ImmunityBio Reports Expanded ANKTIVA Approval And Global Market Expansion Across 35 Countries

Label Expansion and Global Progress

• FDA Expanded Approval: On October 14, 2026, the U.S. Food and Drug Administration (FDA) approved our supplemental Biologics License Application (sBLA) expanding the approved indication for ANKTIVA® in combination with Bacillus Calmette-Guérin (BCG) to include adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This expanded indication now includes adult patients with BCG-unresponsive NMIBC with high-grade papillary-only tumors.
• BCG Naïve Primary Endpoint Met: In November 2026, we reported that the primary endpoint for Cohort A was met in the randomized QUILT-2.005 trial, and we remain on track to submit an sBLA to the FDA in the fourth quarter of 2026 for ANKTIVA in combination with BCG in patients with BCG-naïve NMIBC.
• ANKTIVA Approval in Israel: In November 2026, we announced approval in Israel of ANKTIVA in combination with BCG for BCG-unresponsive NMIBC with CIS, with or without papillary tumors, bringing the number of global approvals to 35.
• First Patient Treated in Europe: In November 2026, we announced that the first patients in Europe have received treatment with ANKTIVA in combination with BCG for BCG-unresponsive NMIBC with CIS, with or without papillary tumors, expanding access to ANKTIVA across the region.

92% Nine Month Revenue Growth

• Q3 2026 net product revenue of $48.7 million, up 53% year-over-year, driven by continued adoption among U.S. urologists and strong market access
• 2026 year-to-date net product revenue of $143.6 million, up 92% year-over-year
• Over $334.3 million cash and cash equivalents, and marketable securities on hand as of September 30, 2026

ImmunityBio, Inc. ((IBRX), a commercial-stage immunotherapy company, today announced continued global expansion, expanded FDA approval, and financial results for the third quarter ended September 30, 2026.

ImmunityBio continued to advance a broad clinical pipeline spanning bladder cancer, non-small cell lung cancer, and hematologic malignancies with expanded FDA approval and global expansion of ANKTIVA in nonmuscle invasive bladder cancer (NMIBC). ANKTIVA is now approved or authorized in six regulatory jurisdictions, expanding its global footprint to 35 countries, while multiple ongoing clinical and regulatory programs continue to support the Company’s long-term growth strategy.

The Company advanced several key regulatory and clinical programs across its immunotherapy pipeline. It received an expanded label for ANKTIVA in combination with BCG to include adults with BCG-unresponsive NMIBC, including those with papillary-only tumors. In addition, Cohort A of the randomized QUILT-2.005 trial evaluating ANKTIVA in combination with BCG in patients with BCG-naïve NMIBC met its primary endpoint. The Company also initiated its first sales in Europe in early Q4 and obtained approval in Israel in collaboration with its partner, Rafa Laboratories Ltd.

In this quarter (October 2026), ImmunityBio received FDA approval for expanded use of ANKTIVA plus BCG in subjects with BGC-unresponsive nonmuscle invasive bladder cancer (NMIBC). This expanded FDA approval has already been authorized by the Emirates Drug Establishment (United Arab Emirates) and the Company will now pursue global filings for this expanded indication.

The company today announced that the primary endpoint for BCG naïve nonmuscle invasive bladder (NMIBC) cancer has been reached in subjects receiving ANKTIVA plus BCG versus those receiving BCG alone. With this positive result the supplemental BLA (sBLA) for BCG naïve NMIBC patients is on track for submission in this quarter.

Global expansion and operational implementation of the launch of ANKTIVA plus BCG in BCG unresponsive NMIBC continues with the approval of ANKTIVA plus BCG in NMIBC in Israel and the first commercial dose administered in Europe.

On October 16, 2026, The Journal of Urology published long-term outcomes from our Phase 2/3 QUILT-3.032 trial of ANKTIVA in combination with BCG in 100 patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. Among responders, cystectomy avoidance was 84% at 36 months. The median duration of complete response (CR) was 26.6 months, with some responses extending beyond 53 months—emphasizing support for ANKTIVA by a mature dataset.