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. (NASDAQ: IBRX) generates frequent news as a commercial-stage biotechnology company centered on IL‑15–based immunotherapies and cell therapies. Its updates often highlight clinical data, regulatory milestones, and commercial performance for ANKTIVA, an IL‑15 receptor agonist fusion complex that the company describes as a key component of its BioShield platform.
News coverage commonly focuses on bladder cancer and non‑small cell lung cancer (NSCLC). For non‑muscle invasive bladder cancer, ImmunityBio reports results from the QUILT‑3.032 trial of ANKTIVA plus BCG in BCG‑unresponsive disease, including data on disease‑specific survival, progression‑free survival, and cystectomy avoidance. For NSCLC, press releases describe findings from QUILT‑2.023 and QUILT‑3.055, where ANKTIVA combined with checkpoint inhibitors has been associated with immune restoration, measured by absolute lymphocyte count, and linked to survival outcomes in checkpoint‑experienced patients.
Regulatory developments are another major news theme. Recent announcements include a conditional marketing authorization recommendation from the European Medicines Agency for ANKTIVA plus BCG in BCG‑unresponsive NMIBC CIS, as well as Saudi Food and Drug Authority approvals for ANKTIVA plus BCG in NMIBC CIS and for ANKTIVA in combination with checkpoint inhibitors in metastatic NSCLC, including the first approval for subcutaneous administration. These items illustrate how ImmunityBio’s news flow tracks the global expansion of ANKTIVA‑based regimens.
Investors and observers can also expect news on financial results and product revenue, particularly net product revenue and unit growth for ANKTIVA, along with cash position and capital‑raising activities disclosed in earnings releases and related Form 8‑K filings. Additional stories cover early data in glioblastoma using ANKTIVA plus NK cell therapy and the Optune Gio device, initiatives in non‑Hodgkin lymphoma and other cancers, and participation in forums such as the U.S.–Saudi Biotech Alliance Summit.
By following ImmunityBio’s news page, readers can track clinical trial progress, new approvals, and commercial trends that shape the outlook for IBRX and its IL‑15–based immunotherapy programs.
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.
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.