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12.12.2025
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ImmunityBio Receives Conditional Marketing Authorization Recommendation from the European Medicines Agency for ANKTIVA® with BCG for Non-Muscle Invasive Bladder Cancer Carcinoma in Situ—A First in Europe
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ImmunityBio (NASDAQ: IBRX), a leading immunotherapy company, announced today that the European Medicines Agency has recommended granting a conditional marketing authorization in the EU for ANKTIVA® (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder can...
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13.11.2025
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New Survey Reveals Non-Muscle Invasive Bladder Cancer Patients Seek More Care Conversations
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A new U.S. survey conducted by The Harris Poll on behalf of ImmunityBio, Inc. (NASDAQ: IBRX) reveals that many people living with non-muscle invasive bladder cancer (NMIBC) feel left out of critical treatment conversations. Fewer than one in five patients surveyed (18%) report their healthcare providers (HCPs) discuss all available treatment optio...
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05.11.2025
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Driven by Strong Demand, ImmunityBio Reports 467% Year-to-Date Unit Growth and $75 Million in Sales Year-to-Date, Up 434% from Q3 2024
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ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced its financial results for the fiscal quarter and nine months ended September 30, 2025.
In the third quarter of 2025, ImmunityBio reported $31.8 million of product revenue, representing a 434% increase from $6.0 million in the third quarter of 2024. This growth refl...
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08.09.2025
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ImmunityBio’s ANKTIVA® Reverses Lymphopenia and Extends Overall Survival in Patients With Advanced Non-Small Cell Lung Cancer Resistant to Checkpoint Therapy
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ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced new paradigm changing findings from the Phase 2 QUILT-3.055 study, demonstrating ANKTIVA® (nogapendekin alfa inbakicept-pmln) reverses lymphopenia (low natural killer and T cells) in patients with checkpoint inhibitor-resistant advanced non-small cell lung cancer (N...
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19.08.2025
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ImmunityBio Announces Phase 2 Study of ANKTIVA® in Patients with Long COVID
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ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the opening of a new Phase 2 study to assess the BioShield™ platform, anchored by ANKTIVA® (nogapendekin alfa inbakicept-pmln), in patients with long COVID. An estimated one in five Americans with a previous COVID-19 infection has long COVID, which is comprised of a...
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13.08.2025
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ImmunityBio Reports Complete Responses in Non-Hodgkin Waldenstrom Lymphoma Patients with Chemotherapy-Free, First-In-Class CD19 CAR-NK Immunotherapy
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ImmunityBio (NASDAQ: IBRX), a leading immunotherapy company, announced today early findings from its QUILT-106 Phase I trial, showing highly promising complete responses in the first two patients treated to date with late-stage Waldenstrom macroglobulinemia (WM)—a type of non-Hodgkins lymphoma (NHL)—using its CD19 CAR-NK (CD19 t-haNK) natural kill...
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25.07.2025
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ImmunityBio, Inc. Announces Execution of $80 Million Equity Financing from Multiple Institutional Investors
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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 two institutional investors, providing for the issuance of c...
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25.07.2025
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ImmunityBio Reports 60% Increase in Revenue in Q2 2025, with Year-to-Date Sales of $43 Million and 246% Unit Growth Since J-Code with Regulatory Updates
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ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced preliminary financial results for the fiscal quarter ended June 30, 2025, and clinical progress across its pipeline.
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Q2 2025 Revenue Growth with Continued Strong Sales Momentum: $26.4 million, up 60% from Q1 2025, with year-to-date sales of ~$43...
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08.07.2025
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UK MHRA Approves ImmunityBio’s ANKTIVA® Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ
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ImmunityBio, Inc. (NASDAQ: IBRX) today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of certain bladder cancer patients. This is the first marketing approval ou...
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03.06.2025
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ASCO Report of Pioneering Treatment of Lymphopenia with Significant Overall Survival Benefit in Advanced Pancreatic Cancer
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ImmunityBio, Inc. (NASDAQ: IBRX) today announced results presented at ASCO 2025 of the first known treatment for lymphopenia with ANKTIVA and CAR-NK therapy. This data supports that reversal of lymphopenia, a well-established root cause of early mortality in patients with cancer across all tumor types, correlates with significant improved survival...
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02.06.2025
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ImmunityBio Receives FDA Expanded Access Authorization for Landmark Treatment of Lymphopenia With ANKTIVA®, the Cancer BioShield™ Platform, in Patients With Solid Tumors
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ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has granted Expanded Access authorization for the use of its Cancer BioShield™ platform, anchored by ANKTIVA® (nogapendekin alfa inbakicept-pmln), to treat lymphopenia in adult patients with refractory or relapsed sol...
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27.05.2025
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ImmunityBio, Saudi Arabia’s Ministry of Investment, KFSHRC, and KAIMRC Sign Strategic Memorandum of Understanding to Launch Cancer BioShield™ Platform in the Middle East
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ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the signing of a strategic Memorandum of Understanding (MOU) with the Ministry of Investment of Saudi Arabia (MISA), King Faisal Specialist Hospital & Research Centre (KFSHRC), and King Abdullah International Medical Research Center (KAIMRC). This multi-party co...
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12.05.2025
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ImmunityBio Reports Doubled Net Revenue and 150% Unit Growth in Q1 2025, With Continued Strong Sales Momentum in First Quarter since J-code
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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 first-quarter ended March 31, 2025.
With the issuance of the permanent J-code (J9028) in January 2025, ImmunityBio has seen incr...
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05.05.2025
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ImmunityBio Requests an Urgent Meeting With FDA to Address the Change in the Agency’s Unambiguous Guidance on Jan 2025 to Submit a sBLA for NMIBC BCG Unresponsive Papillary Disease, Following an Inconsistent Refusal to File Letter on May 2, 2025
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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...
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28.04.2025
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Unmatched Long-Term Bladder Preservation for 36 Months in over 80 percent of Responders with ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC CIS and Papillary Disease Alone – Best in Disease and Best in Class with 5 Year Follow-Up
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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), wi...
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21.04.2025
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ImmunityBio to Showcase Advances for Bladder and Prostate Cancer at American Urological Association (AUA) Annual Meeting
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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,...
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15.04.2025
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ImmunityBio Announces FDA Submissions of Supplemental BLA for NMIBC Papillary Disease and for Expanded Access of ANKTIVA® to Treat Lymphopenia
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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.
Supplemental Biologics License Application (sBLA):...
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08.04.2025
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ImmunityBio Announces Execution of $75 Million Equity Financing with an Institutional Investor
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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...
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07.04.2025
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ImmunityBio to Host Key Opinion Leader and Investor Meeting to Provide Updates on Clinical Programs and ANKTIVA Commercial Launch
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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 h...
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26.03.2025
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ImmunityBio to Host Investor Day
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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 can...
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13.03.2025
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ImmunityBio Announces First Dosing of Recombinant BCG (rBCG) in the U.S. and 60 Sites Are in the Process of Launching
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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...
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03.03.2025
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ImmunityBio Reports Sales Momentum & Unit Growth Since Permanent J-code Issuance (J9028) in January 2025 and Financial Results for Year End 2024
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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.
With the issuance of the permanent J-code in January 2025, ImmunityBio ha...
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28.02.2025
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ImmunityBio Receives FDA RMAT Designation for ANKTIVA® and CAR-NK for the Reversal of Lymphopenia in Patients Receiving Standard-of-Care Chemotherapy/Radiotherapy and in Treatment of Multiply Relapsed Locally Advanced or Metastatic Pancreatic Cancer
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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...
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19.02.2025
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FDA Authorizes ImmunityBio to Provide Recombinant BCG (rBCG) to Urologists to Address TICE® BCG Shortage
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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.
Supply shortages of TICE® BCG in the U.S. have beco...
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13.02.2025
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ImmunityBio Announces UK Medicines and Healthcare Products Regulatory Agency Accepted Marketing Authorization Application for ANKTIVA® for the Treatment of Patients with BCG-unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ
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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 inbakice...
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29.01.2025
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ImmunityBio Announces Collaboration with BeiGene on Confirmatory Phase 3 Trial of ANKTIVA® and PD-1 Checkpoint Inhibitor Combination in Non-Small Cell Lung Cancer
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ImmunityBio, Inc. (NASDAQ: IBRX) 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 Immu...
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27.01.2025
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ImmunityBio Announces European Medicines Agency Acceptance of Marketing Authorization Application for ANKTIVA® for the Treatment of Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ
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ImmunityBio, Inc. (NASDAQ: IBRX), 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-un...
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15.01.2025
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ImmunityBio Provides Regulatory Update on Global Submission for ANKTIVA + BCG in BCG Unresponsive Non-Muscle Invasive Bladder Cancer with Carcinoma in situ in Europe and United Kingdom
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ImmunityBio, Inc. (NASDAQ: IBRX) 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...
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15.01.2025
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ImmunityBio Provides Regulatory Update on Anticipated FDA Submissions in 2025 Following Meeting with the Agency
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ImmunityBio, Inc. (NASDAQ: IBRX), 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).
NMIBC BCG Unresponsive...
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06.01.2025
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ImmunityBio Announces Permanent J-code (J9028) for ANKTIVA® Is Now Effective
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ImmunityBio, Inc. (NASDAQ: IBRX), 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...
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11.12.2024
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ImmunityBio, Inc. Announces Pricing of Public Offering of Common Stock
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ImmunityBio, Inc. (NASDAQ: IBRX), 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,...
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10.12.2024
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ImmunityBio, Inc. Announces Proposed Public Offering of Common Stock
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ImmunityBio, Inc. (NASDAQ: IBRX), 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...
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21.11.2024
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ImmunityBio and nCartes Enter Collaboration Agreement on Clinical Trial Data Fulfillment
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FREMONT, Calif., Nov. 21, 2024 /PRNewswire/ -- ImmunityBio, Inc. (NASDAQ: IBRX), a vertically integrated biotechnology company, and nCartes, Inc., a transformational cloud software platform provider, announced a collaboration agreement aimed at automating and streamlining the data fulfillment process for clinical trials. The goal of the collabora...
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19.11.2024
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ImmunityBio Completes ANKTIVA’s Post-Approval Enrollment of the 100th Patient in BCG Unresponsive NMIBC CIS Trial and Reports a Complete Response Rate of 71% with a Durable Duration of Response Ranging Up to 54 Months
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ImmunityBio, Inc. (NASDAQ: IBRX), 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 inbaki...
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12.11.2024
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ImmunityBio Reports Third-Quarter 2024 Financial Results
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ImmunityBio, Inc. (NASDAQ: IBRX) today announced its financial results for the third-quarter ended September 30, 2024.
ANKTIVA® received a J-code (HCPCS Level II Code) in October 2024, effective January 1, 2025.
ANKTIVA (FDA-approved and commercially available in the U.S. since May 2024) is now widely accessible to patients through commercia...
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24.10.2024
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First Patients Dosed in Phase 1 Clinical Study of ImmunityBio’s CAR-NK Cell Therapy for the Treatment of Relapsed B-Cell Non-Hodgkin Lymphoma
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Immunotherapy innovator ImmunityBio, Inc. (NASDAQ: IBRX), 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 bei...
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21.10.2024
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ImmunityBio to Participate in the Jefferies London Healthcare Conference
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Immunotherapy innovator ImmunityBio, Inc. (NASDAQ: IBRX), 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.
Details of the presentation can be found below.
Jefferies London Healthcare Conference
Date:
Tuesday, Novem...
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09.09.2024
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ImmunityBio Presents Positive Long-Term Overall Survival Data in Non-Small Cell Lung Cancer Patients and Announces Registrational Intent Phase 3 Trials with ANKTIVA® and Checkpoint Immunotherapy at World Conference on Lung Cancer
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Immunotherapy innovator ImmunityBio, Inc. (NASDAQ: IBRX), 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 pres...
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12.08.2024
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ImmunityBio’s ANKTIVA® Now Covered By More Than a Dozen Insurance Plans Representing Over 100 Million Lives Within Months of FDA Approval
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ImmunityBio, Inc. (NASDAQ: IBRX), 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....
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