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, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, will present at the Jefferies London Healthcare Conference in London from November 15-17, 2022. The presentation is scheduled for November 15 from 4:25–4:55 PM BST and will include a corporate presentation followed by a Q&A session. A webcast link for the presentation is available online, and a replay will be archived for 90 days. ImmunityBio is focused on developing therapies and vaccines to enhance the immune system against cancers and infectious diseases, with a clinical pipeline of 27 trials.
Faraday Future has appointed Yun Han as Chief Accounting Officer and Interim Chief Financial Officer, effective October 25, 2022. Han replaces Becky Roof, who served in the interim role until October 12, 2022. The company expects to receive $10 million this week as part of a $60 million financing agreement, following the successful acquisition of $55 million in financing. The funds will support Faraday Future’s operations and its efforts to bring the FF 91 to market. CEO Dr. Carsten Breitfeld expressed confidence in Han’s experience and the company’s growth potential.
The FDA has accepted ImmunityBio's Biologics License Application (BLA) for N-803, an IL-15 superagonist, targeting BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC). This marks a significant milestone for ImmunityBio as it is their first BLA submission. The application is supported by positive results from the QUILT 3.032 trial, where 71% of patients exhibited a complete response, with a median response duration of 26.6 months. The target action date for FDA review is May 23, 2023.
ImmunityBio has released positive data from pivotal clinical trials for treatments in bladder cancer and advanced pancreatic cancer, presented at the ASCO Annual Meeting. In bladder cancer, 71% of patients achieved a complete response, with a median duration of 26.6 months, and a 91% rate of avoiding cystectomy. In pancreatic cancer, the Nant Vaccine doubled median overall survival to 6.2 months. The company is advancing combination immunotherapy strategies and aims to launch additional trials in earlier treatment settings.
ImmunityBio, Inc. has submitted a Biologics License Application (BLA) to the FDA for N-803, a first-in-class IL-15 superagonist, combined with Bacillus Calmette-Guérin (BCG) for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The pivotal QUILT 3032 study showed a 71% response rate in previously untreated patients, outperforming existing therapies. If approved, this would introduce the first new immunotherapy for this condition in 23 years, potentially reducing the need for radical cystectomy.
ImmunityBio, Inc. (NASDAQ: IBRX) announced that data from its QUILT 3.032 trial for BCG-unresponsive non-muscle invasive bladder cancer will be presented at the ASCO Annual Meeting, taking place from June 3-7 in Chicago. Principal Investigator Karim Chamie, M.D., will share final clinical results of the pivotal trial involving the IL-15RαFc superagonist N-803 combined with BCG. Additionally, the QUILT 88 trial results showcasing improved survival rates in advanced pancreatic cancer patients will also be presented. ImmunityBio will exhibit at booth 26135.
ImmunityBio (NASDAQ: IBRX) has enrolled the first participants in a significant clinical trial studying its IL-15 superagonist, Anktiva, combined with Keytruda for patients with non-small cell lung cancer (NSCLC) who have not responded to prior checkpoint inhibitors. This trial, part of the Lung Cancer Master Protocol, aims to enroll 478 patients across nearly 200 U.S. sites. With lung cancer being the second most common cancer in the U.S., the results could significantly impact treatment options and patient outcomes, offering a chemotherapy-free alternative.
ImmunityBio (NASDAQ: IBRX) announced significant progress in its QUILT-3.032 clinical trial for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Over 80 subjects completed at least 12 months of follow-up, with results indicating a 71% complete response rate and a median duration of response of 26.6 months. The company plans to submit its Biologics License Application (BLA) to the FDA this month, following the achievement of Fast Track and Breakthrough Therapy Designations. This positions ImmunityBio as a promising alternative for NMIBC patients.
ImmunityBio, Inc. (NASDAQ: IBRX) announced promising results from a Phase 2 study on cytokine-enriched natural killer (NK) cells for treating acute myeloid leukemia (AML). The study showed that using memory-like NK cells alongside ImmunityBio's IL-15 superagonist, Anktiva™, led to a complete response in 87% of patients after Day 28. The scalable process generates over 20 billion NK cells from a single blood extraction, indicating potential for multiple infusions. These findings support ongoing exploration of m-ceNK cells for liquid and solid tumors.
ImmunityBio, Inc. (NASDAQ: IBRX) has completed its acquisition of a leasehold interest in a pharmaceutical manufacturing facility from Athenex, Inc. (NASDAQ: ATNX) in Dunkirk, New York. This 409,000 square foot facility enhances ImmunityBio's capabilities for large-scale vaccine and immunotherapy production. The site includes clean rooms for manufacturing activities and is expected to significantly expand ImmunityBio's production capacity while reducing capital costs. This strategic move aligns with ImmunityBio's growth plans and aims to accelerate product development.