Anktiva Receives Conditional Approval Recommendation in EU
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
0mins
Should l Buy IBRX?
Source: stocktwits
- EU Approval Progress: In December 2025, the European Medicines Agency (EMA) recommended a conditional marketing authorization for Anktiva in combination with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), facilitating early access to a medicine that addresses an unmet medical need.
- FDA Resubmission Plans: ImmunityBio is eyeing the resubmission of its application for Anktiva in BCG-unresponsive NMIBC with papillary tumors, despite a previous refuse to file letter from the FDA, indicating ongoing efforts to advance the drug's market entry.
- Positive Market Reaction: ImmunityBio (IBRX) shares have gained 79% over the past 12 months, and while retail sentiment on Stocktwits remains bearish, investors are showing strong interest in the potential approval of Anktiva, with expectations for a decision as early as next Monday.
- Investor Confidence Boosted: Some investors have increased their holdings in IBRX after seeing a price dip, believing that Anktiva's approval will lead to significant stock price appreciation, reflecting market optimism about the drug's prospects and ImmunityBio's future growth.
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 rise
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 6.620
Low
5.00
Averages
7.33
High
9.00
Current: 6.620
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.
Anktiva Receives Conditional Approval Recommendation in EU
- EU Approval Progress: In December 2025, the European Medicines Agency (EMA) recommended a conditional marketing authorization for Anktiva in combination with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), facilitating early access to a medicine that addresses an unmet medical need.
- FDA Resubmission Plans: ImmunityBio is eyeing the resubmission of its application for Anktiva in BCG-unresponsive NMIBC with papillary tumors, despite a previous refuse to file letter from the FDA, indicating ongoing efforts to advance the drug's market entry.
- Positive Market Reaction: ImmunityBio (IBRX) shares have gained 79% over the past 12 months, and while retail sentiment on Stocktwits remains bearish, investors are showing strong interest in the potential approval of Anktiva, with expectations for a decision as early as next Monday.
- Investor Confidence Boosted: Some investors have increased their holdings in IBRX after seeing a price dip, believing that Anktiva's approval will lead to significant stock price appreciation, reflecting market optimism about the drug's prospects and ImmunityBio's future growth.
See More
Market Dynamics of Heavily Shorted Stocks
- Attraction of Shorted Stocks: LCID stock has become a target for heavy shorting as many experienced traders and institutional investors believe the company's fundamentals are overvalued, reflecting a pessimistic outlook on its future performance.
- Short Selling Mechanics: Short sellers bet on significant risks facing the company, such as poor earnings or industry headwinds, which may lead to a decline in stock price, thus garnering attention for short-selling strategies in the market.
- Short Squeeze Dynamics: When a stock's price unexpectedly rises, short sellers are forced to buy back shares to cover their positions, creating a surge in demand that further drives up the price, resulting in a feedback loop that can lead to explosive gains in a short time frame.
- Most Shorted Stocks List: As of February 13, the most heavily shorted stocks include companies with market caps above $2 billion and free floats exceeding 5 million shares, with short interest serving as a barometer of market sentiment.
See More
Pomerantz LLP Investigates ImmunityBio for Securities Fraud
- Securities Fraud Investigation: Pomerantz LLP is investigating whether ImmunityBio and its executives have engaged in securities fraud or other unlawful business practices, which could undermine investor confidence and lead to stock price volatility.
- Clinical Trial Results Underwhelming: On January 23, 2026, ImmunityBio announced that the primary endpoint of its immunotherapy trial for recurrent glioblastoma, the median overall survival, has not yet been reached, potentially impacting its future market performance.
- Significant Stock Price Drop: Following the release of unfavorable news, ImmunityBio's stock price fell by $0.89, a decline of 12.13%, closing at $6.45 per share, reflecting market disappointment regarding its clinical results.
- Law Firm Background: Pomerantz LLP is a prominent law firm specializing in securities and antitrust class litigation, with over 85 years of history advocating for the rights of victims of securities fraud, potentially providing legal support for affected investors.
See More
Immunitybio Launches Mid-Stage Clinical Study for iNHL
- Mid-Stage Study Launch: Immunitybio announced the initiation of a mid-stage clinical study targeting indolent B-cell non-Hodgkin lymphoma (iNHL), evaluating the combination of CD19 CAR-NK cell therapy with Anktiva and Rituximab without the need for traditional lymphodepleting chemotherapy, thereby offering a safer treatment option for patients.
- Recruitment of Refractory Patients: The study will enroll patients with Waldenström's Macroglobulinemia who have relapsed or are refractory after at least two prior lines of therapy, aiming to enhance the depth and durability of anti-tumor activity through further stimulation of innate and adaptive immune responses, showcasing the company's innovative potential in treating difficult-to-treat tumors.
- FDA Application Progress: Immunitybio recently met with the U.S. FDA to discuss its application for Anktiva in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer, which was rejected in 2025; however, the company plans to submit additional information within 30 days to support a resubmission, demonstrating its ongoing commitment to the market.
- Positive Market Reaction: On Stocktwits, retail sentiment around IBRX shares remains in the 'bullish' territory with high message volume, and IBRX stock has gained approximately 90% over the past 12 months, reflecting investor confidence in the company's future developments.
See More
Market Analysis of Heavily Shorted Stocks
- Attraction of Shorted Stocks: Investors maintain high short interest in overvalued stocks, indicating significant perceived risks such as poor earnings or industry headwinds that could drive prices down, impacting market sentiment and investment strategies.
- Bear vs. Bull Dynamics: Short sellers meticulously identify companies they view as ticking time bombs, while retail traders see high short interest as a potential springboard for price rebounds, where rising stock prices can trigger short squeezes, affecting market liquidity.
- Understanding Short Squeeze Mechanics: A short squeeze creates a volatile feedback loop initiated by unexpected price increases, forcing short sellers to buy back shares to cover positions, which spikes demand and further elevates prices, trapping more short sellers and potentially leading to outsized returns.
- Current Market Landscape: As of February 2, the most shorted stocks include those with market caps above $2 billion and free floats exceeding 5 million shares, ranked by short interest, highlighting the market's focus on these stocks and their associated risks.
See More
ImmunityBio Launches Phase 2 Study of CAR-NK Cell Therapy for iNHL
- Study Launch: ImmunityBio has announced the initiation of the ResQ215B study, evaluating a novel chemotherapy-free and lymphodepletion-free CAR-NK cell therapy aimed at treating indolent B-cell non-Hodgkin lymphoma (iNHL), including Waldenström’s Macroglobulinemia, marking a significant advancement in immunotherapy.
- Positive Clinical Results: In the Phase 1 study, all four patients with Waldenström’s Macroglobulinemia achieved clinical disease control when treated with CD19 CAR-NK cells combined with rituximab, with two patients maintaining complete remission at 7 and 15 months follow-up, indicating the therapy's potential.
- Significant Therapy Advantages: The design of the ResQ215B study eliminates the need for lymphodepleting chemotherapy, offering a safer treatment option that could transform the current treatment paradigm for indolent B-cell malignancies, particularly for patients deemed incurable.
- Enhanced Immune Response: By incorporating ANKTIVA, the study aims to further stimulate NK and CD8 T-cell activity, enhancing anti-tumor efficacy and potentially overcoming tumor resistance to rituximab, thereby improving the depth and durability of treatment responses.
See More
Anktiva Receives Conditional Approval Recommendation in EU
- EU Approval Progress: In December 2025, the European Medicines Agency (EMA) recommended a conditional marketing authorization for Anktiva in combination with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), facilitating early access to a medicine that addresses an unmet medical need.
- FDA Resubmission Plans: ImmunityBio is eyeing the resubmission of its application for Anktiva in BCG-unresponsive NMIBC with papillary tumors, despite a previous refuse to file letter from the FDA, indicating ongoing efforts to advance the drug's market entry.
- Positive Market Reaction: ImmunityBio (IBRX) shares have gained 79% over the past 12 months, and while retail sentiment on Stocktwits remains bearish, investors are showing strong interest in the potential approval of Anktiva, with expectations for a decision as early as next Monday.
- Investor Confidence Boosted: Some investors have increased their holdings in IBRX after seeing a price dip, believing that Anktiva's approval will lead to significant stock price appreciation, reflecting market optimism about the drug's prospects and ImmunityBio's future growth.
See More
Market Dynamics of Heavily Shorted Stocks
- Attraction of Shorted Stocks: LCID stock has become a target for heavy shorting as many experienced traders and institutional investors believe the company's fundamentals are overvalued, reflecting a pessimistic outlook on its future performance.
- Short Selling Mechanics: Short sellers bet on significant risks facing the company, such as poor earnings or industry headwinds, which may lead to a decline in stock price, thus garnering attention for short-selling strategies in the market.
- Short Squeeze Dynamics: When a stock's price unexpectedly rises, short sellers are forced to buy back shares to cover their positions, creating a surge in demand that further drives up the price, resulting in a feedback loop that can lead to explosive gains in a short time frame.
- Most Shorted Stocks List: As of February 13, the most heavily shorted stocks include companies with market caps above $2 billion and free floats exceeding 5 million shares, with short interest serving as a barometer of market sentiment.
See More
Pomerantz LLP Investigates ImmunityBio for Securities Fraud
- Securities Fraud Investigation: Pomerantz LLP is investigating whether ImmunityBio and its executives have engaged in securities fraud or other unlawful business practices, which could undermine investor confidence and lead to stock price volatility.
- Clinical Trial Results Underwhelming: On January 23, 2026, ImmunityBio announced that the primary endpoint of its immunotherapy trial for recurrent glioblastoma, the median overall survival, has not yet been reached, potentially impacting its future market performance.
- Significant Stock Price Drop: Following the release of unfavorable news, ImmunityBio's stock price fell by $0.89, a decline of 12.13%, closing at $6.45 per share, reflecting market disappointment regarding its clinical results.
- Law Firm Background: Pomerantz LLP is a prominent law firm specializing in securities and antitrust class litigation, with over 85 years of history advocating for the rights of victims of securities fraud, potentially providing legal support for affected investors.
See More
Immunitybio Launches Mid-Stage Clinical Study for iNHL
- Mid-Stage Study Launch: Immunitybio announced the initiation of a mid-stage clinical study targeting indolent B-cell non-Hodgkin lymphoma (iNHL), evaluating the combination of CD19 CAR-NK cell therapy with Anktiva and Rituximab without the need for traditional lymphodepleting chemotherapy, thereby offering a safer treatment option for patients.
- Recruitment of Refractory Patients: The study will enroll patients with Waldenström's Macroglobulinemia who have relapsed or are refractory after at least two prior lines of therapy, aiming to enhance the depth and durability of anti-tumor activity through further stimulation of innate and adaptive immune responses, showcasing the company's innovative potential in treating difficult-to-treat tumors.
- FDA Application Progress: Immunitybio recently met with the U.S. FDA to discuss its application for Anktiva in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer, which was rejected in 2025; however, the company plans to submit additional information within 30 days to support a resubmission, demonstrating its ongoing commitment to the market.
- Positive Market Reaction: On Stocktwits, retail sentiment around IBRX shares remains in the 'bullish' territory with high message volume, and IBRX stock has gained approximately 90% over the past 12 months, reflecting investor confidence in the company's future developments.
See More
Market Analysis of Heavily Shorted Stocks
- Attraction of Shorted Stocks: Investors maintain high short interest in overvalued stocks, indicating significant perceived risks such as poor earnings or industry headwinds that could drive prices down, impacting market sentiment and investment strategies.
- Bear vs. Bull Dynamics: Short sellers meticulously identify companies they view as ticking time bombs, while retail traders see high short interest as a potential springboard for price rebounds, where rising stock prices can trigger short squeezes, affecting market liquidity.
- Understanding Short Squeeze Mechanics: A short squeeze creates a volatile feedback loop initiated by unexpected price increases, forcing short sellers to buy back shares to cover positions, which spikes demand and further elevates prices, trapping more short sellers and potentially leading to outsized returns.
- Current Market Landscape: As of February 2, the most shorted stocks include those with market caps above $2 billion and free floats exceeding 5 million shares, ranked by short interest, highlighting the market's focus on these stocks and their associated risks.
See More
ImmunityBio Launches Phase 2 Study of CAR-NK Cell Therapy for iNHL
- Study Launch: ImmunityBio has announced the initiation of the ResQ215B study, evaluating a novel chemotherapy-free and lymphodepletion-free CAR-NK cell therapy aimed at treating indolent B-cell non-Hodgkin lymphoma (iNHL), including Waldenström’s Macroglobulinemia, marking a significant advancement in immunotherapy.
- Positive Clinical Results: In the Phase 1 study, all four patients with Waldenström’s Macroglobulinemia achieved clinical disease control when treated with CD19 CAR-NK cells combined with rituximab, with two patients maintaining complete remission at 7 and 15 months follow-up, indicating the therapy's potential.
- Significant Therapy Advantages: The design of the ResQ215B study eliminates the need for lymphodepleting chemotherapy, offering a safer treatment option that could transform the current treatment paradigm for indolent B-cell malignancies, particularly for patients deemed incurable.
- Enhanced Immune Response: By incorporating ANKTIVA, the study aims to further stimulate NK and CD8 T-cell activity, enhancing anti-tumor efficacy and potentially overcoming tumor resistance to rituximab, thereby improving the depth and durability of treatment responses.
See More
