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) has announced new data from its QUILT 3.032 study, where 100 patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC CIS) were treated with ANKTIVA in combination with BCG. The treatment achieved a 71% complete response rate, with durable responses extending up to 54 months. The company plans to submit this updated data to the European Medicines Agency (EMA) in Q4 2024 as part of a Marketing Authorization Application. The results align with previous findings published in the New England Journal of Medicine and demonstrate ANKTIVA's potential in treating patients with treatment options.
ImmunityBio (NASDAQ: IBRX) reported Q3 2024 financial results, highlighting $6.0 million in net product revenue from ANKTIVA®, significantly up from $1.0 million in the previous quarter. The company secured coverage for over 200 million medical lives and received a J-code effective January 2025. ANKTIVA's shelf life was extended to three years with 125,000 doses available. The company submitted MAA applications in the UK and plans EU submission in Q4 2024. Financial results showed cash position of $130.4 million, with a net loss of $85.7 million compared to $95.6 million in Q3 2023. R&D expenses increased to $50.4 million, while SG&A expenses rose to $35.9 million.
ImmunityBio (NASDAQ: IBRX) has initiated dosing in its Phase 1 clinical trial of CAR-NK cell therapy for treating relapsed B-cell Non-Hodgkin Lymphoma. The QUILT 106 trial, testing CD19-targeted high-affinity natural killer cells, represents the first NK cell-based therapy study in Africa. The trial will enroll up to 10 participants across three South African cities. Initially testing the therapy as a single agent, the study will later combine it with rituximab after safety confirmation. Full enrollment is expected in Q1 2025, with topline data anticipated in H2 2025. This trial mirrors the company's U.S.-based QUILT 3.092 study.
ImmunityBio (NASDAQ: IBRX), an immunotherapy innovator, has announced its participation in the Jefferies London Healthcare Conference. The event is scheduled for November 19-21, 2024 at the Waldorf Hilton London. Company executives will engage in a fireside chat on Tuesday, November 19, 2024, at 2:30 PM GT.
Investors and interested parties can access a replay of the recorded presentation through the Events and Presentations section of ImmunityBio's website at https://ir.immunitybio.com/. The replay will be available for 90 days following the conference.
ImmunityBio (NASDAQ: IBRX) presented positive long-term overall survival data for non-small cell lung cancer (NSCLC) patients at the World Conference on Lung Cancer. The Phase 2 QUILT 3.055 trial showed extended survival of 14 months to five years for advanced NSCLC patients treated with ANKTIVA in combination with checkpoint inhibitors like KEYTRUDA or OPDIVO. Key findings include:
- 57% overall survival at 12 months
- 34% overall survival at 18 months
- Survival independent of PDL1 tumor status and line of therapy
- Efficacy in patients who progressed on previous checkpoint inhibitor treatments
Based on these results, ImmunityBio plans to launch global Phase 3 randomized control ResQ trials of ANKTIVA plus KEYTRUDA or OPDIVO in 1st and 2nd line NSCLC (ResQ301 and ResQ302) versus standard of care.
ImmunityBio (NASDAQ: IBRX) has made significant progress in market access for ANKTIVA®, its FDA-approved treatment for non-muscle invasive bladder cancer with carcinoma in situ (CIS). Within three months of approval, ANKTIVA® is now covered by over a dozen insurance plans, representing more than 100 million lives. The company is expanding its bladder cancer program globally, initiating the filing process with the European Medicines Agency (EMA) for EU approval and launching a BCG naïve trial (QUILT-2.005) in India.
ImmunityBio has also held an FDA meeting regarding ANKTIVA's potential in Non-Small Cell Lung Cancer (NSCLC) following positive overall survival results in a completed trial. The company is preparing additional study information for a potential NSCLC pivotal trial. These developments mark significant steps in expanding ANKTIVA's reach and potential applications in cancer treatment.
ImmunityBio (NASDAQ: IBRX) has announced a new clinical trial, QUILT 502, to study ANKTIVA® in combination with the AdHER2DC vaccine for endometrial cancer. This Phase 1/2 study, sponsored by the National Cancer Institute, will enroll 60 participants with HER2-positive endometrial cancer. The trial combines ANKTIVA, recently FDA-approved for bladder cancer, with the investigational AdHER2DC vaccine and FDA-approved drugs pembrolizumab and lenvatinib.
The study aims to evaluate the safety and efficacy of this combination therapy in controlling endometrial cancer, which affects over 65,000 women annually in the U.S. and has treatment options after second-line therapy. The AdHER2DC vaccine targets the HER2 protein, elevated in 30% of endometrial cancer cases. The trial is expected to be completed in 2026 and represents a potential breakthrough in immunotherapy for gynecological cancers.
ImmunityBio has announced the initial commercial administration of ANKTIVA®, an FDA-approved immunotherapy for Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC). Approved less than two months ago, ANKTIVA activates natural killer cells and T cells to attack resistant tumor cells, showing a prolonged complete response duration exceeding 47 months. Multiple patients across the U.S. have already received the treatment.
The therapy, covered by various healthcare plans, can be administered by urologists in their own offices. This first-in-class cytokine therapy aims to provide an alternative to bladder removal surgeries. The ImmunityBio CARE™ program supports patients with benefits investigation, prior authorization, and claims processing.
ImmunityBio (NASDAQ: IBRX) has announced its 2024 Annual Meeting of Stockholders, scheduled for June 11, 2024, at 9:30 a.m. PT. The meeting will be held virtually with no physical location. Shareholders of record as of April 17, 2024, are eligible to vote and participate.
Chief Executive Officer Richard Adcock will provide a business update following the formal business proceedings. Non-shareholders can join the virtual meeting as guests. A replay will be available within 24 hours on the company's investor relations website and remain accessible for 90 days.
Additional presentations and webcasts on company developments can also be found on the investor relations site, which may contain material information.
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.