Welcome to our dedicated page for Immunitybio news (Ticker: IBRX), a resource for investors and traders seeking the latest updates and insights on Immunitybio stock.
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 $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.
ImmunityBio (NASDAQ: IBRX) launched ResQ215B, a Phase 2, chemotherapy-free and lymphodepletion-free outpatient study testing off-the-shelf CD19 t-haNK CAR-NK cells combined with ANKTIVA® (nogapendekin-alfa inbakicept) and rituximab in indolent B-cell non-Hodgkin lymphoma, including Waldenström’s Macroglobulinemia.
The trial builds on Phase 1 QUILT-106 results that reported durable complete responses and a small chemotherapy-free cohort in which all four Waldenström’s patients achieved disease control without hospitalization.
ImmunityBio (NASDAQ: IBRX) reported updated Phase 2 QUILT-3.078 data in recurrent or progressive glioblastoma as of January 22, 2026. Of 23 enrolled patients, 19 remain alive and median overall survival is not yet reached; four deaths reported. In the 14-patient evaluable cohort (median follow-up 6 months), the longest survival from recurrence reached 12 months and ongoing. Baseline mean absolute lymphocyte count (ALC) was ~0.9 x10^3/µL; mean ALC rose to ≥ 1.4 x10^3/µL within one cycle (p<0.001, N=14) and remained significantly increased through 20 weeks (p≤0.026). The regimen showed a manageable safety profile: 3 treatment-related serious adverse events reported and no CRS or ICANS. Randomized 1L and 2L+ trials are in development.
ImmunityBio (NASDAQ: IBRX) held a Type B End-of-Phase meeting with the U.S. FDA about a supplemental BLA for ANKTIVA in BCG-unresponsive papillary NMIBC. The FDA recommended submission of additional information to support a potential resubmission of the sBLA; ImmunityBio compiled the requested materials and will submit them within 30 days. Long-term data in papillary patients (N=80) show ~96% bladder cancer-specific survival at 36 months, >80% bladder preservation at three years, and median survival not yet reached. ANKTIVA is commercially launched for NMIBC CIS in the U.S. and has approvals in the UK and Saudi Arabia and conditional approval in the EU.
ImmunityBio (NASDAQ: IBRX) reported updated QUILT-106 results showing durable complete responses with an off-the-shelf CD19 CAR-NK plus rituximab in Waldenström Non-Hodgkin lymphoma.
Four enrolled patients achieved 100% disease control to date; two evaluable patients have ongoing complete responses at 7 months and 15 months after completing eight outpatient doses (four cycles) with no lymphodepletion or further therapy.
ImmunityBio (NASDAQ: IBRX) reported that enrollment in its randomized registrational trial QUILT-2.005 for BCG‑naïve non‑muscle‑invasive bladder cancer (NMIBC) has exceeded expectations and is over 85% complete, with full enrollment anticipated by Q2 2026. Based on the current trajectory, the company anticipates submitting a BLA to FDA by year‑end 2026. An FDA‑requested interim analysis showed that ANKTIVA + BCG significantly prolonged duration of complete response versus BCG alone: 6‑month CR 85% vs 57%, 9‑month CR 84% vs 52%, with the 9‑month difference reaching statistical significance (p=0.0455). The company noted an Expanded Access Program for recombinant BCG is proceeding and has requested FDA consultation on recombinant BCG as an alternative supply.