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. (NASDAQ: IBRX) generates frequent news as a commercial-stage biotechnology company centered on IL‑15–based immunotherapies and cell therapies. Its updates often highlight clinical data, regulatory milestones, and commercial performance for ANKTIVA, an IL‑15 receptor agonist fusion complex that the company describes as a key component of its BioShield platform.
News coverage commonly focuses on bladder cancer and non‑small cell lung cancer (NSCLC). For non‑muscle invasive bladder cancer, ImmunityBio reports results from the QUILT‑3.032 trial of ANKTIVA plus BCG in BCG‑unresponsive disease, including data on disease‑specific survival, progression‑free survival, and cystectomy avoidance. For NSCLC, press releases describe findings from QUILT‑2.023 and QUILT‑3.055, where ANKTIVA combined with checkpoint inhibitors has been associated with immune restoration, measured by absolute lymphocyte count, and linked to survival outcomes in checkpoint‑experienced patients.
Regulatory developments are another major news theme. Recent announcements include a conditional marketing authorization recommendation from the European Medicines Agency for ANKTIVA plus BCG in BCG‑unresponsive NMIBC CIS, as well as Saudi Food and Drug Authority approvals for ANKTIVA plus BCG in NMIBC CIS and for ANKTIVA in combination with checkpoint inhibitors in metastatic NSCLC, including the first approval for subcutaneous administration. These items illustrate how ImmunityBio’s news flow tracks the global expansion of ANKTIVA‑based regimens.
Investors and observers can also expect news on financial results and product revenue, particularly net product revenue and unit growth for ANKTIVA, along with cash position and capital‑raising activities disclosed in earnings releases and related Form 8‑K filings. Additional stories cover early data in glioblastoma using ANKTIVA plus NK cell therapy and the Optune Gio device, initiatives in non‑Hodgkin lymphoma and other cancers, and participation in forums such as the U.S.–Saudi Biotech Alliance Summit.
By following ImmunityBio’s news page, readers can track clinical trial progress, new approvals, and commercial trends that shape the outlook for IBRX and its IL‑15–based immunotherapy programs.
ImmunityBio (NASDAQ: IBRX) announced three podcasts with UroToday discussing the FDA approval of ANKTIVA® (N-803) plus BCG for non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS). Dr. Patrick Soon-Shiong and Dr. Ashish Kamat highlighted ANKTIVA’s unique mechanism, which activates NK cells, killer T cells, and memory T cells to fight tumors. They emphasized the collaboration with Serum Institute of India to address BCG shortages. ANKTIVA, an IL-15 receptor agonist, offers a new treatment option for BCG-unresponsive NMIBC patients, promoting durable complete responses by converting MHC-negative tumors to MHC-positive. The podcasts are available on UroToday's website.
ImmunityBio, Inc. (NASDAQ: IBRX) has completed the drug substance manufacturing for ANKTIVA, providing 170,000 doses, with two-year storage stability data. The company's GMP fill-finish facility in New York is on track for completion in 12-18 months, capable of producing a million vials annually. The recent partnership with the Serum Institute of India for BCG availability enhances the company's inventory and capacity.
ImmunityBio, Inc. (NASDAQ: IBRX) has entered into an exclusive global agreement with the Serum Institute of India to supply Bacillus Calmette-Guerin (BCG) for use in combination with ImmunityBio's ANKTIVA.
This collaboration will address the chronic BCG supply shortage issue, providing both standard BCG (sBCG) and next-generation recombinant BCG (iBCG) for approved indications benefiting from ANKTIVA's therapeutic effects.
The agreement aims to enhance immunogenicity and safety compared to standard BCG, improving outcomes for bladder cancer patients globally.
ImmunityBio's Executive Chairman, Dr. Patrick Soon-Shiong, will discuss the recent FDA approval of ANKTIVA® for use in combination with BCG for non-muscle invasive bladder cancer at the AUA 2024 conference. ANKTIVA's Breakthrough Therapy designation and novel mechanism will be highlighted, offering an alternative therapy to radical surgery for advanced bladder cancer cases. The discussion will focus on transforming cold bladder cancer cells to hot tumors via ANKTIVA's activation of NK and T cells, resulting in durable responses.
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