ImmunityBio, Inc. reports developments as a commercial-stage biotechnology company focused on immunotherapies designed to activate innate and adaptive immune responses for cancer and infectious disease. Its news centers on ANKTIVA® (nogapendekin alfa inbakicept-pmln), an IL-15 superagonist used with BCG for BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, with or without papillary tumors.
Recurring updates cover ANKTIVA product revenue and unit demand, global regulatory authorizations and commercial availability, distribution partnerships, and scientific presentations involving bladder cancer, lung cancer, and broader IL-15 oncology programs. Company announcements also address BCG-naïve NMIBC clinical development, FDA promotional-compliance correspondence, and financing arrangements tied to revenue interests and convertible debt.
ImmunityBio (NASDAQ: IBRX) reported successful validation of large‑scale manufacturing and cryo‑banking for autologous memory cytokine‑enhanced NK (M‑ceNK) cells.
Key metrics: single apheresis yields up to 5×10⁹ NK cells, providing 8–10 doses; finished doses available within 12 days; programs enrolled 74 subjects with manufacturing datasets from 64 apheresis collections. Phase 1 (QUILT‑3.076) combined M‑ceNK with ANKTIVA® in 10 patients with no Grade 4/5 TRAEs reported. Cryopreserved M‑ceNK retained tumor cytotoxicity across multiple histologies.
ImmunityBio (NASDAQ: IBRX) resubmitted a supplemental BLA to the FDA on March 9, 2026 for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary-only tumors. The FDA acknowledged receipt after requesting additional efficacy and long-term follow-up data; no new trials were requested. The company cites published long-term safety and bladder-preservation data and also notes a separate SFDA approval for ANKTIVA combinations in metastatic NSCLC.
ImmunityBio (NASDAQ: IBRX) will host a live conference call at 1:30 p.m. PT / 4:30 p.m. ET on Tuesday, March 3, 2026 to provide a business update and review financial results for the year ended December 31, 2025.
According to the company, the call will cover progress across its clinical trial pipeline. Interested parties can join via the investor relations website or by phone; a replay will be posted and available for at least 90 days.
ImmunityBio (NASDAQ: IBRX) completed enrollment in the randomized QUILT 2.005 trial with 366 BCG-naïve NMIBC CIS patients, randomized to ANKTIVA plus BCG or BCG alone. An FDA-requested interim analysis showed improved duration of complete response for ANKTIVA plus BCG (9-month CR 84% vs 52%, p=0.0455) with no new safety signals. The company plans to submit a BLA by Q4 2026 and continues a recombinant BCG Expanded Access Program with 580 patients enrolled.
ImmunityBio (Nasdaq: IBRX) announced that Founder and Executive Chairman Dr. Patrick Soon-Shiong will speak at the "Cancer 2035: A Roadmap for the Future" summit in Washington, D.C., held February 23–24, 2026.
The two-day summit, co-hosted by the Milken Institute and the Richard Nixon Foundation, convenes leading oncology, immunology, and policy figures to discuss reducing cancer mortality by 2035; sessions will be streamed live.
ImmunityBio (NASDAQ: IBRX) reported $113 million in full-year 2025 net product revenue for ANKTIVA, an approximately 700% YoY increase, driven by a 750% unit sales rise and Q4 net product revenue of $38.3M. ANKTIVA gained authorization across 33 countries in four jurisdictions and received the first global conditional SFDA approval for metastatic NSCLC in January 2026, with a commercial launch planned within 60 days. The company reported $242.8M in cash and marketable securities and highlighted global partnerships and patent protection through 2035 and beyond.
ImmunityBio (NASDAQ: IBRX) announced a commercial partnership with Biopharma and Cigalah to launch ANKTIVA in Saudi Arabia and expand across MENA. The company established a wholly owned Saudi subsidiary, secured Saudi FDA registration with pricing, and expects distribution within 60 days. SFDA also approved ANKTIVA with a checkpoint inhibitor for metastatic non-small cell lung cancer.
The drug has prior approvals from the FDA (April 2024), MHRA (July 2025), and European Commission (Feb 2026).
ImmunityBio (NASDAQ: IBRX) announced a European distribution partnership with Accord Healthcare and opened an Irish subsidiary in Dublin to support commercialization of ANKTIVA for BCG-unresponsive NMIBC CIS.
The partnership deploys an 85-person salesforce across 30 countries; ANKTIVA has authorization across 33 countries, including an EU conditional marketing authorization in February 2026.
ImmunityBio (NASDAQ: IBRX) received European Commission conditional marketing authorization for ANKTIVA® plus BCG to treat adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors.
Key metrics: 71% complete response rate, median duration of complete response 26.6 months, responses up to 54+ months. Authorization expands ANKTIVA to 33 countries across four jurisdictions and requires ongoing follow-up and long-term data submission.
ImmunityBio (NYSE: IBRX) reported productive regulatory engagement with the Saudi Food and Drug Authority (SFDA) on February 17, 2026. Key outcomes: SFDA encouraged submission of a recombinant BCG (rBCG) regulatory package to address global BCG shortages, and initiated discussions to expand ANKTIVA plus checkpoint inhibitor indications beyond NSCLC.
SFDA has approved ANKTIVA in Saudi Arabia for BCG-unresponsive non-muscle invasive bladder cancer and metastatic NSCLC; ImmunityBio expects to submit the rBCG dossier within weeks and cites QUILT-3.055 Phase 2b data showing 14.1-month median OS in CPI-relapsed NSCLC.