Shares of ImmunityBio experienced a significant rally on Friday, climbing 10.5% in afternoon trading. The surge followed the company's announcement that it has successfully engineered a scalable manufacturing process for its natural killer (NK) cell therapy platform. The stock traded at $8.64 as of 1:21 p.m. EDT, representing an $0.82 gain from the previous session's close.
Manufacturing Breakthrough and Clinical Context
The newly detailed process represents a critical step for the biotech firm as it seeks to build a reliable manufacturing operation beyond its current focus on the bladder cancer therapy Anktiva. According to the company, a single cell collection can now generate up to 5 billion activated NK cells—immune cells engineered to target tumors—sufficient to produce 8 to 10 treatment doses. The final product can be ready in as few as 12 days.
In early combination trials, ImmunityBio enrolled 74 subjects across its manufacturing programs. Of these, 10 cancer patients received the cell therapy without experiencing any serious adverse events. Founder Patrick Soon-Shiong characterized the advancement as potentially enabling a "World Bank of Natural Killer Cells," highlighting its future scalability.
Regulatory Momentum for Anktiva
This manufacturing update builds upon recent regulatory progress for Anktiva. Earlier in the week, ImmunityBio disclosed that the U.S. Food and Drug Administration (FDA) had accepted its resubmitted supplemental Biologics License Application (sBLA). This application seeks to expand the drug's label for use alongside Bacillus Calmette-Guérin (BCG) in patients with BCG-unresponsive non-muscle invasive bladder cancer, including those with papillary tumors.
Notably, the FDA requested additional efficacy data but did not mandate a new clinical trial, potentially streamlining the path to approval. This development follows the drug's recent conditional marketing authorization across 33 countries, including the United Kingdom, Saudi Arabia, and the European Union, granted less than a month prior.
Financial Performance and Competitive Landscape
The company's latest filings reveal a period of rapid commercial growth. Net product revenue for Anktiva skyrocketed to $113 million in 2025, a figure approximately seven times higher than the previous year. CEO Richard Adcock emphasized "disciplined execution" as the company prepares for an initial international market push.
However, the competitive environment is intensifying. Rival Gilead announced plans this year to quadruple its cell-therapy cancer treatment capacity by 2026 through manufacturing upgrades. Furthermore, Johnson & Johnson secured U.S. approval last September for TAR-200 (marketed as Inlexzo), a treatment targeting high-risk bladder cancer.
Persistent Risks and Financial Position
Despite the positive developments, significant risks remain. The European authorization is conditional, requiring ongoing data collection and annual re-approvals. ImmunityBio itself cautioned that scaling up cell therapy production, automating processes, managing supply chains, and clearing regulatory hurdles could encounter obstacles.
Financially, the company continues to report substantial losses. Its net loss for the full year 2025 was $351.4 million, an improvement from the prior year's $413.6 million loss but still considerable. As of the end of December, ImmunityBio held $242.8 million in cash, cash equivalents, and marketable securities.
Investor attention now turns to the FDA's pending decision on the papillary bladder cancer filing and whether the newly announced manufacturing process can generate compelling data beyond early-stage safety results. The market's positive reaction reflects optimism for the platform's potential, but the long-term outlook remains intertwined with regulatory outcomes and the company's ability to navigate a complex financial and competitive landscape.
