ImmunityBio Shares Surge on Expanded Cancer Treatment Guidelines

A significant update to U.S. cancer treatment protocols has substantially broadened the potential patient population for ImmunityBio’s flagship immunotherapy. The National Comprehensive Cancer Network (NCCN) has revised its guidelines for bladder cancer, now explicitly recommending the use of ANKTIVA for a much larger group of individuals.

Revised Protocol Unlocks Major Market

The latest NCCN guidelines, version 1.2026, now include a Category 2A recommendation for ANKTIVA, in combination with BCG, to treat patients with papillary non-muscle invasive bladder cancer (NMIBC). This subgroup represents approximately 70% of the roughly 60,000 new cases diagnosed annually in the United States. Previously, the recommendation was limited to patients with carcinoma in situ (CIS).

This change is a pivotal commercial development, as NCCN guidelines serve as a critical reference for physicians and payers in determining treatment pathways and reimbursement decisions, even in the absence of formal FDA approval for a specific indication.

Stock Responds Positively to News

Market reaction to the guideline expansion was immediately positive. In pre-market trading on March 17, ImmunityBio’s stock price advanced by nearly 6.8% to $8.77, following a previous close at $8.21.

The clinical basis for the NCCN update stems from data from the QUILT-3.032 clinical trial (Cohort B), which demonstrated durable response rates in patients with exclusively papillary disease.

Should investors sell immediately? Or is it worth buying ImmunityBio?

Regulatory and Financial Landscape

While the guideline shift is impactful, formal FDA approval for this specific papillary indication remains pending. ImmunityBio submitted a supplemental Biologics License Application (sBLA) on March 9, 2026. The FDA acknowledged the submission and has requested additional efficacy and long-term data, though it did not mandate new clinical trials.

ANKTIVA already holds a permanent J-Code (J9028) from the Centers for Medicare & Medicaid Services and has insurance coverage for over 100 million insured individuals in the U.S. The decision to extend reimbursement to the papillary indication, however, rests with individual payers.

From a financial perspective, ImmunityBio remains in a high-investment phase. For the last twelve months, the company reported revenue of $113 million against a net loss of $351 million. Its gross margin of 99.3% reflects the premium pricing of its therapeutic products, but the path to sustained profitability is still unfolding. The company reported liquid assets of approximately $243 million.

Strong Performance and Global Strategy

ImmunityBio’s equity has been one of the standout performers in the biotech sector this year, boasting a year-to-date gain of approximately 315%. Its three-year return stands at an impressive 482%, although the share price remains down about 75% over a five-year horizon.

Internationally, the company is executing an expansion strategy. A distribution partnership with Accord Healthcare and the establishment of a new subsidiary in Dublin are designed to commercialize ANKTIVA across 30 countries. Concurrently, ImmunityBio is in discussions with the Saudi Food and Drug Authority (SFDA) regarding a submission for recombinant BCG and is exploring additional indications in combination with checkpoint inhibitors.