A Surge of Catalysts and Volatility for ImmunityBio

ImmunityBio has entered 2026 with significant momentum, propelled by a confluence of fresh clinical data, key regulatory communications, and international approvals. This flurry of activity has been mirrored by dramatic swings in the company’s share price, which experienced a powerful rally followed by a notable pullback. The interplay between scientific progress and market turbulence is now a central theme for investors.

Stock Performance: A Rollercoaster Ride

The accumulation of clinical and regulatory news in January triggered extraordinary price action for ImmunityBio shares. Despite a recent weekly correction of approximately 14%, the stock remains up nearly 195% year-to-date, following a 30-day surge of around 192%. Over a twelve-month period, the gain exceeds 100%.

Closing recently at $5.95, the equity trades about 19% below its 52-week high of $7.34, reached on January 22. However, it maintains a position more than 250% above its low from May 2025. The current price sits well above key moving averages, such as the 200-day line at $2.35, underscoring the strength of the prior advance. Market dynamics are marked by extreme volatility, with the annualized 30-day measure near 168%. A 14-day RSI reading of 48.3 suggests the stock is in a neutral state following its rally and subsequent consolidation.

Glioblastoma Data: Survival Signal and Immune Recovery

On January 23, ImmunityBio released updated Phase 2 data from its QUILT-3.078 trial for patients with recurrent glioblastoma. The investigational regimen is a chemotherapy-free combination therapy.

A critical data point is that the primary endpoint, median overall survival (OS), has not yet been reached. As of January 22, 19 of the 23 enrolled patients remain alive. Among 14 evaluable patients, the longest documented survival time since tumor relapse has extended to 12 months and continues. The company notes that median OS in contemporary studies for recurrent glioblastoma typically ranges from only six to nine months, suggesting the unreached median may indicate a potential survival benefit, though mature data is required for definitive conclusions.

A notable immunological finding was the recovery of lymphocyte counts. Patients began the study with pronounced lymphopenia. The mean absolute lymphocyte count (ALC) was 0.9 x 10³/µL at baseline. Following treatment with ANKTIVA plus a CAR-NK therapy, the mean ALC increased to at least 1.4 x 10³/µL within one treatment cycle (p < 0.001). This statistically significant improvement was reportedly sustained for over 20 weeks. For this heavily pre-treated, immunocompromised population, stabilized immune function is considered a prerequisite for sustained tumor control.

The safety profile was also highlighted. Across 41 treated glioblastoma patients (from the study and compassionate use), three treatment-related serious adverse events occurred. Notably, no cases of cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome (ICANS) were reported—a significant detail for complex immunotherapy combinations.

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

Bladder Cancer: Regulatory Pathway and Long-Term Evidence

In parallel, ImmunityBio is pursuing a label expansion for ANKTIVA in bladder cancer. The company reported on January 20 that it held a Type B End-of-Phase meeting with the U.S. FDA regarding a supplemental Biologics License Application (sBLA) for BCG-unresponsive papillary disease.

The agency requested additional information but did not mandate new clinical studies, keeping the pathway for a potential resubmission open. ImmunityBio plans to provide the requested data within 30 days.

This effort is supported by long-term data from the QUILT-3.032 study, published in the Journal of Urology. In patients with papillary bladder cancer, the three-year cancer-specific survival rate was 96%, with a bladder preservation rate exceeding 80%. These figures bolster the company’s regulatory rationale.

International Growth and Additional Trial Milestones

The company’s global regulatory footprint is expanding. On January 14, Saudi Arabia’s drug authority approved ANKTIVA for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. This adds to existing approvals in the United States and United Kingdom, as well as a conditional approval in the European Union.

For BCG-naïve bladder cancer patients, ImmunityBio reported on January 16 that enrollment in the pivotal, randomized QUILT-2.005 trial is over 85% complete. Study completion is expected by the second quarter of 2026, with a planned BLA submission by the end of 2026. An interim analysis requested by the FDA indicated a statistically significant longer duration of complete responses for ANKTIVA plus BCG versus BCG alone—a central efficacy measure for this patient group.

Key Data Points and Forward Agenda

• Glioblastoma (QUILT-3.078): Median overall survival not yet reached; 19 of 23 patients alive; longest survival post-relapse currently at 12+ months.
• Immune Function: Significant, sustained lymphocyte count recovery with ANKTIVA + CAR-NK therapy.
• Safety Profile: Three treatment-related serious adverse events among 41 GBM patients; no reported cases of CRS or ICANS.
• Papillary Bladder Cancer (sBLA): FDA requested additional data but no new studies; company plans submission within 30 days.
• Long-Term Data (QUILT-3.032): 96% cancer-specific survival and >80% bladder preservation at three years.
• Saudi Arabia: ANKTIVA approved for BCG-unresponsive NMIBC with CIS on January 14.
• BCG-Naïve Patients (QUILT-2.005): Enrollment >85% complete; study finish targeted for Q2 2026; BLA submission aimed for late 2026; interim analysis shows longer complete remission duration with ANKTIVA + BCG.
• Market Context: Powerful January rally followed by correction, accompanied by very high volatility.

The coming months will focus on data maturation and regulatory steps. Clinically, further maturation of the glioblastoma data will be crucial to substantiate the early survival signal. Regulatorily, key milestones in bladder cancer are anticipated, from the near-term FDA data submission to the targeted BLA filing for BCG-naïve patients in late 2026. The company is also scheduled to present its data and strategy at the “Stand Up To Cancer Summit” on January 31, 2026.