ImmunityBio (IBRX) shares rose 5.86% in pre-market trading to $7.23, rebounding from a 2.01% decline to $6.83 at the previous close. The move followed authorization from the Emirates Drug Establishment for ANKTIVA covering both bladder and lung cancer indications, marking the company's most expansive regulatory approval to date and extending the therapy's global market reach.

The UAE decision adds to a growing international footprint for ANKTIVA, which ImmunityBio says now holds regulatory authorization across 34 countries through various approvals. For a company building around a single therapy platform, that kind of multi-country access can matter because it broadens where the drug may be available and where commercial execution can progress, while still depending on local regulatory and launch steps.

UAE Grants Dual Cancer Indication Approval

The Emirates Drug Establishment authorized ANKTIVA in combination with BCG for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The approval covers the full disease spectrum, including carcinoma in situ cases, mixed tumor presentations, and papillary-only disease without carcinoma in situ. According to ImmunityBio, this is the first regulatory framework to address the complete BCG-unresponsive NMIBC disease spectrum within a single authorization.

Regulators also approved ANKTIVA combined with immune checkpoint inhibitors for metastatic non-small cell lung cancer. Eligibility requires documented disease progression following conventional checkpoint therapy or chemotherapy combination regimens. Patients with actionable genetic mutations must demonstrate progression after approved targeted therapies before qualifying for treatment.

The UAE becomes the latest jurisdiction to authorize ANKTIVA distribution. ImmunityBio reports that the therapy now holds regulatory authorization across 34 countries through various international approvals.

Bladder Cancer Clinical Evidence

The bladder cancer approval is supported by data from the multicenter QUILT-3.032 registrational trial. In the carcinoma in situ patient cohort, the ANKTIVA plus BCG regimen achieved a 71% complete response rate. Among responding patients, the median response duration was 26.6 months during extended monitoring.

The trial data showed that 66% of responding patients maintained complete response status at 12 months, with 42% continuing to show complete response at 24 months. These outcomes demonstrated therapeutic efficacy across patients with carcinoma in situ and associated papillary tumor formations.

In the papillary-only patient cohort, the disease-free survival rate at 12 months was 58.2%, with a median disease-free survival of 25.3 months. At 36 months, 83.1% of participants had avoided cystectomy, preserving bladder function.

Lung Cancer Trial Results

The lung cancer clearance is based on Phase 2 QUILT-3.055 trial findings. The study enrolled 79 participants who had experienced disease progression after prior checkpoint inhibitor therapy. Median overall survival across the full cohort reached 14.6 months following treatment initiation.

Participants with elevated lymphocyte levels—a subgroup comprising 77% of enrollees—achieved a median overall survival of 16.2 months, compared with 11.8 months for those with reduced lymphocyte counts.

Reported adverse events included injection site reactions, chills, fatigue, fever, and nausea. The bladder cancer trial predominantly documented Grade 1 or Grade 2 treatment-associated adverse events.

ImmunityBio continues to advance ANKTIVA's international launch strategy across additional territories with its expanded regulatory foundation.