ImmunityBio Submits Anktiva Application Acknowledged by FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
0mins
Should l Buy IBRX?
ImmunityBio announced that the U.S. FDA has acknowledged receipt of its supplemental Biologics License Application for Anktiva plus Bacillus Calmette-Guerin in BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors. The resubmission follows ongoing discussions with the FDA beginning in January 2026, during which the Agency requested additional data to support its review. The request did not include the initiation or design of any new clinical trials. ImmunityBio submitted the requested information in February 2026. After reviewing the additional data, the FDA provided feedback in March requesting updated efficacy data. The company subsequently resubmitted the sBLA for patients with papillary-only NMIBC, including updated long-term follow-up data, and the Agency has acknowledged receipt of the filing.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy IBRX?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
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: 8.010
Low
5.00
Averages
7.33
High
9.00
Current: 8.010
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 Advances Global NK Cell Bank Initiative
- NK Cell Production Data: Soon-Shiong highlighted upcoming data on large-scale production and cryopreservation of billions of natural killer (NK) cells, aiming to rekindle investor interest despite IBRX shares facing over 5% decline over six consecutive sessions.
- FDA Resubmission: ImmunityBio resubmitted its FDA application on Monday to expand Anktiva's use for early bladder cancer patients unresponsive to BCG therapy, with the updated filing including long-term follow-up results showing 58.2% of patients remained cancer-free after 12 months.
- AI Robot for Production: The company plans to utilize an AI-driven robot named Leonardo to automate NK cell production, aiming to store trillions of NK cells and develop CAR-NK cell therapies for global off-the-shelf treatment options.
- Market Sentiment Analysis: Despite IBRX stock surging over 300% year-to-date, retail sentiment on Stocktwits remains bearish, indicating concerns about the long-term outlook for the company amidst low message volume.
See More
Analysis of the Appeal of Heavily Shorted Stocks
- Short Interest Analysis: Many traders focus on heavily shorted stocks as they are perceived to carry potential downside risks, particularly when companies face challenges like disappointing earnings and persistent cash burn, which could lead to stock price declines.
- Short Squeeze Mechanics: A short squeeze is a rapid, feedback-driven price increase often triggered by unexpected positive catalysts, such as stronger-than-expected earnings or improved guidance, forcing short sellers to cover their positions, which further drives up the stock price.
- Characteristics of Heavily Shorted Stocks: Heavily shorted stocks typically belong to companies with market caps above $2 billion, average 14-day trading volumes exceeding 5 million shares, and free floats above 5 million shares, attracting significant attention from professional traders due to high short interest.
- Market Dynamics Impact: High short interest not only draws the attention of institutional investors but also piques the interest of retail and momentum traders, who believe that once the stock begins to rebound, short sellers will be forced to cover, accelerating the stock price increase.
See More
ImmunityBio Resubmits ANKTIVA Application to FDA Amid Stock Fluctuations
- FDA Resubmission: ImmunityBio has announced the resubmission of its supplemental Biologics License Application for ANKTIVA to the FDA, aimed at treating BCG-unresponsive non-muscle invasive bladder cancer, reflecting the company's proactive response to regulatory requirements during ongoing discussions with the agency.
- Stock Dynamics: ImmunityBio's shares are currently priced at $8.53, trading 1.3% below the 20-day simple moving average but 41.3% above the 100-day moving average, indicating a strong long-term trend despite facing some selling pressure in the short term.
- Analyst Ratings: The stock carries a Buy rating with an average price target of $12.50, with Piper Sandler and HC Wainwright & Co. raising their targets, showcasing market optimism regarding its future performance.
- Market Performance: ImmunityBio's stock has surged 184.54% over the past 12 months and is currently positioned closer to its 52-week highs, with a strong momentum score from Benzinga Edge indicating that the stock is outperforming the broader market, prompting investors to closely monitor upcoming earnings reports.
See More
ImmunityBio Resubmits Anktiva Application to FDA
- Application Resubmission: ImmunityBio Inc. announced on Monday that it has resubmitted its supplemental biologics license application for Anktiva to the FDA, including additional information requested to support its application for papillary disease, demonstrating the company's proactive approach in the drug approval process.
- Market Reaction: ImmunityBio's shares fell over 5% in pre-market trading on Monday, reflecting investor concerns about the company's future prospects, particularly amid increasing uncertainty surrounding FDA approvals.
- Investor Sentiment: Retail sentiment on Stocktwits indicated a bearish trend regarding ImmunityBio at the time of writing, which may further influence investor decisions and market performance, highlighting a lack of confidence in the company's product.
- Future Developments: As the FDA reviews the resubmitted application, ImmunityBio must closely monitor market feedback and investor sentiment to adjust its strategy in future communications, ensuring its position in the competitive biopharmaceutical market.
See More
ImmunityBio Receives FDA Acknowledgment for ANKTIVA sBLA Submission
- FDA Acknowledgment: ImmunityBio's supplemental Biologics License Application (sBLA) for ANKTIVA® has been acknowledged by the FDA for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), indicating the company's ongoing advancements in cancer treatment.
- Long-term Data Support: The combination of ANKTIVA and BCG demonstrated a 12-month disease-free survival rate of 58.2% in high-risk NMIBC patients, with a 36-month disease-specific survival rate of 96.0%, establishing a solid foundation for future clinical applications.
- International Approval Dynamics: The Saudi Food and Drug Authority (SFDA) has approved ANKTIVA in combination with checkpoint inhibitors for patients with metastatic non-small cell lung cancer who have progressed after standard therapies, showcasing the drug's potential in the global market.
- Clinical Data Presentation Plans: ImmunityBio plans to present clinical data supporting the SFDA approval, indicating that the median overall survival with ANKTIVA plus checkpoint inhibitors is nearly double that of traditional chemotherapy, further emphasizing its significance in cancer treatment.
See More
ImmunityBio Submits Supplemental BLA for Papillary Disease
- FDA Acknowledgment: ImmunityBio announced in March 2026 that the FDA has acknowledged receipt of its supplemental Biologics License Application (sBLA) for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), marking a significant step in addressing unmet patient needs.
- Clinical Data Support: The sBLA submission is backed by long-term results from the QUILT 3.032 trial, which demonstrated a 12-month disease-free survival rate of 58.2% in 80 high-risk patients, providing robust evidence for the efficacy of ANKTIVA combined with BCG.
- Significant Market Potential: Approximately 60,000 people are diagnosed with NMIBC annually in the U.S., with about 70% presenting with papillary (Ta) disease, indicating a substantial market opportunity for ImmunityBio's treatment to meet the urgent demand for effective therapies.
- International Expansion Plans: Following FDA approval, ImmunityBio intends to continue discussions with global regulatory authorities regarding the potential applications of ANKTIVA in other indications, further expanding its market share in cancer immunotherapy.
See More
ImmunityBio Advances Global NK Cell Bank Initiative
- NK Cell Production Data: Soon-Shiong highlighted upcoming data on large-scale production and cryopreservation of billions of natural killer (NK) cells, aiming to rekindle investor interest despite IBRX shares facing over 5% decline over six consecutive sessions.
- FDA Resubmission: ImmunityBio resubmitted its FDA application on Monday to expand Anktiva's use for early bladder cancer patients unresponsive to BCG therapy, with the updated filing including long-term follow-up results showing 58.2% of patients remained cancer-free after 12 months.
- AI Robot for Production: The company plans to utilize an AI-driven robot named Leonardo to automate NK cell production, aiming to store trillions of NK cells and develop CAR-NK cell therapies for global off-the-shelf treatment options.
- Market Sentiment Analysis: Despite IBRX stock surging over 300% year-to-date, retail sentiment on Stocktwits remains bearish, indicating concerns about the long-term outlook for the company amidst low message volume.
See More
Analysis of the Appeal of Heavily Shorted Stocks
- Short Interest Analysis: Many traders focus on heavily shorted stocks as they are perceived to carry potential downside risks, particularly when companies face challenges like disappointing earnings and persistent cash burn, which could lead to stock price declines.
- Short Squeeze Mechanics: A short squeeze is a rapid, feedback-driven price increase often triggered by unexpected positive catalysts, such as stronger-than-expected earnings or improved guidance, forcing short sellers to cover their positions, which further drives up the stock price.
- Characteristics of Heavily Shorted Stocks: Heavily shorted stocks typically belong to companies with market caps above $2 billion, average 14-day trading volumes exceeding 5 million shares, and free floats above 5 million shares, attracting significant attention from professional traders due to high short interest.
- Market Dynamics Impact: High short interest not only draws the attention of institutional investors but also piques the interest of retail and momentum traders, who believe that once the stock begins to rebound, short sellers will be forced to cover, accelerating the stock price increase.
See More
ImmunityBio Resubmits ANKTIVA Application to FDA Amid Stock Fluctuations
- FDA Resubmission: ImmunityBio has announced the resubmission of its supplemental Biologics License Application for ANKTIVA to the FDA, aimed at treating BCG-unresponsive non-muscle invasive bladder cancer, reflecting the company's proactive response to regulatory requirements during ongoing discussions with the agency.
- Stock Dynamics: ImmunityBio's shares are currently priced at $8.53, trading 1.3% below the 20-day simple moving average but 41.3% above the 100-day moving average, indicating a strong long-term trend despite facing some selling pressure in the short term.
- Analyst Ratings: The stock carries a Buy rating with an average price target of $12.50, with Piper Sandler and HC Wainwright & Co. raising their targets, showcasing market optimism regarding its future performance.
- Market Performance: ImmunityBio's stock has surged 184.54% over the past 12 months and is currently positioned closer to its 52-week highs, with a strong momentum score from Benzinga Edge indicating that the stock is outperforming the broader market, prompting investors to closely monitor upcoming earnings reports.
See More
ImmunityBio Resubmits Anktiva Application to FDA
- Application Resubmission: ImmunityBio Inc. announced on Monday that it has resubmitted its supplemental biologics license application for Anktiva to the FDA, including additional information requested to support its application for papillary disease, demonstrating the company's proactive approach in the drug approval process.
- Market Reaction: ImmunityBio's shares fell over 5% in pre-market trading on Monday, reflecting investor concerns about the company's future prospects, particularly amid increasing uncertainty surrounding FDA approvals.
- Investor Sentiment: Retail sentiment on Stocktwits indicated a bearish trend regarding ImmunityBio at the time of writing, which may further influence investor decisions and market performance, highlighting a lack of confidence in the company's product.
- Future Developments: As the FDA reviews the resubmitted application, ImmunityBio must closely monitor market feedback and investor sentiment to adjust its strategy in future communications, ensuring its position in the competitive biopharmaceutical market.
See More
ImmunityBio Receives FDA Acknowledgment for ANKTIVA sBLA Submission
- FDA Acknowledgment: ImmunityBio's supplemental Biologics License Application (sBLA) for ANKTIVA® has been acknowledged by the FDA for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), indicating the company's ongoing advancements in cancer treatment.
- Long-term Data Support: The combination of ANKTIVA and BCG demonstrated a 12-month disease-free survival rate of 58.2% in high-risk NMIBC patients, with a 36-month disease-specific survival rate of 96.0%, establishing a solid foundation for future clinical applications.
- International Approval Dynamics: The Saudi Food and Drug Authority (SFDA) has approved ANKTIVA in combination with checkpoint inhibitors for patients with metastatic non-small cell lung cancer who have progressed after standard therapies, showcasing the drug's potential in the global market.
- Clinical Data Presentation Plans: ImmunityBio plans to present clinical data supporting the SFDA approval, indicating that the median overall survival with ANKTIVA plus checkpoint inhibitors is nearly double that of traditional chemotherapy, further emphasizing its significance in cancer treatment.
See More
ImmunityBio Submits Supplemental BLA for Papillary Disease
- FDA Acknowledgment: ImmunityBio announced in March 2026 that the FDA has acknowledged receipt of its supplemental Biologics License Application (sBLA) for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), marking a significant step in addressing unmet patient needs.
- Clinical Data Support: The sBLA submission is backed by long-term results from the QUILT 3.032 trial, which demonstrated a 12-month disease-free survival rate of 58.2% in 80 high-risk patients, providing robust evidence for the efficacy of ANKTIVA combined with BCG.
- Significant Market Potential: Approximately 60,000 people are diagnosed with NMIBC annually in the U.S., with about 70% presenting with papillary (Ta) disease, indicating a substantial market opportunity for ImmunityBio's treatment to meet the urgent demand for effective therapies.
- International Expansion Plans: Following FDA approval, ImmunityBio intends to continue discussions with global regulatory authorities regarding the potential applications of ANKTIVA in other indications, further expanding its market share in cancer immunotherapy.
See More
