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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 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.
ImmunityBio (NASDAQ: IBRX) reported strong commercial momentum for ANKTIVA with preliminary full-year net product revenue of ~$113.0M, a ~700% year‑over‑year increase. For the quarter ended Dec 31, 2025, preliminary net product revenue was ~$38.3M, up 20% sequentially from $31.8M and up 431% year‑over‑year. ANKTIVA unit sales grew ~750% in 2025 versus 2024. The company held an estimated $242.8M in cash, cash equivalents and marketable securities at Dec 31, 2025. Regulatory progress includes SFDA approvals for ANKTIVA plus checkpoint inhibitors in metastatic NSCLC (first global approval for this indication and first subcutaneous authorization) and for ANKTIVA plus BCG in BCG‑unresponsive NMIBC CIS. Phase 2b QUILT‑2.005 enrollment is ahead of expectations with full enrollment expected in H1 2026.
ImmunityBio (NASDAQ: IBRX) said the Saudi Food and Drug Authority granted accelerated approval for ANKTIVA® (nogapendekin alfa inbakicept) plus BCG to treat adult patients with BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary disease, based on QUILT‑3.032 data.
This approval joins existing U.S. and U.K. approvals and a conditional EU approval. ImmunityBio plans a regional office in Saudi Arabia and named Biopharma Cigalah as its commercial partner for the Middle East and North Africa. The randomized QUILT‑2.005 trial in BCG‑naïve NMIBC is ahead of schedule, with full enrollment expected by Q2 2026 and a potential BLA submission targeted by year‑end 2026.
ImmunityBio (NASDAQ: IBRX) announced that the Saudi Food and Drug Authority granted accelerated approval to ANKTIVA (nogapendekin alfa inbakicept) in combination with immune checkpoint inhibitors for adult patients with metastatic non-small cell lung cancer whose disease progressed after standard‑of‑care therapy.
This is the company's first global approval and the first subcutaneous IL‑15 receptor superagonist approval. Approval was based on QUILT‑3.055 and QUILT‑2.023 data showing lymphocyte recovery (ALC) associated with improved survival; a confirmatory randomized trial (ResQ 201A) is ongoing. ImmunityBio plans a Saudi regional office and a commercial partnership with Biopharma Cigalah.
ImmunityBio (NASDAQ: IBRX) reported positive clinical results showing ANKTIVA® (nogapendekin alfa inbakicept) acts as a lymphocyte-stimulating agent when combined with checkpoint inhibitors in non-small cell lung cancer (NSCLC).
Across 151 patients in two trials (QUILT-2.023 first-line; QUILT-3.055 second-/later-line), ANKTIVA plus CPI produced a statistically significant ALC rise versus CPI alone (p=0.0065) and restored/maintained ALC ≥1.0×10³/µL in 77% of patients. Responders had longer median overall survival (16.2 vs 11.8 months; HR 0.52; p=0.0369); patients with ALC ≥1.2×10³/µL had median OS 21.1 months (HR 0.33; p=0.0009), independent of PD-L1. A Phase 3 randomized confirmatory trial (ResQ201A) versus docetaxel is ongoing.
ImmunityBio (NASDAQ: IBRX) and NantWorks announced the inaugural U.S.-Saudi Biotech Alliance Summit on Jan 14, 2026 in San Francisco, held alongside the 44th Annual J.P. Morgan Healthcare Conference from 9:00 am to 5:30 pm PT.
Co-chaired by Her Royal Highness Dr. Haya bint Khaled Al Saud, His Excellency Dr. Bandar Alknawy, and Dr. Patrick Soon-Shiong, the Summit convenes U.S. and Saudi leaders across government, biotech, AI, manufacturing, healthcare delivery, and finance to advance implementation-focused collaboration on immunotherapy 2.0, AI-enabled biomanufacturing, pandemic and health-security preparedness, regulatory alignment, and commercialization pathways.
ImmunityBio (NASDAQ: IBRX) announced that its Founder, Executive Chairman and Global Chief Scientific and Medical Officer Dr. Patrick Soon-Shiong was named one of "The 100 Most Influential People in Oncology in 2025" by OncoDaily on December 29, 2025.
OncoDaily highlighted Soon-Shiong's scientific and research accomplishments and described the list as recognizing changemakers who shape oncology practice across research, patient outcomes, advocacy, philanthropy, leadership, and education. The company noted the recognition underscores Soon-Shiong's leadership and his role in advancing ImmunityBio's mission to develop transformative therapies for people living with cancer and serious diseases.