ImmunityBio Inc is a biotechnology company focused on developing innovative immunotherapy treatments to harness the body's immune system in the fight against cancer and infectious diseases. The company specializes in the discovery and commercialization of novel therapies that aim to stimulate an immune response, with a particular emphasis on enhancing the effectiveness of existing cancer treatments. By leveraging cutting-edge research and technology, ImmunityBio is dedicated to improving patient outcomes and finding breakthrough solutions for complex medical challenges. Read More
ImmunityBio received an RTF letter regarding a supplemental biologics license application it filed for the use of ANKTIVA plus Bacillus Calmette-Guerin (BCG) in a specific case scenario of non-muscle invasive bladder cancer (NMIBC).
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced that the Company received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for the supplemental biologics license application (sBLA) for use of ANKTIVA plus Bacillus Calmette-Guerin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) for the indication of papillary disease. This RTF letter was received despite reaching unanimous guidance and encouragement at the in-person January 2025 meeting from the leadership of the Agency, including from CBER, CDER and OCE to submit this sBLA. At this meeting all key decision makers were specifically asked and unanimously confirmed that ImmunityBio should submit the sBLA as soon as possible based on the data in the single-arm trial. Relying on this unanimous guidance the Company submitted the sBLA in March 2025. The Company has already requested an urgent meeting to resolve the inconsistencies between the directives provided at the January Meeting and receipt of the RTF letter.
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced positive long-term results from its QUILT-3.032 study of ANKTIVA® (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary disease. The findings were shared during an oral presentation at the American Urological Association Annual Meeting (AUA 2025) in Las Vegas, April 26-29.
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, will announce new clinical findings for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS) and updated data on papillary disease without CIS at the American Urological Association Annual Meeting (AUA 2025) in Las Vegas, April 26-29. The company will also host an educational and peer-networking event to discuss ImmunityBio’s approach to treatment of NMIBC CIS and papillary disease and how they have impacted patients.
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced that it has completed multiple submissions to the FDA including an sBLA for BCG-unresponsive NMIBC in papillary disease and an EAP for ANKTIVA® (nogapendekin alfa inbakicept-pmln) for the treatment of lymphopenia.
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced that it has executed financing to provide further working capital and support its ongoing business operations. The Company entered into a securities purchase agreement for a registered direct offering with a single institutional investor, providing for the issuance of common stock of ImmunityBio as well as warrants for the purchase of additional shares of common stock of ImmunityBio that is expected to result in gross proceeds at closing of approximately $75 million before deducting any offering-related expenses, subject to customary closing conditions. If fully exercised, the warrants could result in additional gross proceeds of up to approximately $90 million.
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced details about its Investor Day program to be held on Tuesday, April 15, 2025, at 10:00 am PDT. The program will include an in-depth update on the company’s business operations, U.S. and global regulatory advances of its clinical-stage products, with fireside chats hosted by Dr. Patrick Soon-Shiong and key opinion leaders involved in the company’s research programs.
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, invites current and prospective investors to its Investor Day program to be held on Tuesday, April 15, 2025, at 10:00 am PDT. The program will include an in-depth update on the company’s business operations and recent R&D advancements. Key timelines for catalysts of product candidates will be presented, along with a discussion of ongoing clinical trials.
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced U.S. Urology Partners, one of the nation’s largest independent providers of urology and related specialty services, is one of the first providers to participate in ImmunityBio’s Expanded Access Program (EAP) for recombinant Bacillus Calmette-Guérin (rBCG) to address the current shortage of TICE® BCG in the U.S.
HC Wainwright initiates coverage on ImmunityBio with a Buy rating, citing Anktiva's growth potential. The firm projects $4.3 billion in sales, up from $137M in 2025.
Stocks fell broadly on Monday to start the month of March with all three major indices red in midday trading. Investors digested a decline in February's ISM Manufacturing PMI data which fell to 50.3%, down from 50.9% in January.
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced certain operational results following approval of the permanent J-code (J9028) in January 2025, as well as its financial results for the fourth-quarter and full year ended December 31, 2024.
NEW YORK , Feb. 27, 2025 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against ImmunityBio, Inc. (NASDAQ: IBRX) on behalf of long-term stockholders following a class action complaint that was filed against ImmunityBio on August 29, 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.
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for ANKTIVA® and CAR-NK (PD-L1 t-haNK) for the reversal of Lymphopenia in Patients Receiving Standard-of-Care Chemotherapy/Radiotherapy and in Multiply Relapsed Locally Advanced or Metastatic Pancreatic Cancer.
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the U.S. Food and Drug Administration (FDA) has authorized an expanded access program (EAP) that will bring a vital alternative source of BCG, a standard-of-care medicine in bladder cancer, to patients in the U.S.
Vancouver, BC – February 18, 2025 – USA News Group News Commentary – Despite optimism coming from the launch of Project Stargate (a $500 billion investment in AI data centers), there is still cause for alarm regarding soaring cancer rates around the world, especially among young people. Lifestyle factors are gaining more attention, as the […]
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunity therapy company, today announced the Medicines and Healthcare products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application for ANKTIVA. The MHRA will now begin 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. MHRA regulates medicines, medical devices and blood components for transfusion in the UK.
