ImmunityBio, Inc. - Common Stock (IBRX)

ImmunityBio, Inc. (NASDAQIBRX) today announced it has entered into a collaboration and supply agreement with BeiGene, Ltd. (to be changed to BeOne Medicines, Ltd.), a global oncology company, to conduct a confirmatory randomized Phase 3 clinical trial (ResQ201A-NSCLC), combining BeiGene's tislelizumab, a PD-1 checkpoint inhibitor (CPI), and ImmunityBio's ANKTIVA (nogapendekin alfa inbakicept-pmln). The Phase 3 ResQ201A-NSCLC study (NCT06745908) aims to confirm the efficacy and safety of combination ANKTIVA plus CPI therapy previously demonstrated in the trial QUILT 3.055 and provide evidence of the potential for these two immunotherapeutic agents to improve overall survival in patients with advanced or metastatic NSCLC who have acquired resistance to immune CPI therapy.

ImmunityBio, Inc. (NASDAQIBRX), a leading immunotherapy company, today announced the European Medicines Agency (EMA) has accepted for review and begun assessing the marketing authorization application (MAA) for ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. The EMA covers 27 countries in the European Union (EU), as well as Iceland, Norway and Liechtenstein.

ImmunityBio, Inc. (NASDAQIBRX), a leading immunotherapy company, today announced significant progress in its ongoing discussions with the U.S. Food and Drug Administration (FDA) regarding three areas of its clinical development pipeline in non-muscle invasive bladder cancer (NMIBC) and non-small cell lung cancer (NSCLC).

ImmunityBio, Inc. (NASDAQIBRX) today announced the completion of the submissions of its marketing authorization applications (MAA) for ANKTIVA® (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, to both the European Union (EU) European Medicines Agency (EMA) and the United Kingdom's (UK) Medicines and Healthcare products Regulatory Agency (MHRA).

ImmunityBio, Inc. (NASDAQIBRX), a leading immunotherapy company, today announced the unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code assigned by the Centers for Medicare & Medicaid Services (CMS) for ANKTIVA® (nogapendekin alfa inbakicept-pmln) became effective January 1, 2025. The U.S. Food and Drug Administration (FDA) approved ANKTIVA with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

CULVER CITY, Calif., Dec. 12, 2024 (GLOBE NEWSWIRE) -- ImmunityBio, Inc. (NASDAQIBRX), a leading immunotherapy company, today announced the pricing of its previously announced underwritten public offering of an aggregate of 33,333,334 shares of its common stock at a price to the public of $3.00 per share. ImmunityBio has granted the underwriters a 30-day option to purchase up to an additional 5,000,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares were sold by ImmunityBio. Before deducting the underwriting discount and offering expenses payable by ImmunityBio, ImmunityBio expects to receive gross proceeds of approximately $100.0 million, assuming no exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on or about December 12, 2024 subject to satisfaction of customary closing conditions.

ImmunityBio, Inc. (NASDAQIBRX), a leading immunotherapy company, today announced the pricing of its previously announced underwritten public offering of an aggregate of 33,333,334 shares of its common stock at a price to the public of $3.00 per share. ImmunityBio has granted the underwriters a 30-day option to purchase up to an additional 5,000,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares were sold by ImmunityBio. Before deducting the underwriting discount and offering expenses payable by ImmunityBio, ImmunityBio expects to receive gross proceeds of approximately $100.0 million, assuming no exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on or about December 12, 2024 subject to satisfaction of customary closing conditions.

ImmunityBio, Inc. (NASDAQIBRX), a leading immunotherapy company, today announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. In addition, ImmunityBio expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the offering at the public offering price, less underwriting discounts and commissions. ImmunityBio currently intends to use the net proceeds from this offering to progress its continued commercialization of ANKTIVA® for treatment of BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”) with carcinoma in situ (“CIS”) with or without papillary tumors, to fund its trials in BCG-naïve NMIBC and non-small cell lung cancer (“NSCLC”), toward further research and development, for working capital needs, and for other general corporate purposes. All of the shares are being offered by ImmunityBio. There can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

ImmunityBio, Inc. (NASDAQIBRX), a leading immunotherapy company, today announced compelling new data from its ongoing QUILT 3.032 study. As of November 2024, 100 patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (NMIBC CIS) have been treated with ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with BCG, achieving a 71% complete response (CR) rate. In these responders, the range of durable response extended to 54 months. This data update will be submitted to the European Medicines Agency (EMA) in a Marketing Authorization Application (MAA) for ANKTIVA in the European Union (EU), which is anticipated during Q4 2024.

ImmunityBio, Inc. (NASDAQIBRX) today announced its financial results for the third-quarter ended September 30, 2024.

NEW YORK, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against ImmunityBio, Inc. (NASDAQIBRX) on behalf of long-term stockholders following a class action complaint that was filed against ImmunityBio on June 30, 2023 with a Class Period from May 23, 2022 to May 10, 2023. Our investigation concerns whether the board of directors of ImmunityBio have breached their fiduciary duties to the company.

Immunotherapy innovator ImmunityBio, Inc. (NASDAQIBRX), announced today that the first patients have been dosed in an initial trial studying the potential of the company’s CAR-NK cell therapy targeting CD-19 in the treatment of non-Hodgkin’s lymphoma (NHL). In the QUILT 106 trial, CD19-targeted high-affinity natural killer (t-haNK) cells are being tested initially as a single agent, and after demonstrating safety, then in combination with standard NHL treatment rituximab, in participants with selected CD19+ and CD20+ relapsed/refractory B-cell NHL. The phase 1, open label clinical study is designed to enroll up to 10 participants and is being conducted in Johannesburg, Pretoria, and Bloemfontein, South Africa.

Immunotherapy innovator ImmunityBio, Inc. (NASDAQIBRX), announced today that company executives will be participating in the Jefferies London Healthcare Conference, which is taking place November 19-21 at the Waldorf Hilton London.

Immunotherapy innovator ImmunityBio, Inc. (NASDAQIBRX), today announced positive results from its QUILT 3.055 trial demonstrating long-term extended survival of 14 months to as much as five years for patients with advanced non-small cell lung cancer (NSCLC) being treated with checkpoint inhibitors (CPI). An oral presentation of the data was presented by John Wrangle, M.D., MPH, Associate Professor, Medical University of South Carolina, at the World Congress on Lung Cancer in San Diego on Sunday, September 8 in the session titled “Novel Immunotherapy Strategies and Combinations.”

ImmunityBio, Inc. (NASDAQIBRX), today announced significant progress in market access, making ANKTIVA® (nogapendekin alfa inbakicept-pmln) widely available to patients through both commercial and government insurance programs. The company also announced plans to expand its bladder cancer program globally, notably in the European Union and India.

Immunotherapy company ImmunityBio, Inc. (NASDAQIBRX), today announced the opening of a clinical trial to study ANKTIVA® (nogapendekin alfa inbakicept-pmln) together with the investigational AdHER2DC vaccine (autologous dendritic cells transduced with HER2 expressing adenovirus), in individuals with HER2-expressing endometrial cancer. It marks the latest trial involving ANKTIVA, the company’s IL-15 superagonist immune enhancer, to evaluate ANKTIVA as an agent to replace the short-term activity of checkpoint inhibitor immunotherapies with long-term effectiveness. ANKTIVA was recently approved by the FDA for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors.

Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF has commenced an investigation into ImmunityBio, Inc. (NasdaqGS: IBRX).

ImmunityBio, Inc. (NASDAQIBRX) today announced the initial treatment of multiple patients in the United States to receive therapy with ANKTIVA® (nogapendekin alfa inbakicept-pmln), ImmunityBio’s recently approved immunotherapy for Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ. ANKTIVA was approved by the U.S. Food and Drug Administration (FDA) on April 22, 2024 for the treatment of patients with BCG-unresponsive NMIBC CIS with or without papillary tumors.

ImmunityBio, Inc. (NASDAQIBRX) announced today that its 2024 Annual Meeting of Stockholders will be held on Tuesday, June 11, 2024 at 9:30 a.m. Pacific Time. The Annual Meeting will be held in a virtual-only format and there will not be a physical location for the Annual Meeting. Stockholders of record at the close of business on April 17, 2024 are entitled to vote at and participate in the Annual Meeting.

ImmunityBio, Inc. (NASDAQIBRX) today announced the publication of three podcasts with UroToday highlighting the company’s recent FDA approval of ANKTIVA® (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) and advances in bladder cancer research.

ImmunityBio, Inc. (NASDAQIBRX) announced today that the drug substance (DS) has been completed and successfully qualified for “fill finish” (filling vials and finishing packaging), sufficient for 170,000 doses of 400mcg ANKTIVA (nogapendekin alfa inbakicept-pmln). Coupled with the recent announcement of a partnership with the Serum Institute of India (SII) for BCG availability, this provides the Company with a significant initial supply of ANKTIVA for commercial and clinical trial use in advance of the full operation of the Company’s own drug substance and fill-finish manufacturing plants in California and New York.

ImmunityBio, Inc. (NASDAQIBRX), has signed an exclusive global arrangement with the Serum Institute of India, the world’s largest manufacturer of vaccines by number of doses produced, to supply ImmunityBio with Bacillus Calmette-Guerin (BCG). The agreement covers the manufacturing of standard BCG (sBCG) that is currently approved for use outside the U.S., as well as a next-generation recombinant BCG (iBCG) undergoing testing, intended for use in combination with ImmunityBio’s ANKTIVA (nogapendekin alfa inbakicept-pmln) for currently approved and potential future indications, subject to regulatory approvals.

The Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio, Inc. (NASDAQIBRX), a next-generation immunotherapy company, will discuss the implications of the recent FDA approval of ANKTIVA® (nogapendekin alfa inbakicept-pmln) for use in combination with bacillus Calmette-Guerin (BCG) for non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors at the American Urological Association Annual Meeting (AUA 2024) this week in San Antonio, Texas.

ImmunityBio, Inc. (NASDAQIBRX), an immunotherapy company, today announced positive overall survival results in the QUILT 3.055 study of 2nd- and 3rd-line NSCLC patients who progressed after checkpoint inhibitor therapy (pembrolizumab, nivolumab, or atezolizumab) and standard-of-care chemotherapy to be discussed during the upcoming conference call. The results continue to reinforce ImmunityBio’s belief in the unique mechanism of action of ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) and its potential efficacy as a next-generation immunotherapy across multiple solid and liquid tumor types.

ImmunityBio, Inc. (NASDAQIBRX), an immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has approved ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.