ImmunityBio Secures EU Approval for Bladder Cancer Therapy
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 20 hours ago
0mins
Should l Buy IBRX?
Source: seekingalpha
- Market Authorization Expansion: ImmunityBio (IBRX) saw its stock rise on Wednesday following the European Commission's conditional marketing authorization for its bladder cancer therapy Anktiva, expanding its use across 27 countries and significantly enhancing the company's competitive position in the European market.
- Expert Panel Support: This decision came after an expert panel from the EU drug regulator endorsed the immunotherapy in December as part of a combination regimen for invasive bladder cancer, indicating strong recognition of Anktiva's efficacy.
- Clinical Trial Basis: The authorization was based on IBRX's Phase 2/3 QUILT-3.032 study, demonstrating the effectiveness of Anktiva in combination with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer, further solidifying its clinical standing.
- Long-term Data Requirement: As part of the conditional approval, ImmunityBio is required to provide EU regulators with long-term safety and efficacy data related to Anktiva, which not only tests the company's R&D capabilities but may also impact its future market performance.
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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: 6.020
Low
5.00
Averages
7.33
High
9.00
Current: 6.020
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 Secures Conditional EU Authorization for Anktiva
- Conditional EU Authorization: ImmunityBio's Anktiva has received conditional marketing authorization from the European Commission, allowing sales across 27 EU member states, Iceland, Liechtenstein, and Norway, marking a significant expansion in the global market.
- Safety and Efficacy Data Submission: The company will submit long-term safety and efficacy data to the European Medicines Agency to meet regulatory requirements and facilitate the widespread use of Anktiva in Europe, addressing the treatment gap for BCG-unresponsive NMIBC CIS patients.
- Positive Market Reaction: Following the authorization, ImmunityBio's stock surged 30% on Wednesday, reflecting strong market demand for the new therapy and investor optimism, indicating the company's potential in treating BCG-unresponsive bladder cancer.
- Global Approval Progress: Anktiva is now approved in 33 countries, including the U.S., showcasing the company's regulatory success within just two years, with CEO Richard Adcock highlighting the strength of clinical evidence and the urgency of unmet market needs.
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- Record Short Interest: Between February 13 and 19, ImmunityBio's short interest surged to 13.7% of free float, marking an all-time high and increasing from 12.9% in the previous period, indicating heightened investor anxiety ahead of the European Commission's decision on Anktiva.
- Retail Sentiment Shift: During the same timeframe, retail traders flipped from 'bearish' to 'bullish', with Stocktwits message volume jumping over 300%, reflecting optimism about potential European approval and suggesting that short sellers could be caught off guard.
- Surge in Options Activity: On February 18, over 30,000 call options were traded for ImmunityBio, nearly double the normal volume, while implied volatility rose to around 129%, indicating strong market expectations for the company's future performance following the anticipated regulatory decision.
- EU Approval Boosts Stock Price: Following the European Commission's conditional marketing authorization, ImmunityBio's shares soared 42%, expanding Anktiva's availability to 33 countries, which signifies a major breakthrough for the company in the cancer treatment landscape.
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ImmunityBio Stock Soars After EU Authorization for Anktiva
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- Volume Spike: Trading volume reached 78.5 million shares, approximately 178% above the three-month average, indicating robust investor interest in ImmunityBio's growth potential, which may attract more institutional investors.
- Market Expansion Opportunity: With EU authorization, ImmunityBio's Anktiva will enter over 30 new countries, likely accelerating sales growth and further solidifying its market position in cancer treatment.
- Remarkable Sales Growth: ImmunityBio achieved over 700% sales growth for Anktiva in 2025 and received approval from the Saudi Food and Drug Authority, showcasing its product's broad application potential in cancer treatment, although the company remains subject to market volatility risks.
See More
ImmunityBio Stock Soars After EU Grants Conditional Approval for Anktiva
- Significant Stock Surge: ImmunityBio's stock closed at $8.54 on Wednesday, reflecting a 41.86% increase, primarily driven by the European Commission's conditional marketing authorization for Anktiva to treat bladder cancer, which significantly boosted market confidence.
- Surge in Trading Volume: The trading volume reached 78.5 million shares, approximately 178% above the three-month average of 28.2 million shares, indicating strong investor interest and engagement regarding the company's future prospects.
- Market Expansion Opportunities: The EU authorization allows ImmunityBio to access over 30 new countries, likely accelerating sales growth for its flagship immunotherapy and further solidifying its market position in the biotechnology sector.
- Investment Risk Advisory: Although Anktiva shows promising treatment potential, ImmunityBio's stock remains volatile, and investors should exercise caution, particularly given the company's dependence on positive news regarding its main immunotherapy.
See More
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- Stock Surge: ImmunityBio's shares soared by 33.1% on Wednesday, reaching $8.29 per share, reflecting strong investor optimism following the approval of its drug Anktiva, indicating confidence in the company's future growth prospects.
- Drug Approval: The combination treatment of Anktiva and BCG vaccine received approval from the EU regulatory commission for non-muscle invasive bladder cancer in 30 countries, which will further expand its market reach and enhance sales potential.
- Revenue Expectations: Despite Anktiva being on the U.S. market for less than two years, the company anticipates $113 million in revenue for the fiscal year ending in December, with a projected 20% quarter-over-quarter growth in the final quarter of 2025, indicating strong demand in new markets.
- Market Outlook: With a market cap of under $8 billion, ImmunityBio operates in a global oncology market projected to grow from $350 billion last year to $860 billion by 2034, and the cancer immunotherapy segment alone expected to reach $277 billion by 2032, capturing even a fraction of this growth could yield significant returns for the company.
See More
ImmunityBio Secures Conditional EU Authorization for Anktiva
- Conditional EU Authorization: ImmunityBio's Anktiva has received conditional marketing authorization from the European Commission, allowing sales across 27 EU member states, Iceland, Liechtenstein, and Norway, marking a significant expansion in the global market.
- Safety and Efficacy Data Submission: The company will submit long-term safety and efficacy data to the European Medicines Agency to meet regulatory requirements and facilitate the widespread use of Anktiva in Europe, addressing the treatment gap for BCG-unresponsive NMIBC CIS patients.
- Positive Market Reaction: Following the authorization, ImmunityBio's stock surged 30% on Wednesday, reflecting strong market demand for the new therapy and investor optimism, indicating the company's potential in treating BCG-unresponsive bladder cancer.
- Global Approval Progress: Anktiva is now approved in 33 countries, including the U.S., showcasing the company's regulatory success within just two years, with CEO Richard Adcock highlighting the strength of clinical evidence and the urgency of unmet market needs.
See More
Investors Focus on Fed Minutes and Walmart Earnings
- Fed Minutes Analysis: The January FOMC minutes indicate broad support among policymakers for pausing rate cuts despite ongoing inflation risks, which could influence future monetary policy directions and affect market sentiment and investment decisions.
- Walmart Earnings Preview: Walmart is set to report earnings before the bell today, with investors keenly awaiting insights from the new CEO regarding consumer health and demand, which will directly impact retail sector performance and investor confidence.
- Meta Smartwatch Plans Revived: Reports suggest that Meta has revived its smartwatch plans targeting a launch this year, a strategic shift that could enhance its competitiveness in the wearables market and provide new revenue streams for the company.
- Economic Data and Market Reaction: Key economic indicators such as Initial Jobless Claims and the Philly Fed Business Index are scheduled for release today, with investors closely monitoring their impact on the market, especially amid heightened uncertainty regarding Fed policies.
See More
ImmunityBio's Short Interest Turns Bullish Ahead of EU Decision
- Record Short Interest: Between February 13 and 19, ImmunityBio's short interest surged to 13.7% of free float, marking an all-time high and increasing from 12.9% in the previous period, indicating heightened investor anxiety ahead of the European Commission's decision on Anktiva.
- Retail Sentiment Shift: During the same timeframe, retail traders flipped from 'bearish' to 'bullish', with Stocktwits message volume jumping over 300%, reflecting optimism about potential European approval and suggesting that short sellers could be caught off guard.
- Surge in Options Activity: On February 18, over 30,000 call options were traded for ImmunityBio, nearly double the normal volume, while implied volatility rose to around 129%, indicating strong market expectations for the company's future performance following the anticipated regulatory decision.
- EU Approval Boosts Stock Price: Following the European Commission's conditional marketing authorization, ImmunityBio's shares soared 42%, expanding Anktiva's availability to 33 countries, which signifies a major breakthrough for the company in the cancer treatment landscape.
See More
ImmunityBio Stock Soars After EU Authorization for Anktiva
- Significant Stock Surge: ImmunityBio's stock surged 41.36% to close at $8.54 following the European Commission's conditional marketing authorization for Anktiva, reflecting strong market confidence in its cancer immunotherapy.
- Volume Spike: Trading volume reached 78.5 million shares, approximately 178% above the three-month average, indicating robust investor interest in ImmunityBio's growth potential, which may attract more institutional investors.
- Market Expansion Opportunity: With EU authorization, ImmunityBio's Anktiva will enter over 30 new countries, likely accelerating sales growth and further solidifying its market position in cancer treatment.
- Remarkable Sales Growth: ImmunityBio achieved over 700% sales growth for Anktiva in 2025 and received approval from the Saudi Food and Drug Authority, showcasing its product's broad application potential in cancer treatment, although the company remains subject to market volatility risks.
See More
ImmunityBio Stock Soars After EU Grants Conditional Approval for Anktiva
- Significant Stock Surge: ImmunityBio's stock closed at $8.54 on Wednesday, reflecting a 41.86% increase, primarily driven by the European Commission's conditional marketing authorization for Anktiva to treat bladder cancer, which significantly boosted market confidence.
- Surge in Trading Volume: The trading volume reached 78.5 million shares, approximately 178% above the three-month average of 28.2 million shares, indicating strong investor interest and engagement regarding the company's future prospects.
- Market Expansion Opportunities: The EU authorization allows ImmunityBio to access over 30 new countries, likely accelerating sales growth for its flagship immunotherapy and further solidifying its market position in the biotechnology sector.
- Investment Risk Advisory: Although Anktiva shows promising treatment potential, ImmunityBio's stock remains volatile, and investors should exercise caution, particularly given the company's dependence on positive news regarding its main immunotherapy.
See More
ImmunityBio's Drug Approved in EU, Shares Surge
- Stock Surge: ImmunityBio's shares soared by 33.1% on Wednesday, reaching $8.29 per share, reflecting strong investor optimism following the approval of its drug Anktiva, indicating confidence in the company's future growth prospects.
- Drug Approval: The combination treatment of Anktiva and BCG vaccine received approval from the EU regulatory commission for non-muscle invasive bladder cancer in 30 countries, which will further expand its market reach and enhance sales potential.
- Revenue Expectations: Despite Anktiva being on the U.S. market for less than two years, the company anticipates $113 million in revenue for the fiscal year ending in December, with a projected 20% quarter-over-quarter growth in the final quarter of 2025, indicating strong demand in new markets.
- Market Outlook: With a market cap of under $8 billion, ImmunityBio operates in a global oncology market projected to grow from $350 billion last year to $860 billion by 2034, and the cancer immunotherapy segment alone expected to reach $277 billion by 2032, capturing even a fraction of this growth could yield significant returns for the company.
See More
