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CULVER CITY, Calif. - ImmunityBio, Inc. (NASDAQ:IBRX), a $2.46 billion market cap immunotherapy company, has received authorization from the U.S. Food and Drug Administration (FDA) for an expanded access program (EAP) to supply a new Bacillus Calmette-Guérin (BCG) source for bladder cancer treatment in the U.S. This development comes as a response to the shortage of TICE® BCG, which has affected patient treatment in the past year. According to InvestingPro data, the company maintains a healthy current ratio of 2.68, indicating strong short-term financial stability despite rapid cash utilization.
The recombinant BCG (rBCG) vaccine, developed by the Serum Institute of India, demonstrated improved immunogenicity and safety in European clinical trials for non-muscle invasive bladder cancer (NMIBC). Dr. Patrick Soon-Shiong, Founder and Executive Chairman of ImmunityBio, emphasized the company’s commitment to addressing access issues for critical therapies. With analysts forecasting 24.61% revenue growth for fiscal year 2024, InvestingPro subscribers can access 8 additional key insights about the company’s growth trajectory.
The rBCG vaccine, which has undergone Phase 1/2 human clinical studies in Europe, is well-tolerated and has shown a safety profile similar to placebo. It has been modified genetically to enhance immunogenicity and safety compared to traditional BCG strains.
ImmunityBio has been granted multiple U.S. patents for the combination of BCG and ANKTIVA®, an interleukin-15 (IL-15) receptor agonist, in bladder cancer treatment. ANKTIVA was approved by the FDA in 2024 for BCG-unresponsive NMIBC.
The company is known for its efforts in developing therapies and vaccines that augment the natural immune system to combat cancers and infectious diseases. ImmunityBio’s platforms aim to create durable and safe protection against disease, with ANKTIVA designated as an FDA Breakthrough Therapy for NMIBC.
The press release also contains forward-looking statements regarding the timing of rBCG shipments, the EAP’s ability to provide a reliable BCG source, and potential benefits and outcomes for patients. These statements are based on current beliefs and assumptions and are subject to various risks and uncertainties. Notably, with a beta of -0.19, ImmunityBio’s stock often moves counter to market trends, making it an interesting diversification consideration. InvestingPro analysis suggests the stock may be slightly undervalued at current levels, though investors should note the company is not yet profitable.
The information in this article is based on a press release statement from ImmunityBio, Inc.
In other recent news, ImmunityBio, Inc. has made headlines with several significant developments. The company has disclosed new executive compensation arrangements, including cash bonuses and equity awards for top executives like Dr. Patrick Soon-Shiong and CEO Richard Adcock (JO:AIPJ). These bonuses are part of the company’s 2024 Executive Incentive Compensation Plan and will be paid in March 2025. Additionally, ImmunityBio announced the resignation of board member John Owen Brennan, which the company stated was not due to disagreements with its operations or policies.
In terms of regulatory progress, ImmunityBio reported substantial advancements in discussions with the FDA, focusing on treatments for non-muscle invasive bladder cancer and non-small cell lung cancer. The company plans to submit a supplemental Biologics License Application in 2025 for its treatment targeting BCG-unresponsive NMIBC. Furthermore, ImmunityBio has secured a unique permanent J-code for its bladder cancer treatment, ANKTIVA, facilitating the billing process for healthcare providers.
Analyst firm BTIG initiated coverage of ImmunityBio with a Buy rating, citing the potential of its lead product, ANKTIVA, and ongoing studies. The strategic partnership with the Serum Institute of India was also highlighted, aiming to address the BCG shortage. These developments reflect ImmunityBio’s ongoing efforts to advance its clinical pipeline and expand its market presence.
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