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 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.
ImmunityBio (NASDAQ: IBRX) reported preliminary Q1 2026 net product revenue of approximately $44.2 million, up ~168% year-over-year and +15% sequentially, and ended the quarter with about $380.9 million in cash, cash equivalents and marketable securities.
ANKTIVA unit sales rose 168% YoY; approvals or authorizations now cover ~34 countries; pivotal trial QUILT-2.005 fully enrolled with IDMC confirmation; supplemental BLA on track for 2026.
ImmunityBio (NASDAQ: IBRX) submitted a comprehensive response to FDA OPDP on April 6, 2026, addressing concerns about a podcast and a referenced television advertisement for ANKTIVA.
The company removed the podcast from its site, requested third‑party removal, confirmed the TV ad was never broadcast, and outlined enhanced promotional review, executive training, and external regulatory oversight.
ImmunityBio (NASDAQ: IBRX) secured $75 million of additional non-dilutive financing under its existing RIPA with Oberland Capital, raising total committed capital under the agreement to $375 million. Simultaneously, $25 million of promissory note principal was converted into 4.6 million common shares, reducing debt under the $505 million December 2024 promissory note.
Proceeds are intended to strengthen the balance sheet, support global expansion after recent ANKTIVA approvals and advance the company’s broader immunotherapy pipeline. ANKTIVA is now approved or authorized across approximately 34 countries following regulatory decisions from the FDA, EC, MHRA, SFDA and others.
ImmunityBio (NASDAQ: IBRX) reported that the randomized QUILT-2.005 trial (N=366) is fully enrolled and the Independent Data Monitoring Committee confirmed the study is adequately powered to detect the pre‑specified difference in complete response (CR) rate between ANKTIVA + BCG and BCG alone.
The IDMC found no additional enrollment is required and ImmunityBio remains on track for a supplemental Biologics License Application submission in 2026.
ImmunityBio (NASDAQ: IBRX) announced regulatory approval in Macau SAR, China for ANKTIVA (nogapendekin alfa inbakicept-pmln) to treat adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) ± papillary tumors.
The authorization used a reliance-based review referencing prior FDA and EMA decisions, marks ANKTIVA’s first approval in Asia, and supports the company’s ongoing global expansion across 34 countries and territories. The company cited QUILT 3.032 data published in NEJM Evidence and The Journal of Urology demonstrating durable responses.
ImmunityBio (NASDAQ: IBRX) announced the 2026 NCCN Bladder Cancer guidelines (Version 1.2026) now include ANKTIVA plus BCG for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary-only disease.
Both papillary-only and CIS indications are listed as Category 2A. The update references peer-reviewed clinical data from QUILT-3.032 and notes this use is not currently in the FDA label.
ImmunityBio (NASDAQ: IBRX) reported successful validation of large‑scale manufacturing and cryo‑banking for autologous memory cytokine‑enhanced NK (M‑ceNK) cells.
Key metrics: single apheresis yields up to 5×10⁹ NK cells, providing 8–10 doses; finished doses available within 12 days; programs enrolled 74 subjects with manufacturing datasets from 64 apheresis collections. Phase 1 (QUILT‑3.076) combined M‑ceNK with ANKTIVA® in 10 patients with no Grade 4/5 TRAEs reported. Cryopreserved M‑ceNK retained tumor cytotoxicity across multiple histologies.