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. (symbol: IBRX) is a pioneering biotechnology company specializing in immuno-oncology and infectious disease treatments. With a focus on activating both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems, ImmunityBio is at the forefront of developing innovative molecular and product platforms.
The company's key platforms include the development of antibody-cytokine fusion proteins, DNA, RNA, and recombinant protein vaccines, as well as cell therapies. ImmunityBio is working on several significant product candidates, such as n-803, aldoxorubicin, and a second-generation adenovirus vector. These platforms are designed to activate natural killer (NK) cells, T cells, tumoricidal macrophages, and memory T cells, providing a comprehensive approach to cancer treatment and infectious disease management.
Anktiva, one of ImmunityBio's leading product candidates, is an IL-15 superagonist antibody-cytokine fusion protein, which enhances the body's immune response against cancer cells. The company's pipeline includes treatments targeting bladder, lung, and colorectal cancers, as well as glioblastoma multiforme (GBM).
Headquartered in the United States, ImmunityBio operates across two geographical segments: the United States and Europe, with key revenue generated from European markets. The company is integrated from discovery and development to commercialization, ensuring a seamless transition of its products from the laboratory to the market.
ImmunityBio has achieved several milestones, including the initiation of pivotal clinical trials and strategic partnerships with leading research institutions. These accomplishments underscore the company's commitment to transforming the landscape of immuno-oncology and infectious disease treatment.
Stay informed about ImmunityBio's latest developments, financial performance, and upcoming projects by visiting our news section regularly.
ImmunityBio (NASDAQ: IBRX) has received FDA authorization for an expanded access program (EAP) to provide recombinant BCG (rBCG), addressing the critical shortage of TICE® BCG for bladder cancer treatment in the US. The alternative BCG source, developed by the Serum Institute of India, has shown promising results in European clinical trials, demonstrating potent immunogenicity and improved safety compared to earlier BCG strains.
A recent Sermo survey revealed that 57% of US urologists were unable to treat patients in the last 12 months due to TICE® BCG shortage. The company has thousands of vials ready for immediate shipment, potentially resolving this significant treatment impediment. The rBCG has completed Phase 2 clinical trials in Europe for non-muscle invasive bladder cancer (NMIBC).
ImmunityBio (NASDAQ: IBRX) announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application for ANKTIVA®. The application is for ANKTIVA® in combination with BCG for treating patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
This acceptance follows the European Medicines Agency's recent review acceptance for 30 EU countries and comes 10 months after FDA approval in the United States. The MHRA will now begin assessing the marketing authorization application for potential approval in the UK market.
ImmunityBio (NASDAQ: IBRX) has partnered with BeiGene to conduct a confirmatory Phase 3 trial combining BeiGene's tislelizumab (PD-1 checkpoint inhibitor) with ImmunityBio's ANKTIVA in non-small cell lung cancer (NSCLC). The trial builds on the QUILT 3.055 Phase 2 results, which showed prolonged overall survival in second and third-line NSCLC patients who progressed on checkpoint inhibitor therapies.
The Phase 3 ResQ201A-NSCLC study will include 462 participants and aims to confirm the efficacy demonstrated in QUILT 3.055, where median overall survival reached 14.1 months. ANKTIVA, an IL-15 superagonist, has shown the ability to rescue T cells and restore checkpoint inhibitor efficacy through its unique mechanism of action. ImmunityBio plans to submit a biologics license application (BLA) in 2025 for this indication.
ImmunityBio (NASDAQ: IBRX) announced that the European Medicines Agency (EMA) has accepted its marketing authorization application for ANKTIVA® in combination with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
The application covers 30 European countries and is based on the ongoing QUILT 3.032 study, which demonstrated a 71% complete response rate in 100 patients. The duration of response ranges up to 54 months and is ongoing, surpassing the duration of response of all approved products for this indication. This milestone comes nine months after FDA approval in the United States.
The company has also submitted an application to the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The study results exceed the International Bladder Cancer Group's benchmark of 18 months for meaningful clinical results.
ImmunityBio (NASDAQ: IBRX) has submitted marketing authorization applications for ANKTIVA® plus BCG treatment for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ to both the European Medicines Agency (EMA) and UK's Medicines and Healthcare products Regulatory Agency (MHRA).
The submissions were completed in December 2024 for EMA and November 2024 for MHRA, with assessments expected to be completed by Q4 2025. The EMA application covers 27 EU countries plus Iceland, Norway, and Liechtenstein. Potential approval in both regions could come by 2026.
In the US, ANKTIVA's launch has progressed well, with the treatment now widely accessible through commercial and government insurance programs covering over 240 million lives. The product has received a permanent HCPCS J-code (J9028) from CMS for intravesical use.
ImmunityBio (NASDAQ: IBRX) announces plans for three FDA submissions in 2025: a supplemental BLA for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) in papillary indication, a regulatory submission for an alternative BCG source in partnership with Serum Institute of India, and a BLA for second- and third-line non-small cell lung cancer (NSCLC) treatment.
For NMIBC, clinical data showed a 55% disease-free rate at 12 months and 93% cystectomy avoidance. The QUILT-3.055 Phase 2b study for NSCLC (N=86) demonstrated 14.1 months median overall survival for all patients, extending to 15.8 months in PD-L1 negative subjects, comparing favorably to standard docetaxel treatment's 7-10 months survival rate.
ImmunityBio (NASDAQ: IBRX) announced that its FDA-approved bladder cancer treatment ANKTIVA® has received a permanent J-code (J9028), effective January 1, 2025. The code will streamline billing and reimbursement processes for the drug, which is approved for adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
The company highlighted that ANKTIVA, launched in May 2024, has demonstrated a 71% complete response rate in ongoing QUILT 3.032 study as of November 2024, with response duration up to 54 months. The treatment has secured coverage for over 200 million medical lives through various insurance programs, including VA, DoD, and Medicare.
ImmunityBio (NASDAQ: IBRX) has announced the pricing of its public offering of 33,333,334 shares of common stock at $3.00 per share, expecting to raise approximately $100.0 million in gross proceeds. The company has granted underwriters a 30-day option to purchase up to an additional 5,000,000 shares.
The offering is expected to close around December 12, 2024. The proceeds will be used to advance the commercialization of ANKTIVA® for BCG-unresponsive NMIBC treatment, fund trials in BCG-naïve NMIBC and NSCLC, support research and development, working capital needs, and general corporate purposes. Jefferies and Piper Sandler are serving as joint book-running managers.
ImmunityBio (NASDAQ: IBRX) has announced plans for an underwritten public offering of its common stock. The company will grant underwriters a 30-day option to purchase up to an additional 15% of offered shares. Proceeds will fund ANKTIVA® commercialization for BCG-unresponsive non-muscle invasive bladder cancer treatment, trials in BCG-naïve NMIBC and non-small cell lung cancer, R&D activities, working capital needs, and general corporate purposes. Jefferies and Piper Sandler are acting as joint book-running managers, while BTIG and H.C. Wainwright & Co. serve as co-lead managers.
ImmunityBio (NASDAQ: IBRX) and nCartes have entered a collaboration agreement to automate and streamline clinical trial data fulfillment processes. The partnership aims to replace manual data entry into Electronic Data Capture (EDC) systems with direct digital information transfer from electronic medical record (EMR) systems. This automation initiative is designed to make the process faster, more cost-effective, and reduce potential errors in data entry. The collaboration seeks to improve data quality and reduce the time required for source data verification, potentially accelerating the timeline for bringing therapies to market.
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