MedPath

ImmunityBio

ImmunityBio logo
🇺🇸United States
Ownership
Public, Subsidiary
Established
2014-01-01
Employees
628
Market Cap
$2.9B
Website
http://www.immunitybio.com
Introduction

ImmunityBio, Inc. is a clinical stage immunotherapy company. It develops next generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases. The company's immunotherapy platform activates both the innate and adaptive immune systems to create long term immunological memory. ImmunityBio was founded by Patrick Soon-Shiong in 2014 and is headquartered in San Diego, CA.

ImmunityBio Partners with Saudi Arabia to Bring FDA-Approved Cancer BioShield Platform to Middle East

ImmunityBio signed a strategic MOU with Saudi Arabia's Ministry of Investment, KFSHRC, and KAIMRC to introduce the FDA-approved Cancer BioShield platform to the Middle East region.

FDA Rejects ImmunityBio's Expanded Anktiva Application While Lifting Hold on Atara's Ebvallo Trials

ImmunityBio received an FDA "refusal to file" letter for its application to expand Anktiva's use in bladder cancer patients, causing a 25% stock plunge and prompting calls for agency clarification.

ImmunityBio Secures $75 Million in Equity Financing to Advance Immunotherapy Pipeline

ImmunityBio has executed a $75 million registered direct offering with a single institutional investor, providing crucial working capital for its ongoing operations.

ImmunityBio Achieves Multiple Milestones in Q1 2024, Advances ANKTIVA Development with RMAT Designation

• ImmunityBio reports significant progress with ANKTIVA's approval and permanent J-code assignment for treating BCG-unresponsive bladder cancer CIS, marking a major advancement in treatment options. • The company receives RMAT designation from FDA for ANKTIVA + PD-L1 t-haNK combination therapy for lymphopenia reversal, potentially transforming immunotherapy treatment approaches. • Strategic developments include EMA and MHRA submission acceptance, BeOne collaboration for checkpoint inhibitor supply, and expanded access to recombinant BCG amid TICE BCG shortage.

FDA Grants ImmunityBio Authorization to Supply Recombinant BCG Amid TICE BCG Shortage

ImmunityBio receives FDA authorization to provide recombinant BCG (rBCG) to urologists, addressing the critical TICE BCG shortage for bladder cancer treatment.

ImmunityBio and BeiGene Collaborate on Phase 3 Trial of ANKTIVA and Tislelizumab in NSCLC

ImmunityBio and BeiGene are collaborating on a Phase 3 trial (ResQ201A-NSCLC) to evaluate ANKTIVA plus BeiGene's tislelizumab in advanced NSCLC patients who have progressed on CPI therapy.

ImmunityBio Advances Anktiva for Bladder Cancer Treatment in US and Europe

ImmunityBio completed regulatory filings in the EU and UK for Anktiva with BCG for BCG-unresponsive NMIBC, with decisions expected by 2026.

ImmunityBio's Anktiva Pursues European and UK Approval for BCG-Unresponsive Bladder Cancer

ImmunityBio's Anktiva, combined with BCG, seeks approval in the EU and UK for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS).

Hoag Family Cancer Institute Advances Glioblastoma Treatment with Novel Clinical Trials

Hoag Family Cancer Institute is participating in the LIBERATE study, which uses Focused Ultrasound to temporarily open the blood-brain barrier for liquid biopsies in glioblastoma patients.

ANKTIVA Receives Permanent J-Code from CMS, Streamlining Reimbursement for Bladder Cancer Treatment

The Centers for Medicare & Medicaid Services (CMS) has assigned a permanent J-code (J9028) for ANKTIVA, effective January 1, 2025, to streamline billing.

© Copyright 2025. All Rights Reserved by MedPath