnson & Johnson, for its part, picked up U.S. approval for TAR-200—in the market as Inlexzo—last September, targeting high-risk bladder cancer. Reuters
Still, there’s no assured payday here. What Europe handed out is a conditional marketing authorization—early access, but tied to more data collection and yearly re-approvals. ImmunityBio also cautioned that scaling up cell therapy, automating production, managing supply, and clearing regulatory hurdles could all hit snags. SEC
ImmunityBio keeps burning through cash. The company’s net loss for the full year hit $351.4 million in 2025—less than last year’s $413.6 million, but still hefty. They closed out December holding $242.8 million in cash, equivalents, and marketable securities. Next up: FDA’s decision on the papillary filing, and whether Friday’s manufacturing efforts generate data past early-stage safety. SEC
