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.
PDS Biotechnology (PDSB) closed an initial tranche of a PIPE financing on September 14, 2026, raising gross proceeds of approximately $11.3 million led by Nant Capital, with Dr. Patrick Soon-Shiong joining its board.
At the Initial Closing, the company issued 16,502,870 common shares, 23,498,156 pre-funded warrants and 20,000,514 common warrants, at unit prices of $0.2825 per share-and-warrant unit and $0.28217 per pre-funded-and-warrant unit. A contingent Milestone Closing would add $10 million from Nant and $1 million from AB Group Ltd., triggered by submission to the FDA of a registrational Phase 3 protocol for PDS0301 designed with Nant, subject to closing conditions and a 19.9% beneficial ownership cap per investor.
The funds are intended for debt repayment, working capital and clinical development, including advancing PDS0301, which in an NCI-led Phase 2 trial in 22 MSS/pMMR mCRC patients showed good tolerability and 80% 24‑month survival. NantWorks also received a one‑year exclusive right to negotiate an exclusive license to HPV‑targeted immunotherapy PDS0101, and James Banaag of NantBio also joined the PDS board.
ImmunityBio (NASDAQ: IBRX) appointed Dr. Jim Yong Kim as Vice Chairman, effective with the creation of a new Office of the Executive Chairman. Reporting to Founder and Executive Chairman Dr. Patrick Soon-Shiong, Dr. Kim will focus on international strategy, partnerships, and global access to ImmunityBio’s immunotherapy platform and approved therapies outside the U.S.
According to the company, the Office of the Executive Chairman will coordinate senior leaders on global strategy and clinical initiatives. Dr. Kim brings prior leadership experience from the World Bank, Partners In Health, WHO’s HIV/AIDS department, Dartmouth College, and major academic institutions.
ImmunityBio (NASDAQ: IBRX) reported record Q2 2026 net product revenue of $50.7 million, up 92% year-over-year and 15% sequentially, marking the eighth consecutive quarter of sequential growth for ANKTIVA. First-half 2026 net product revenue reached $94.8 million, up 121% versus the first half of 2025. Total Q2 revenue was $51.2 million.
Despite revenue growth, Q2 net loss attributable to common stockholders widened to $230.4 million, and first-half net loss to $863.2 million, mainly from non-cash fair value changes and higher interest expense, R&D, and SG&A. Adjusted net loss improved to $81.0 million in Q2 and $167.3 million for the first half. As of June 30, 2026, cash, cash equivalents, and marketable securities totaled $357.4 million. The company highlighted FDA acceptance of an ANKTIVA sBLA with a January 6, 2027 PDUFA date, new UAE marketing authorization, and a U.S.-exclusive Tokyo-172 BCG supply agreement.
ImmunityBio (NASDAQ: IBRX) announced that the Emirates Drug Establishment has granted UAE Marketing Authorization for ANKTIVA across two indications: BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC) and metastatic non‑small cell lung cancer (NSCLC). The UAE becomes the fifth jurisdiction to authorize ANKTIVA, expanding its regulatory footprint to 34 countries.
The NMIBC label is the first worldwide to cover the full spectrum of BCG‑unresponsive disease, including CIS with or without papillary tumors and papillary‑only disease, using ANKTIVA 0.4 mg with BCG. In QUILT‑3.032, CIS patients (N=100) achieved a 71% complete response rate and median response duration of 26.6 months; papillary‑only patients (N=80) showed 12‑month disease‑free survival of 58.2% and a 36‑month cystectomy‑free rate of 83.1%.
For metastatic NSCLC that has progressed after checkpoint inhibitors (and chemotherapy where applicable), the UAE authorized ANKTIVA 1.2 mg with checkpoint inhibitors. Phase 2 QUILT‑3.055 reported median overall survival of 14.6 months (16.2 months in patients with mean on‑treatment ALC ≥1,000). According to ImmunityBio, UAE registrations for both presentations are valid from July 2026 through July 2031, with Modern Pharmaceutical Company as local agent.
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 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) 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) 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.