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 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.
ImmunityBio (NASDAQ: IBRX) reported QUILT-3.032 cohort B (N=80) results showing long-term benefit for ANKTIVA plus BCG in BCG-unresponsive high-grade papillary-only NMIBC.
Key outcomes at 36 months: disease-specific survival (DSS) 96.0%, progression-free survival (PFS) 83.1%, and cystectomy avoidance 81.8%. The 12-month primary endpoint DFS was 58.2% (36-month DFS 38.2%). Safety across cohorts A+B (N=180) was consistent with BCG: 61% grade 1–2 TRAEs, 3% grade 3, no grade 4–5.
ImmunityBio (NASDAQ: IBRX) announced the European Medicines Agency recommended a conditional marketing authorization for ANKTIVA (nogapendekin alfa inbakicept) with BCG to treat adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS).
The EMA opinion cites a single-arm trial of 100 patients showing a 71% complete response rate, responses up to 54+ months, and average response duration of about 27 months (12-month CR 66%; 24-month CR 42%). The EMA recommendation is conditional and will be sent to the European Commission for final EU approval; ImmunityBio must provide long-term post-marketing safety and efficacy data.
ImmunityBio (NASDAQ: IBRX) released a U.S. survey (Nov 13, 2025) showing patients with non-muscle invasive bladder cancer (NMIBC) want more treatment discussions and prefer alternatives to chemotherapy.
Key findings: 18% say HCPs discuss all options most visits; 84% believe immunotherapy has fewer side effects; 72% of immunotherapy recipients are satisfied with duration of positive effects; 81% are open to new treatments; 90% would accept more frequent dosing for longer benefit.
ImmunityBio (NASDAQ: IBRX) reported strong commercial and clinical momentum for ANKTIVA on November 5, 2025.
Key metrics: Q3 2025 product revenue $31.8M (up 434% vs Q3 2024), YTD product sales $74.7M, and 467% year-to-date unit growth versus fiscal 2024. Cash and marketable securities were $257.8M as of Sept 30, 2025. Q3 net loss attributable to common stockholders was $67.3M (vs $85.7M prior year quarter); nine-month net loss was $289.5M (vs $354.4M prior year).
Clinical and program updates: 5-patient glioblastoma cohort showed 100% disease control with ANKTIVA plus Optune Gio and CAR-NK; company is initiating a randomized registration trial in second-line GBM. Enrollment began in a global randomized Phase 3 NSCLC (ResQ201A) trial. QUILT.106 and QUILT-3.032 trials reported early positive signals in lymphoma and NMIBC respectively. ANKTIVA was selected as a preferred drug by a contracting organization covering ~80 million lives.