ImmunityBio Seeks ANKTIVA Label Expansion Amid Positive FDA Review
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 20 2026
0mins
Source: Newsfilter
ImmunityBio's stock rose by 7.35% as it crossed above the 5-day SMA, reflecting positive investor sentiment. The company announced that the U.S. FDA has accepted its supplemental Biologics License Application (sBLA) for ANKTIVA, aiming to expand its indication for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This decision, expected by January 6, 2027, is based on promising clinical data from the QUILT-3.032 trial, which showed a 12-month disease-free survival rate of 58.2% in high-risk patients treated with ANKTIVA plus BCG, indicating significant market potential for the expanded indication. The positive FDA review could enhance ImmunityBio's competitiveness in the bladder cancer treatment market.
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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: 7.720
Low
5.00
Averages
7.33
High
9.00
Current: 7.720
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.
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- Innovative Therapeutic Platform: The company holds exclusive rights to the TriKE platform designed to activate natural killer cells to directly attack tumors, leveraging technology from the University of Minnesota, showcasing immense potential in the tumor immunotherapy space that could transform existing treatment paradigms.
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- Clinical Progress: The lead candidate GTB-3650, targeting treatment-resistant blood cancers, has completed patient enrollment across four dose cohorts, with early safety assessments showing no dose-limiting toxicities, and a meaningful data update is expected in the second half of 2026.
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- Investment Outlook Analysis: While IBRX is viewed as a potential investment, analysts suggest that certain AI stocks may offer greater upside potential and lower risk, urging investors to carefully evaluate various investment opportunities to achieve optimal returns.
See More
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See More
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- Lawsuit Background: The lawsuit alleges that ImmunityBio made false and misleading statements during the class period, resulting in investor losses when the truth emerged, potentially impacting the company's reputation and future financing capabilities.
- Law Firm's Credentials: Rosen Law Firm specializes in securities class actions and has achieved the largest settlement against a Chinese company, ranked first by ISS Securities Class Action Services in 2017, demonstrating its expertise and success in this field.
See More
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- Market Valuation Struggles: As of mid-May 2026, GT Biopharma's market cap stood at approximately $13 million, indicating a significant undervaluation of this clinical-stage immuno-oncology company, prompting investors to consider potential value recovery.
- Significant Clinical Progress: GT Biopharma has advanced three TriKE candidates into clinical trials, with GTB-3650 targeting treatment-resistant blood cancers, and a critical data update expected in the second half of 2026, which could influence the company's future trajectory.
- Innovative Therapeutic Platform: The company holds exclusive rights to the TriKE platform designed to activate natural killer cells to directly attack tumors, leveraging technology from the University of Minnesota, showcasing immense potential in the tumor immunotherapy space that could transform existing treatment paradigms.
- Enormous Market Opportunity: The global oncology market is projected to grow from $139 billion in 2025 to $268 billion by 2034, and if GT Biopharma's product line succeeds, it could secure a significant position in this vast market, leading to substantial commercial returns.
See More
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- Market Valuation: As of May 2026, GT Biopharma's market capitalization stands at approximately $13 million, indicating significant undervaluation by the market despite having three drug candidates in human trials, suggesting a potential investment opportunity.
- Clinical Progress: The lead candidate GTB-3650, targeting treatment-resistant blood cancers, has completed patient enrollment across four dose cohorts, with early safety assessments showing no dose-limiting toxicities, and a meaningful data update is expected in the second half of 2026.
- New Drug Development: The first patient for GTB-5550 was dosed in May 2026, targeting the B7-H3 protein across multiple solid tumors, indicating a market potential significantly larger than that of the blood cancer drug, and it utilizes subcutaneous dosing for improved patient convenience.
- Market Outlook: The global oncology market is projected to grow from approximately $139 billion in 2025 to about $268 billion by 2034, positioning GT Biopharma's technology platform to potentially capture a significant share of this expansive market if successful.
See More
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- FDA Review Progress: On May 19, ImmunityBio announced that the FDA accepted its supplemental Biologics License Application for ANKTIVA® in combination with Bacillus Calmette-Guerin to treat BCG-unresponsive non-muscle invasive bladder cancer, with a target decision date of January 6, 2027, which could significantly expand the drug's label and enhance its market competitiveness.
- Significant Sales Growth: The company confirmed ANKTIVA sales at $44.2 million, reflecting a 15% quarter-over-quarter increase and a remarkable 168% year-over-year growth, indicating strong market demand and solidifying its position in the immunotherapy sector.
- Analyst Rating Update: Following the earnings release, BTIG lowered its price target for ImmunityBio from $13 to $12 while maintaining a Buy rating, demonstrating market confidence in the company's growth potential despite some downside risks.
- Investment Outlook Analysis: While IBRX is viewed as a potential investment, analysts suggest that certain AI stocks may offer greater upside potential and lower risk, urging investors to carefully evaluate various investment opportunities to achieve optimal returns.
See More
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- Super Micro Lawsuit: Super Micro Computer, Inc. (NASDAQ:SMCI) faces a class action for the period from April 30, 2024, to March 19, 2026, with investors claiming losses over $50,000 due to undisclosed sales to Chinese companies violating U.S. export laws, misleading shareholders about the company's operations.
- ImmunityBio Allegations: ImmunityBio, Inc. (NASDAQ:IBRX) is implicated in a class action for the period from January 19, 2026, to March 24, 2026, where executives allegedly overstated Anktiva's capabilities, leading to materially misleading statements about the company's prospects and significant investor losses.
- Pinterest Revenue Concerns: Pinterest, Inc. (NYSE:PINS) is involved in a class action for the period from February 7, 2025, to February 12, 2026, with claims that the company failed to disclose risks of declining advertising revenues, potentially facing imminent restructuring, which has severely impacted investors.
- Legal Consultation Recommendation: Investors suffering losses in the aforementioned companies are encouraged to contact The Law Offices of Frank R. Cruz to discuss their legal rights and ensure their interests are protected in the class actions.
See More
ImmunityBio Faces Securities Class Action Lawsuit
- FDA Warning Impact: The FDA issued a warning letter to ImmunityBio, citing misleading claims about Anktiva, which led to 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 Initiation: Hagens Berman has initiated a class action lawsuit on behalf of investors who purchased ImmunityBio securities between January 19 and March 24, 2026, alleging violations of federal securities laws and urging affected investors to submit their losses to support the investigation.
- Promotional Material Issues: The FDA highlighted that ImmunityBio's TV ads and podcast content were misleading, claiming Anktiva could cure all cancers without supporting data, which poses a potential public health risk and exacerbates legal vulnerabilities for the company.
- Investor Rights Protection: Hagens Berman emphasized its investigation into whether ImmunityBio intentionally misled investors and encouraged whistleblowers to provide information to assist the inquiry, demonstrating a commitment to protecting investor rights.
See More
Reminder for ImmunityBio Securities Class Action
- Class Action Notice: Rosen Law Firm reminds investors who purchased ImmunityBio (NASDAQ: IBRX) securities between January 19 and March 24, 2026, to apply as lead plaintiffs by May 26, 2026, to participate in the class action, as those who do not will not be represented.
- Fee Arrangement: Investors joining the class action will incur no out-of-pocket costs, as the law firm operates on a contingency fee basis, which alleviates financial burdens and encourages more victims to seek compensation.
- Lawsuit Background: The lawsuit alleges that ImmunityBio made false and misleading statements during the class period, resulting in investor losses when the truth emerged, potentially impacting the company's reputation and future financing capabilities.
- Law Firm's Credentials: Rosen Law Firm specializes in securities class actions and has achieved the largest settlement against a Chinese company, ranked first by ISS Securities Class Action Services in 2017, demonstrating its expertise and success in this field.
See More
