ImmunityBio Advances Clinical Pipeline with New Trials and Regulatory Progress

ImmunityBio continues to make significant strides in expanding its immunotherapy development portfolio. The biotech firm's shares have experienced notable volatility recently, influenced by a series of clinical data updates and progress toward broadening the label for its flagship product, ANKTIVA.

Market analysts have shown growing confidence in the company's outlook. In January 2026, several firms raised their price targets for ImmunityBio. HC Wainwright increased its target to $10 from $8, while BTIG lifted its target to $9 from $6. Piper Sandler also raised its target, moving to $7 from $5. The latter firm highlighted a dramatic surge in revenue, noting that U.S. net sales for ANKTIVA grew approximately 700% year-over-year in 2025 to reach $113 million. Projections for 2026 anticipate sales of around $180 million.

The commercial foundation for ANKTIVA is strengthening geographically. The therapy is now approved not only in the United States (since April 2024) but also in the United Kingdom and Saudi Arabia for BCG-resistant bladder cancer with carcinoma in situ, with potential European Union approval on the horizon.

A Novel Chemotherapy-Free Combination Enters Phase 2

A key recent development is the initiation of the ResQ215B trial. This Phase 2 study, which began on February 2, 2026, is investigating a treatment for indolent B-cell non-Hodgkin lymphomas. The approach is distinctive because it combines three agents without requiring prior chemotherapy—a marked departure from conventional CAR-T cell therapies.

The regimen consists of CD19 t-haNK (an off-the-shelf CAR-NK cell therapy), ANKTIVA (an IL-15 superagonist), and Rituximab (an anti-CD20 antibody). The trial is enrolling adult patients with CD19⁺/CD20⁺ positive indolent NHL who have relapsed or are refractory after at least two prior lines of therapy.

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Phase 1 Data Provides Encouraging Foundation

This new clinical effort builds upon promising early-stage results. In a Phase 1 study involving four patients with Waldenström macroglobulinemia treated with CD19-CAR-NK cells plus Rituximab (without lymphodepletion), clinical disease control was achieved in all participants. Two of those patients attained complete remissions, which were ongoing for 7 and 15 months, respectively, at the time of data publication.

Regulatory Pathway for Bladder Cancer Indication

In parallel, ImmunityBio is pursuing a label expansion for ANKTIVA in papillary bladder cancer. The company reported in January 2026 that, following a Type-B End-of-Phase meeting, the U.S. Food and Drug Administration (FDA) requested additional information for a potential resubmission. Notably, the agency did not ask for new clinical studies.

The supporting data comes from the Phase 2/3 QUILT-3.032 trial, which enrolled 80 patients. Results demonstrated a 12-month disease-free survival rate of 58.2% and a notably high 36-month disease-specific survival rate of 96%. These findings have been published in the Journal of Urology.