ImmunityBio Partners with Japan BCG Laboratory for Tokyo Strain
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 39 minutes ago
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Should l Buy IBRX?
Source: Newsfilter
- Clinical Trial Success: The SWOG S1602 trial, sponsored by the National Cancer Institute, demonstrated that the Tokyo strain of BCG is non-inferior to TICE BCG in treating high-grade non-muscle invasive bladder cancer, with a hazard ratio of 0.82 against a pre-specified margin of 1.34, validating its efficacy.
- Exclusive Development Agreement: ImmunityBio has signed an exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory, granting rights to develop, import, and commercialize the Tokyo strain of BCG, aiming to address the long-standing BCG shortage in the U.S. and significantly improve treatment options for patients.
- FDA Engagement Plans: ImmunityBio plans to engage with the FDA to expedite the approval process for the Tokyo strain of BCG, acting as the sole Biologics License Application applicant, which, if approved, will solidify its position in the bladder cancer treatment market.
- Ongoing Partnerships: The collaboration with Serum Institute of India ensures the availability of recombinant BCG (rBCG) under the FDA Expanded Access Program for eligible patients, aiming to alleviate the BCG shortage in the U.S. through dual supply sources.
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Analyst Views on IBRX
Wall Street analysts forecast IBRX stock price to fall
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 8.150
Low
5.00
Averages
7.33
High
9.00
Current: 8.150
Low
5.00
Averages
7.33
High
9.00
About IBRX
Immunitybio, Inc. is a vertically integrated, clinical-stage biotechnology company developing therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. Using its applied science and platforms to treat cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies to reduce or eliminate the need for standard high-dose chemotherapy. Its platforms and their associated product candidates are designed to attack cancer and infectious pathogens by activating both the innate immune system, including NK cells, dendritic cells, and macrophages, as well as the adaptive immune system comprising B and T cells, in an orchestrated manner. Its platforms for the development of biologic product candidates include antibody-cytokine fusion proteins, vaccine vectors, and cell therapies. Its biologic commercial product candidate, Anktiva, is an IL-15 superagonist antibody-cytokine fusion protein.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
ImmunityBio Partners with Japan BCG Laboratory for Tokyo Strain
- Clinical Trial Success: The SWOG S1602 trial, sponsored by the National Cancer Institute, demonstrated that the Tokyo strain of BCG is non-inferior to TICE BCG in treating high-grade non-muscle invasive bladder cancer, with a hazard ratio of 0.82 against a pre-specified margin of 1.34, validating its efficacy.
- Exclusive Development Agreement: ImmunityBio has signed an exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory, granting rights to develop, import, and commercialize the Tokyo strain of BCG, aiming to address the long-standing BCG shortage in the U.S. and significantly improve treatment options for patients.
- FDA Engagement Plans: ImmunityBio plans to engage with the FDA to expedite the approval process for the Tokyo strain of BCG, acting as the sole Biologics License Application applicant, which, if approved, will solidify its position in the bladder cancer treatment market.
- Ongoing Partnerships: The collaboration with Serum Institute of India ensures the availability of recombinant BCG (rBCG) under the FDA Expanded Access Program for eligible patients, aiming to alleviate the BCG shortage in the U.S. through dual supply sources.
See More
ImmunityBio Secures Exclusive U.S. Rights for Bladder Cancer Therapy
- Licensing Agreement: ImmunityBio has secured a licensing deal with Japan BCG Laboratory to acquire exclusive U.S. rights for the bladder cancer treatment Bacillus Calmette-Guerin (BCG), marking a strategic expansion in the oncology sector.
- Clinical Trial Results: The Phase 3 trial results from February indicated that Tokyo strain BCG is non-inferior to FDA-approved TICE BCG in treating BCG-naïve high-grade non-muscle-invasive bladder cancer, enhancing the therapy's market potential.
- Market Expansion: Currently, ImmunityBio markets its immunotherapy Anktiva in the U.S. and plans to integrate the Tokyo strain BCG into its product offerings, which is expected to bolster the company's competitive position in the bladder cancer treatment market.
- Regulatory Submission Plans: As part of the agreement, ImmunityBio will file regulatory submissions to seek FDA approval and commercialization of the Tokyo strain BCG, demonstrating the company's commitment to new therapies and its intent to expand in the U.S. market.
See More
ImmunityBio Faces Securities Class Action Lawsuit
- Lawsuit Background: ImmunityBio is facing a securities class action lawsuit due to misleading efficacy claims made by its Chief Scientific Officer regarding Anktiva, affecting investors who purchased shares between January 19 and March 24, 2026.
- FDA Warning Letter: The FDA issued a warning letter to ImmunityBio, stating that promotional materials falsely suggested Anktiva could treat all cancers, with no supporting data, which severely undermines the company's credibility.
- Stock Price Plunge: Following this news, ImmunityBio's stock price dropped over 21% on March 24, 2026, erasing nearly $2 billion in market capitalization, indicating significant market concern about the company's future prospects.
- Investor Rights: Hagens Berman is investigating whether ImmunityBio intentionally misled investors, urging those who suffered substantial losses to report their losses for potential legal recourse.
See More
ImmunityBio's Soon-Shiong to Address BCG Shortages at AUA Meeting
- BCG Shortage Challenge: ImmunityBio's founder Patrick Soon-Shiong is set to discuss the ongoing shortages of Bacillus Calmette–Guérin (BCG) therapy at the American Urological Association meeting, emphasizing that Merck is the sole global supplier, which limits treatment options and impacts patient outcomes.
- Anktiva Expansion Application: Earlier this year, ImmunityBio resubmitted a supplemental biologics license application seeking to expand Anktiva's indications; however, the FDA's decision is still pending, and the drug can only be used in conjunction with BCG, limiting its market potential.
- Global Market Expansion: ImmunityBio launched Anktiva in Saudi Arabia and has received approvals in the UK, EU, and Macau, with Soon-Shiong hinting at potential expansion plans in Turkey, indicating the company's proactive approach to global market penetration.
- Investor Sentiment Shift: Despite IBRX shares surging over 275% this year, retail sentiment on social media shifted from 'extremely bullish' to 'bullish', reflecting cautious optimism regarding FDA approval and the company's future prospects.
See More
MiNK Therapeutics Initiates Phase 2 Trial for agenT-797 in Severe Lung Injury
- Trial Initiation: MiNK Therapeutics has launched a randomized Phase 2 clinical trial for agenT-797, targeting severe acute lung injury and critical illness, with preliminary data expected in the second half of 2026, which will provide crucial insights for further development of the drug.
- Biological Rationale Strengthened: Presentations at AACR and ASGCT highlighted the durable survival and context-dependent activity of iNKT cells, particularly showing a 77% disease control rate and over 20 months of long-term survival in PD-1 refractory gastroesophageal cancer patients, underscoring its clinical potential.
- Capital Efficiency Improvement: MiNK secured approximately $1.1 million in non-dilutive funding through a collaboration with C-Further to advance a PRAME-targeted TCR-engineered iNKT cell therapy for pediatric cancers, a strategy that not only reduces capital burden but also offers potential downstream commercial revenue opportunities.
- Financial Update: As of Q1 2026, MiNK reported approximately $9.5 million in cash and cash equivalents, down from $13.4 million at the end of 2025, although net loss slightly decreased to $2.74 million, indicating the company's ongoing commitment to advancing high-priority clinical programs.
See More
ImmunityBio Faces Class Action Lawsuit and FDA Warning
- Class Action Filed: Pomerantz LLP has initiated a class action lawsuit against ImmunityBio, alleging securities fraud and other unlawful business practices, with investors urged to apply as Lead Plaintiff by May 26, 2026, to protect their interests.
- FDA Warning Letter: A warning letter from the FDA, made public on March 24, 2026, asserts that ImmunityBio continues to promote its bladder cancer drug Anktiva in a misleading manner despite prior warnings, which could severely impact the company's reputation.
- Stock Price Plunge: Following the FDA warning, ImmunityBio's stock price plummeted by 21.12% on March 24, 2026, dropping $1.99 to close at $7.41, reflecting market concerns over the company's compliance and future outlook.
- Law Firm's Reputation: Pomerantz LLP, a premier class action law firm with over 85 years of experience, specializes in securities fraud and corporate misconduct cases, having secured multimillion-dollar settlements for victims, highlighting its significant influence in the legal field.
See More
ImmunityBio Partners with Japan BCG Laboratory for Tokyo Strain
- Clinical Trial Success: The SWOG S1602 trial, sponsored by the National Cancer Institute, demonstrated that the Tokyo strain of BCG is non-inferior to TICE BCG in treating high-grade non-muscle invasive bladder cancer, with a hazard ratio of 0.82 against a pre-specified margin of 1.34, validating its efficacy.
- Exclusive Development Agreement: ImmunityBio has signed an exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory, granting rights to develop, import, and commercialize the Tokyo strain of BCG, aiming to address the long-standing BCG shortage in the U.S. and significantly improve treatment options for patients.
- FDA Engagement Plans: ImmunityBio plans to engage with the FDA to expedite the approval process for the Tokyo strain of BCG, acting as the sole Biologics License Application applicant, which, if approved, will solidify its position in the bladder cancer treatment market.
- Ongoing Partnerships: The collaboration with Serum Institute of India ensures the availability of recombinant BCG (rBCG) under the FDA Expanded Access Program for eligible patients, aiming to alleviate the BCG shortage in the U.S. through dual supply sources.
See More
ImmunityBio Secures Exclusive U.S. Rights for Bladder Cancer Therapy
- Licensing Agreement: ImmunityBio has secured a licensing deal with Japan BCG Laboratory to acquire exclusive U.S. rights for the bladder cancer treatment Bacillus Calmette-Guerin (BCG), marking a strategic expansion in the oncology sector.
- Clinical Trial Results: The Phase 3 trial results from February indicated that Tokyo strain BCG is non-inferior to FDA-approved TICE BCG in treating BCG-naïve high-grade non-muscle-invasive bladder cancer, enhancing the therapy's market potential.
- Market Expansion: Currently, ImmunityBio markets its immunotherapy Anktiva in the U.S. and plans to integrate the Tokyo strain BCG into its product offerings, which is expected to bolster the company's competitive position in the bladder cancer treatment market.
- Regulatory Submission Plans: As part of the agreement, ImmunityBio will file regulatory submissions to seek FDA approval and commercialization of the Tokyo strain BCG, demonstrating the company's commitment to new therapies and its intent to expand in the U.S. market.
See More
ImmunityBio Faces Securities Class Action Lawsuit
- Lawsuit Background: ImmunityBio is facing a securities class action lawsuit due to misleading efficacy claims made by its Chief Scientific Officer regarding Anktiva, affecting investors who purchased shares between January 19 and March 24, 2026.
- FDA Warning Letter: The FDA issued a warning letter to ImmunityBio, stating that promotional materials falsely suggested Anktiva could treat all cancers, with no supporting data, which severely undermines the company's credibility.
- Stock Price Plunge: Following this news, ImmunityBio's stock price dropped over 21% on March 24, 2026, erasing nearly $2 billion in market capitalization, indicating significant market concern about the company's future prospects.
- Investor Rights: Hagens Berman is investigating whether ImmunityBio intentionally misled investors, urging those who suffered substantial losses to report their losses for potential legal recourse.
See More
ImmunityBio's Soon-Shiong to Address BCG Shortages at AUA Meeting
- BCG Shortage Challenge: ImmunityBio's founder Patrick Soon-Shiong is set to discuss the ongoing shortages of Bacillus Calmette–Guérin (BCG) therapy at the American Urological Association meeting, emphasizing that Merck is the sole global supplier, which limits treatment options and impacts patient outcomes.
- Anktiva Expansion Application: Earlier this year, ImmunityBio resubmitted a supplemental biologics license application seeking to expand Anktiva's indications; however, the FDA's decision is still pending, and the drug can only be used in conjunction with BCG, limiting its market potential.
- Global Market Expansion: ImmunityBio launched Anktiva in Saudi Arabia and has received approvals in the UK, EU, and Macau, with Soon-Shiong hinting at potential expansion plans in Turkey, indicating the company's proactive approach to global market penetration.
- Investor Sentiment Shift: Despite IBRX shares surging over 275% this year, retail sentiment on social media shifted from 'extremely bullish' to 'bullish', reflecting cautious optimism regarding FDA approval and the company's future prospects.
See More
MiNK Therapeutics Initiates Phase 2 Trial for agenT-797 in Severe Lung Injury
- Trial Initiation: MiNK Therapeutics has launched a randomized Phase 2 clinical trial for agenT-797, targeting severe acute lung injury and critical illness, with preliminary data expected in the second half of 2026, which will provide crucial insights for further development of the drug.
- Biological Rationale Strengthened: Presentations at AACR and ASGCT highlighted the durable survival and context-dependent activity of iNKT cells, particularly showing a 77% disease control rate and over 20 months of long-term survival in PD-1 refractory gastroesophageal cancer patients, underscoring its clinical potential.
- Capital Efficiency Improvement: MiNK secured approximately $1.1 million in non-dilutive funding through a collaboration with C-Further to advance a PRAME-targeted TCR-engineered iNKT cell therapy for pediatric cancers, a strategy that not only reduces capital burden but also offers potential downstream commercial revenue opportunities.
- Financial Update: As of Q1 2026, MiNK reported approximately $9.5 million in cash and cash equivalents, down from $13.4 million at the end of 2025, although net loss slightly decreased to $2.74 million, indicating the company's ongoing commitment to advancing high-priority clinical programs.
See More
ImmunityBio Faces Class Action Lawsuit and FDA Warning
- Class Action Filed: Pomerantz LLP has initiated a class action lawsuit against ImmunityBio, alleging securities fraud and other unlawful business practices, with investors urged to apply as Lead Plaintiff by May 26, 2026, to protect their interests.
- FDA Warning Letter: A warning letter from the FDA, made public on March 24, 2026, asserts that ImmunityBio continues to promote its bladder cancer drug Anktiva in a misleading manner despite prior warnings, which could severely impact the company's reputation.
- Stock Price Plunge: Following the FDA warning, ImmunityBio's stock price plummeted by 21.12% on March 24, 2026, dropping $1.99 to close at $7.41, reflecting market concerns over the company's compliance and future outlook.
- Law Firm's Reputation: Pomerantz LLP, a premier class action law firm with over 85 years of experience, specializes in securities fraud and corporate misconduct cases, having secured multimillion-dollar settlements for victims, highlighting its significant influence in the legal field.
See More
