IBRX and the BCG Shortage: A 2026 Development Closely Watched by Investors

ImmunityBio Navigates BCG Shortage and Expands Anktiva Use

ImmunityBio is leveraging the ongoing shortage of Bacillus Calmette-Guérin (BCG) to accelerate the adoption of its flagship immunotherapy, Anktiva, in the treatment of non-muscle invasive bladder cancer (NMIBC). This unique situation is driving new patterns of demand within the NMIBC landscape.

Looking ahead to 2026, investors will have several clear milestones to monitor, which will shed light on the rate and sustainability of Anktiva’s uptake, as well as the company’s progress in expanding internationally.

BCG Shortage Reshapes Market Dynamics for IBRX

The persistent lack of BCG is more than a temporary disruption—it’s a structural issue that is changing how urology clinics source and sequence therapies. ImmunityBio is capitalizing on this environment by creating new access channels, strengthening Anktiva’s position in NMIBC, and fostering deeper relationships with urologists at critical decision points. This approach encourages repeat prescribing and long-term engagement.

Growth of ImmunityBio’s Expanded Access Program

The FDA-approved expanded access initiative for recombinant BCG has grown to include around 100 active or soon-to-be-active sites, treating over 500 patients as of January 2026. The delivery of several thousand doses demonstrates meaningful throughput in a market constrained by limited supply. By establishing a presence in community settings, ImmunityBio is building a unique access pathway that differs from traditional commercial launches, potentially paving the way for broader adoption of Anktiva in combination with recombinant BCG as experience and evidence accumulate.

ImmunityBio, Inc. Price and Consensus

Upcoming FDA Milestone in March 2026

An important FDA meeting is scheduled for March 2026 to discuss the regulatory path for the recombinant BCG program. This event is a significant catalyst, as it will clarify regulatory expectations and potentially adjust development timelines, providing investors with a concrete checkpoint.

Clinical Data Underpins Demand for Anktiva

Physician confidence is central to demand, and ImmunityBio highlights strong NMIBC results to support continued engagement. In patients with BCG-unresponsive carcinoma in situ (with or without papillary tumors), the combination of Anktiva and BCG achieved a 71% complete response rate, with durable effects lasting beyond 53 months and bladder preservation confirmed at 36 months.

This combination of efficacy, durability, and organ preservation helps explain why urologists remain interested as access expands. The company is also targeting BCG-naïve NMIBC carcinoma in situ as the next growth area, with interim data showing improved 6- and 9-month complete response rates for Anktiva plus BCG. An FDA submission is planned before the end of 2026, with pivotal trial results expected in the fourth quarter of that year.

International Expansion Broadens ImmunityBio’s Reach

ImmunityBio is moving beyond its U.S. foundation, with the European Commission granting conditional marketing approval for Anktiva plus BCG in February 2026 for the same NMIBC indication as in the U.S. The company’s European rollout focuses on securing reimbursement country by country, prioritizing the largest markets, with Germany expected to launch first in 2026 through Accord Healthcare’s network across 31 European nations.

Additionally, ImmunityBio has received approvals in Saudi Arabia and is preparing to begin shipments, further extending its global footprint as European reimbursement processes unfold.

Scaling and Execution: Key Priorities for 2026–2027

As ImmunityBio’s programs and international presence grow, operational complexity increases. The company is addressing this by deploying the NANT Leonardo AI-robotic platform to automate the production of natural killer and CAR-NK cells, aiming to reduce costs and ensure consistent, traceable manufacturing.

Furthermore, the askIB AI initiative is being used across research, manufacturing, and operations to speed up decision-making as the company scales. These efforts are designed to support ImmunityBio’s anticipated global expansion through 2026 and 2027, even as operational challenges intensify.

Risks Investors Should Monitor

• Strong competition in the oncology space
• Heavy reliance on Anktiva as the main growth driver
• Uncertainty around the timing of international revenue growth, which depends on reimbursement and logistics in different regions

Major pharmaceutical companies like Merck and Johnson & Johnson already have a strong presence in bladder and urothelial cancer, influencing treatment standards as new therapies enter the market.

Ultimately, the investment case for ImmunityBio is anchored in measurable milestones: continued U.S. product sales growth through late 2025, progress with the European launch and reimbursement, FDA updates for recombinant BCG, and key clinical and regulatory achievements expected by the end of 2026.

ImmunityBio’s Zacks Rank

Currently, ImmunityBio holds a Zacks Rank #3 (Hold).

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