ImmunityBio (IBRX) shares rose 5.86% in pre-market trading to $7.23, rebounding from a prior session close of $6.83, down 2.01%. The gain followed authorization from the United Arab Emirates for ANKTIVA across both bladder and lung cancer indications in patients with limited treatment options. The decision represents ImmunityBio's broadest single regulatory approval to date and expands the therapy's international commercial footprint in two areas where treatment options remain constrained.

UAE Authorization Covers Two Cancer Indications

The Emirates Drug Establishment approved ANKTIVA in combination with BCG for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The approval encompasses carcinoma in situ, mixed tumors, and papillary-only disease without carcinoma in situ — marking the first regulatory decision to cover the full BCG-unresponsive NMIBC spectrum under a single authorization.

The regulator also approved ANKTIVA in combination with immune checkpoint inhibitors for metastatic non-small cell lung cancer (NSCLC). Eligible patients must have experienced disease progression following standard checkpoint therapy or chemotherapy combinations. Patients with actionable mutations are required to first progress after approved targeted treatments before becoming eligible for the ANKTIVA combination regimen.

With this decision, the UAE becomes the fifth regulatory jurisdiction to authorize ANKTIVA. ImmunityBio stated that the therapy now holds regulatory reach across 34 countries through various international approvals, adding another market where the company can seek adoption for both a bladder cancer and a lung cancer indication under the same national decision.

Bladder Cancer Trial Data Underpin Broad NMIBC Approval

The bladder cancer approval is supported by results from the multicenter QUILT-3.032 registrational study. In the carcinoma in situ cohort, ANKTIVA combined with BCG achieved a 71% complete response rate. Among responding patients, the median response duration reached 26.6 months during extended follow-up.

Durability data showed that 66% of responders maintained a complete response at 12 months, and 42% continued to show a complete response at 24 months. These results supported treatment across patients with carcinoma in situ and related papillary tumors.

In the papillary-only cohort, the disease-free survival rate at 12 months was 58.2%, with a median disease-free survival of 25.3 months. Additionally, 83.1% of patients avoided bladder removal at 36 months, preserving a critical organ-saving treatment option.

For clinicians and patients, the broad NMIBC authorization matters because it spans the main BCG-unresponsive disease presentations in a single regulatory action, rather than leaving separate subsets to be addressed one by one.

Lung Cancer Results Expand ANKTIVA's Applicable Market

The lung cancer authorization draws on data from the Phase 2 QUILT-3.055 study, which enrolled 79 patients whose disease had progressed after prior checkpoint inhibitor treatment. Median overall survival across the full study population reached 14.6 months after treatment initiation.

Patients with higher lymphocyte counts — representing 77% of enrolled participants — achieved a median overall survival of 16.2 months, compared with 11.8 months for patients with lower lymphocyte counts.

Reported adverse events included frequent injection site reactions, chills, fatigue, fever, and nausea. The bladder cancer study reported predominantly Grade 1 or Grade 2 treatment-related adverse events.

ImmunityBio continues to advance ANKTIVA's international rollout across additional markets, building on its widening regulatory base.