FDA Fast-Track Approvals for Two Cancer Drugs
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 days ago
0mins
Should l Buy IBRX?
Source: stocktwits
- FDA Fast-Tracking: The FDA approved Zongertinib for non-small cell lung cancer just 44 days after submission, with patient response rates soaring from 35% to 76%, indicating a potential shift in market dynamics and treatment standards.
- New Myeloma Therapy: Tec-Dara received approval 55 days post-filing, with clinical data showing an 83% reduction in disease progression or death risk, combining Tecvayli and Darzalex, which could disrupt existing treatment protocols in the multiple myeloma market.
- Market Reaction Fluctuations: IBRX shares fell 0.4% to $8.96 on Thursday, marking a third consecutive decline, yet the stock remains up over 350% this year, reflecting investor focus on new drug approvals and market sentiment volatility.
- Regulatory Bias Controversy: Retail investors criticized the FDA's rapid approvals as favoring big pharma, leading to a shift in sentiment from 'extremely bullish' to 'bearish', highlighting concerns over regulatory fairness and transparency.
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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: 8.450
Low
5.00
Averages
7.33
High
9.00
Current: 8.450
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 to Submit IL-15 Therapy Data Soon
- Upcoming Data Submission: Founder Patrick Soon-Shiong announced that new data related to the company's IL-15 cancer immunotherapy platform will soon be submitted to regulators, aiming to advance Anktiva's clinical application, despite shares dropping over 3% following this announcement.
- Mechanism Recognition: Soon-Shiong noted that institutions like the National Cancer Institute and NIH have recognized IL-15's potential to stimulate immune responses against tumors since 2007, with this mechanism being viewed as a 'game changer' in cancer treatment, potentially accelerating patient access to Anktiva.
- FDA Review Acceleration: As the FDA signals a push to expedite reviews for certain therapies, Soon-Shiong hopes FDA Commissioner Makary will closely review the upcoming data, which could provide a faster pathway for drug approval, particularly for patients with BCG-unresponsive bladder cancer.
- Market Sentiment Decline: Despite ImmunityBio's Anktiva therapy surging over 330% year-to-date, retail sentiment on Stocktwits has turned 'bearish', with a 67% drop in message volume, indicating a cautious outlook among investors regarding future developments.
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 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
FDA Fast-Track Approvals for Two Cancer Drugs
- FDA Fast-Tracking: The FDA approved Zongertinib for non-small cell lung cancer just 44 days after submission, with patient response rates soaring from 35% to 76%, indicating a potential shift in market dynamics and treatment standards.
- New Myeloma Therapy: Tec-Dara received approval 55 days post-filing, with clinical data showing an 83% reduction in disease progression or death risk, combining Tecvayli and Darzalex, which could disrupt existing treatment protocols in the multiple myeloma market.
- Market Reaction Fluctuations: IBRX shares fell 0.4% to $8.96 on Thursday, marking a third consecutive decline, yet the stock remains up over 350% this year, reflecting investor focus on new drug approvals and market sentiment volatility.
- Regulatory Bias Controversy: Retail investors criticized the FDA's rapid approvals as favoring big pharma, leading to a shift in sentiment from 'extremely bullish' to 'bearish', highlighting concerns over regulatory fairness and transparency.
See More
ImmunityBio to Submit IL-15 Therapy Data Soon
- Upcoming Data Submission: Founder Patrick Soon-Shiong announced that new data related to the company's IL-15 cancer immunotherapy platform will soon be submitted to regulators, aiming to advance Anktiva's clinical application, despite shares dropping over 3% following this announcement.
- Mechanism Recognition: Soon-Shiong noted that institutions like the National Cancer Institute and NIH have recognized IL-15's potential to stimulate immune responses against tumors since 2007, with this mechanism being viewed as a 'game changer' in cancer treatment, potentially accelerating patient access to Anktiva.
- FDA Review Acceleration: As the FDA signals a push to expedite reviews for certain therapies, Soon-Shiong hopes FDA Commissioner Makary will closely review the upcoming data, which could provide a faster pathway for drug approval, particularly for patients with BCG-unresponsive bladder cancer.
- Market Sentiment Decline: Despite ImmunityBio's Anktiva therapy surging over 330% year-to-date, retail sentiment on Stocktwits has turned 'bearish', with a 67% drop in message volume, indicating a cautious outlook among investors regarding future developments.
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 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
FDA Fast-Track Approvals for Two Cancer Drugs
- FDA Fast-Tracking: The FDA approved Zongertinib for non-small cell lung cancer just 44 days after submission, with patient response rates soaring from 35% to 76%, indicating a potential shift in market dynamics and treatment standards.
- New Myeloma Therapy: Tec-Dara received approval 55 days post-filing, with clinical data showing an 83% reduction in disease progression or death risk, combining Tecvayli and Darzalex, which could disrupt existing treatment protocols in the multiple myeloma market.
- Market Reaction Fluctuations: IBRX shares fell 0.4% to $8.96 on Thursday, marking a third consecutive decline, yet the stock remains up over 350% this year, reflecting investor focus on new drug approvals and market sentiment volatility.
- Regulatory Bias Controversy: Retail investors criticized the FDA's rapid approvals as favoring big pharma, leading to a shift in sentiment from 'extremely bullish' to 'bearish', highlighting concerns over regulatory fairness and transparency.
See More
