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) announced two poster presentations and one online publication at the ASCO 2026 Annual Meeting in Chicago.
The work centers on ANKTIVA (nogapendekin alfa inbakicept-pmln), an IL-15 receptor agonist immunotherapy, in randomized Phase 3 non-small cell lung cancer trials and a matched adjusted indirect comparison in BCG-unresponsive non-muscle invasive bladder cancer.
ImmunityBio (NASDAQ: IBRX) reported survey results from 86 UK adults with BCG-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC), presented at ISPOR 2026. The mixed-methods study examined preferences between bladder preservation and radical cystectomy after BCG failure.
Findings show treatment choices vary by prior treatment, age, values, and views on clinical effectiveness, quality of life, and lifestyle disruption, underscoring the need for individualized, patient-centered care and shared decision-making.
ImmunityBio (NASDAQ: IBRX) reported preliminary health economic results showing ANKTIVA plus BCG had lower cost per sustained complete responder and per cystectomy avoided than TAR-200 in BCG-unresponsive NMIBC CIS over three years in a U.S. Medicare model.
The Markov cost-consequence analysis, using QUILT-3.032 and SunRISe-1 data, found savings per cystectomy avoided of $109,622 (Year 1), $151,438 (Year 2), and $60,393 (Year 3, vs TAR-200), and complete response rates of 49.6% for ANKTIVA plus BCG versus 45.9% for TAR-200.
ImmunityBio (NASDAQ: IBRX) announced FDA acceptance of a supplemental BLA for ANKTIVA plus BCG to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease without CIS. The FDA set a PDUFA action date of January 6, 2027.
The sBLA is supported by QUILT 3.032 Cohort B data in 80 patients, including 12‑month disease-free survival of 58.2%, 36‑month progression-free survival of 82.0%, cystectomy-free survival of 83.1%, and disease-specific survival of 96.0%. Safety appeared consistent with ANKTIVA’s existing indication. NMIBC represents about 80% of U.S. bladder cancer cases, and roughly 85% present with papillary disease.
ImmunityBio (NASDAQ: IBRX) reported indirect comparative data at AUA 2026 for nogapendekin alfa inbakicept (NAI, ANKTIVA) plus BCG in BCG-unresponsive NMIBC with CIS.
According to ImmunityBio, NAI+BCG showed higher complete response rates, longer median response duration, reduced cystectomy risk versus nadofaragene, and fewer adverse events versus TAR-200, with important methodological limitations noted.
ImmunityBio (NASDAQ: IBRX) announced five issued U.S. patents covering the combination of ANKTIVA and BCG for cancer treatment, with terms through at least 2035.
The portfolio protects compositions, intravesical dosing regimens, two-vial kits, and methods for treating non-muscle invasive bladder cancer, supporting its ANKTIVA plus BCG franchise and trials.
ImmunityBio (NASDAQ: IBRX) signed an exclusive U.S. development and supply agreement with Japan BCG Laboratory for the Tokyo strain of BCG (Tokyo-172 BCG) for bladder cancer.
The deal, backed by positive Phase III SWOG S1602 data, gives ImmunityBio a second potential BCG source while it plans an FDA Biologics License Application.
ImmunityBio (NASDAQ: IBRX) reported Q1 2026 net product revenue of $44.2 million, up ~168% year-over-year and 15% sequentially. Cash, cash equivalents and marketable securities totaled $380.9 million as of March 31, 2026. The pivotal BCG-naïve NMIBC trial is fully enrolled and an sBLA submission is on track for 2026. NCCN updated guidelines to include ANKTIVA plus BCG for BCG-unresponsive papillary-only disease (Category 2A).
ImmunityBio (NASDAQ: IBRX) will present new comparative analyses of ANKTIVA (nogapendekin alfa inbakicept) + BCG versus nadofaragene firadenovec-vncg and TAR-200 for NMIBC CIS ± papillary disease at AUA 2026, May 15–18 in Washington, DC.
Additional presentations include intravesical recombinant BCG (rBCG) research in BCG‑naïve patients, an update on a randomized BCG‑naïve registrational trial, and company efforts to expand BCG access.
ImmunityBio (NASDAQ: IBRX) announced commercial availability of ANKTIVA in Saudi Arabia for two approved indications: BCG-unresponsive non-muscle invasive bladder cancer (CIS) and metastatic non-small cell lung cancer in combination with checkpoint inhibitors. Distribution is via partnerships with Biopharma and Cigalah Healthcare, with initial patients identified and dosing to begin.
ANKTIVA received SFDA authorization in January 2026; the drug previously obtained FDA approval in April 2024 and several regional approvals in 2025–2026.