ImmunityBio Submits Additional Info for BCG-Unresponsive NMIBC with 96% Survival Rate
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 20 2026
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Should l Buy IBRX?
Source: Newsfilter
- FDA Recommendation: Following discussions with the FDA, ImmunityBio is advised to submit additional information to support its supplemental Biologics License Application for BCG-unresponsive NMIBC, with submission expected within 30 days, without initiating new clinical trials.
- Long-term Survival Data: A study involving 80 patients shows that ANKTIVA treatment achieves approximately 96% bladder cancer-specific survival and over 80% bladder preservation at three years, highlighting the therapy's potential in high-risk populations.
- Global Approval Expansion: ANKTIVA has received approvals in the U.S., U.K., and Saudi Arabia, along with conditional marketing authorization in the EU, reflecting ImmunityBio's commitment to providing treatment options for patients unresponsive to BCG.
- Alternative Treatment Option: ImmunityBio aims to offer a bladder-sparing immunotherapy for high-grade NMIBC patients unresponsive to BCG, avoiding invasive surgeries, with long-term data suggesting ANKTIVA can delay or prevent the need for radical cystectomy.
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Analyst Views on IBRX
Wall Street analysts forecast IBRX stock price to rise
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 7.140
Low
5.00
Averages
7.33
High
9.00
Current: 7.140
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.
- Lawsuit Background: A class action lawsuit has been filed on behalf of investors who purchased ImmunityBio securities between January 19, 2026, and March 24, 2026, alleging that Executive Chairman Patrick Soon-Shiong materially overstated the capabilities of Anktivas, an FDA-approved immunotherapy, leading to investor losses.
- FDA Warning Letter: On March 24, 2026, the FDA issued a warning letter to ImmunityBio, stating that a TV ad and podcast were deemed “false or misleading,” and referenced previous Untitled Letters sent to its subsidiary Altor BioScience, indicating the company failed to rectify its promotional practices.
- Stock Price Impact: Following the FDA warning, ImmunityBio's stock price plummeted by 21.2%, from $9.40 per share on March 23, 2026, to $7.41, resulting in a loss of $1.99 per share, reflecting a pessimistic market outlook on the company's future.
- Investor Action Required: Investors must apply for lead plaintiff status by May 26, 2026, to represent other investors in the lawsuit, as the lead plaintiff will significantly influence litigation strategy and settlement, ensuring their rights are protected.
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- FDA Warning Letter: The FDA issued a warning letter to ImmunityBio, highlighting misleading claims made by Chairman Soon-Shiong regarding Anktiva's efficacy, resulting in a more than 21% drop in share price on March 24, 2026, erasing nearly $2 billion in market capitalization and severely impacting investor confidence.
- Class Action Lawsuit Initiated: Hagens Berman has filed a securities class action lawsuit against ImmunityBio on behalf of investors who purchased securities between January 19 and March 24, 2026, alleging violations of federal securities laws that may lead to further investor losses.
- Efficacy Claims Controversy: Soon-Shiong claimed in a podcast that Anktiva could treat all cancers, while the FDA stated that these promotional materials mislead the public and fail to provide complete information regarding Anktiva's FDA-approved indications, posing potential public health risks.
- Investor Rights Protection: Hagens Berman is urging investors who suffered significant losses to submit their information and encouraging witnesses to assist in the investigation, demonstrating a strong commitment to investor rights and a demand for greater corporate transparency.
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- Legal Investigation: Faruq & Faruqi LLP is investigating potential claims against ImmunityBio, specifically encouraging investors who purchased securities between January 19 and March 24, 2026, to seek lead plaintiff status by the May 26, 2026 deadline, thereby protecting their legal rights.
- False Statement Allegations: The lawsuit alleges that ImmunityBio and its executives violated federal securities laws by overstating Anktiva's capabilities, leading to investor losses when the true information was revealed, highlighting significant deficiencies in the company's transparency and compliance.
- Stock Price Impact: On January 23, 2026, ImmunityBio's announcement regarding its GBM clinical trial led to a stock price drop of $0.89, or 12.13%, closing at $6.45 per share, reflecting a significant decline in market confidence regarding the company's prospects.
- Investor Rights Protection: Faruq & Faruqi encourages anyone with information about ImmunityBio's conduct, including whistleblowers and former employees, to come forward to support affected investors, ensuring their rights are fully protected.
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- Class Action Initiated: Rosen Law Firm has filed a class action lawsuit on behalf of investors who purchased ImmunityBio securities between January 19 and March 24, 2026, alleging that the company made false and misleading statements during this period, potentially leading to investor losses.
- Compensation Mechanism: Investors participating in the class action may receive compensation without any out-of-pocket costs, indicating a risk-free remedy for affected investors and enhancing their confidence in pursuing legal action.
- Law Firm Background: Rosen Law Firm is renowned for its successful track record in securities class actions, having recovered over $438 million for investors in 2019 alone, showcasing its strength and experience in handling similar cases.
- Details of Allegations: The lawsuit claims that ImmunityBio executives materially overstated Anktiva's capabilities, leading to investor misunderstandings about the company's business prospects, reflecting potential governance and transparency issues within the company.
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- Class Action Initiation: Rosen Law Firm has filed a class action lawsuit on behalf of purchasers of ImmunityBio, Inc. (NASDAQ: IBRX) securities from January 19 to March 24, 2026, alleging that the company made false and misleading statements during this period, resulting in investor losses.
- Compensation Mechanism: Investors participating in the lawsuit may be entitled to compensation without any out-of-pocket fees, indicating a risk-free legal remedy for victims and potentially attracting more investors to join the action.
- Law Firm Background: Rosen Law Firm is renowned for its successful track record in securities class actions, having recovered over $438 million for investors in 2019 alone, showcasing its strength and experience in handling such cases.
- Details of Allegations: The lawsuit claims that ImmunityBio's executive Patrick Soon-Shiong materially overstated Anktiva's capabilities, leading to reputational damage for the company and financial losses for investors when the truth emerged, highlighting concerns over corporate governance and transparency.
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- Class Action Initiated: Bronstein, Gewirtz & Grossman, LLC has announced a class action lawsuit against ImmunityBio, aiming to recover damages for investors who purchased the company's securities between January 19, 2026, and March 24, 2026, highlighting concerns over potential investor losses.
- False Statement Allegations: The complaint alleges that ImmunityBio's executive Soon-Shion materially overstated Anktiva's capabilities, resulting in materially false and misleading statements regarding the company's business and prospects, which could significantly impact investor decisions.
- Investor Participation Opportunity: Affected investors have until May 26, 2026, to request to be appointed as lead plaintiff, indicating that the lawsuit provides an opportunity for investors to participate in claims without needing to serve as lead plaintiff.
- No-Risk Legal Services: Bronstein, Gewirtz & Grossman, LLC offers contingency fee-based legal services, meaning they will only charge fees if successful in recovering damages, ensuring financial safety for investors pursuing their losses.
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