Agenus SEC Investigation Concluded, No Enforcement Action Needed
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 11 2026
0mins
The company said, "On May 4, 2026, the U.S. Securities and Exchange Commission informed Agenus that it has concluded its investigation as to the Company and does not intend to recommend an enforcement action. Separately, on March 24, 2026, the U.S. District Court for the District of Massachusetts granted Agenus's motion to dismiss the related putative securities class action in its entirety. The lead plaintiff has filed a Notice of Appeal to the U.S. Court of Appeals for the First Circuit. Additional information regarding both matters is included in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2026."
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Analyst Views on AGEN
Wall Street analysts forecast AGEN stock price to rise
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 3.400
Low
23.00
Averages
23.00
High
23.00
Current: 3.400
Low
23.00
Averages
23.00
High
23.00
About AGEN
Agenus Inc. is an immuno-oncology (I-O) company targeting cancer with a comprehensive pipeline of immunological agents. The company is focused on expanding patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Its I-O portfolio is driven by several platforms and programs, which include multiple antibody discovery platforms, antibody candidate programs, its saponin-based vaccine adjuvant platform, and a pipeline of novel allogeneic invariant natural killer T cell (iNKT) therapies for treating cancer and other immune-mediated diseases, controlled by MiNK. Its antibody candidate programs include botensilimab (BOT) and balstilimab (BAL) (a PD-1 blocking antibody). The Company has secured committed manufacturing capacity to support BOT+BAL supply needs for its clinical trials, global access programs and future commercialization.
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.
Noetik's TARIO-2 Platform Reveals Tumor Microenvironment Patterns
- Significant Clinical Response: Among 113 patients treated with BOT+BAL, the AI-identified subgroup exhibited a 64% response rate compared to just 9% in the remaining cohort, highlighting TARIO-2's potential in identifying patients likely to benefit from treatment.
- Improved Survival Rates: In the MSS metastatic colorectal cancer cohort without active liver metastases, the AI-identified subgroup had a median overall survival not reached, with a hazard ratio of 0.18, indicating TARIO-2's significant predictive power for survival outcomes.
- Innovative Technology Application: The TARIO-2 model analyzes standard H&E pathology images to extract biologically relevant tumor microenvironment features, offering a patient stratification strategy that does not rely on complex tissue profiling, which could transform clinical practices.
- Future Validation Plans: Agenus is set to present these findings at the 2026 ASCO Annual Meeting, aiming to validate TARIO-2 as an image-based biomarker strategy for BOT+BAL, thereby advancing the clinical development of immunotherapy.
See More
Agenus Reports New Data on HCC Treatment
- Clinical Trial Results: Agenus' Phase 1b trial data reveals that in 19 patients with treatment-refractory hepatocellular carcinoma (HCC), the combination of BOT and BAL achieved an objective response rate of 17%, including one complete response and two partial responses, indicating potential efficacy in this challenging patient population.
- Survival Analysis: Among 18 efficacy-evaluable patients, the median overall survival was reported at 12.3 months, despite 47% of the cohort having ALBI grade 2 liver function, which typically indicates poorer prognosis, thus highlighting the potential of BOT and BAL in improving survival outcomes.
- Safety Assessment: The safety profile of BOT and BAL in HCC patients was consistent with prior studies, with 68% of patients experiencing immune-mediated adverse events and no treatment-related deaths, suggesting that the combination is manageable and suitable for further investigation.
- Future Research Directions: Investigators noted that the BOT and BAL combination demonstrated promising efficacy and manageable safety in post-immunotherapy HCC patients, supporting continued exploration in this area to assess its applicability in a broader patient population.
See More
Agenus Scheduled to Announce Q1 Earnings on May 11
- Earnings Announcement Timing: Agenus (AGEN) is set to release its Q1 2023 earnings report on May 11 before the market opens, drawing significant attention from investors regarding its performance and future outlook.
- Earnings Expectations: The consensus EPS estimate stands at $2.10, with revenue expectations at $129.5 million, metrics that could directly influence investor confidence and market sentiment.
- Historical Performance Review: Over the past year, Agenus has only surpassed EPS and revenue estimates 25% of the time, indicating considerable volatility in its performance, which may affect market expectations for future results.
- Market Reaction Potential: Given Agenus's inconsistent performance in exceeding expectations, investors should closely monitor the upcoming earnings report to assess its potential impact on stock price and the necessity for strategic adjustments.
See More
Agenus Announces Q1 2026 Financial Results Release Schedule
- Financial Results Announcement: Agenus plans to release its Q1 2026 financial results before the market opens on May 11, 2026, which is expected to provide investors with the latest insights into the company's financial health, potentially impacting stock price movements.
- Annual Shareholder Meeting: The company will host a webcast in June in conjunction with its Annual Meeting of Shareholders, focusing on key strategic priorities and upcoming data milestones, aimed at enhancing investor confidence and attracting more attention.
- Clinical Trial Progress: Approximately 1,200 patients have been treated with botensilimab and balstilimab in phase 1 and phase 2 clinical trials, demonstrating clinical responses across nine metastatic late-line cancers, which may lay the groundwork for the company's future market performance.
- Development Capabilities: Agenus boasts a comprehensive pipeline of immuno-oncology agents and robust development capabilities, leveraging its clinical and commercial cGMP manufacturing facilities, which may position the company favorably in future market competition.
See More
New Therapy Shows Significant Efficacy in Gastroesophageal Cancer
- Significant Disease Control: A clinical trial for gastroesophageal cancer combining botensilimab (BOT), balstilimab (BAL), and agenT-797 demonstrated a 77% disease control rate, with long-term survival exceeding 20 months in a subset of heavily pretreated patients, indicating the potential of this combination therapy in refractory cases.
- Improved Survival Rates: Patients receiving induction therapy had a median progression-free survival (PFS) of 6.9 months compared to 3.5 months for those without induction, with a hazard ratio (HR) of 0.19 and a p-value of 0.015, underscoring the importance of immune activation and treatment sequencing.
- Enhanced Long-Term Survival: In the induction cohort, 43% of patients were alive at both 12 and 18 months, compared to only 20% and 0% in the non-induction group, highlighting the effectiveness of the induction strategy in improving long-term survival outcomes.
- Insights into Immune Mechanisms: The study revealed that the combination of BOT, BAL, and agenT-797 significantly promoted intratumoral T cell and dendritic cell infiltration, leading to the formation of organized tertiary lymphoid structures, providing crucial insights for further exploration of the biological basis of this therapy.
See More
Agenus Shows Remarkably Improving Earnings Outlook
- Earnings Estimate Revisions: Analysts have raised their earnings estimates for Agenus, projecting a quarterly EPS of $1.95, reflecting a remarkable 289.3% increase from the previous year, indicating a significant enhancement in the company's profitability that could drive further stock price appreciation.
- Zacks Rank Upgrade: Due to the positive revisions in earnings estimates, Agenus currently holds a Zacks Rank #1 (Strong Buy), a rating tool that has demonstrated an average annual return of 25% since 2008, showcasing strong investment potential.
- Full-Year Earnings Outlook: The full-year EPS estimate for Agenus stands at $1.30, representing a 151.8% increase from last year, with no negative revisions in the past month, reflecting strong analyst confidence in the company's future performance.
- Stock Price Uptrend: Over the past four weeks, Agenus's stock has risen by 14%, closely tied to the upward revisions in earnings estimates, suggesting that further upside potential remains, making it a candidate for investors to consider adding to their portfolios.
See More
Noetik's TARIO-2 Platform Reveals Tumor Microenvironment Patterns
- Significant Clinical Response: Among 113 patients treated with BOT+BAL, the AI-identified subgroup exhibited a 64% response rate compared to just 9% in the remaining cohort, highlighting TARIO-2's potential in identifying patients likely to benefit from treatment.
- Improved Survival Rates: In the MSS metastatic colorectal cancer cohort without active liver metastases, the AI-identified subgroup had a median overall survival not reached, with a hazard ratio of 0.18, indicating TARIO-2's significant predictive power for survival outcomes.
- Innovative Technology Application: The TARIO-2 model analyzes standard H&E pathology images to extract biologically relevant tumor microenvironment features, offering a patient stratification strategy that does not rely on complex tissue profiling, which could transform clinical practices.
- Future Validation Plans: Agenus is set to present these findings at the 2026 ASCO Annual Meeting, aiming to validate TARIO-2 as an image-based biomarker strategy for BOT+BAL, thereby advancing the clinical development of immunotherapy.
See More
Agenus Reports New Data on HCC Treatment
- Clinical Trial Results: Agenus' Phase 1b trial data reveals that in 19 patients with treatment-refractory hepatocellular carcinoma (HCC), the combination of BOT and BAL achieved an objective response rate of 17%, including one complete response and two partial responses, indicating potential efficacy in this challenging patient population.
- Survival Analysis: Among 18 efficacy-evaluable patients, the median overall survival was reported at 12.3 months, despite 47% of the cohort having ALBI grade 2 liver function, which typically indicates poorer prognosis, thus highlighting the potential of BOT and BAL in improving survival outcomes.
- Safety Assessment: The safety profile of BOT and BAL in HCC patients was consistent with prior studies, with 68% of patients experiencing immune-mediated adverse events and no treatment-related deaths, suggesting that the combination is manageable and suitable for further investigation.
- Future Research Directions: Investigators noted that the BOT and BAL combination demonstrated promising efficacy and manageable safety in post-immunotherapy HCC patients, supporting continued exploration in this area to assess its applicability in a broader patient population.
See More
Agenus Scheduled to Announce Q1 Earnings on May 11
- Earnings Announcement Timing: Agenus (AGEN) is set to release its Q1 2023 earnings report on May 11 before the market opens, drawing significant attention from investors regarding its performance and future outlook.
- Earnings Expectations: The consensus EPS estimate stands at $2.10, with revenue expectations at $129.5 million, metrics that could directly influence investor confidence and market sentiment.
- Historical Performance Review: Over the past year, Agenus has only surpassed EPS and revenue estimates 25% of the time, indicating considerable volatility in its performance, which may affect market expectations for future results.
- Market Reaction Potential: Given Agenus's inconsistent performance in exceeding expectations, investors should closely monitor the upcoming earnings report to assess its potential impact on stock price and the necessity for strategic adjustments.
See More
Agenus Announces Q1 2026 Financial Results Release Schedule
- Financial Results Announcement: Agenus plans to release its Q1 2026 financial results before the market opens on May 11, 2026, which is expected to provide investors with the latest insights into the company's financial health, potentially impacting stock price movements.
- Annual Shareholder Meeting: The company will host a webcast in June in conjunction with its Annual Meeting of Shareholders, focusing on key strategic priorities and upcoming data milestones, aimed at enhancing investor confidence and attracting more attention.
- Clinical Trial Progress: Approximately 1,200 patients have been treated with botensilimab and balstilimab in phase 1 and phase 2 clinical trials, demonstrating clinical responses across nine metastatic late-line cancers, which may lay the groundwork for the company's future market performance.
- Development Capabilities: Agenus boasts a comprehensive pipeline of immuno-oncology agents and robust development capabilities, leveraging its clinical and commercial cGMP manufacturing facilities, which may position the company favorably in future market competition.
See More
New Therapy Shows Significant Efficacy in Gastroesophageal Cancer
- Significant Disease Control: A clinical trial for gastroesophageal cancer combining botensilimab (BOT), balstilimab (BAL), and agenT-797 demonstrated a 77% disease control rate, with long-term survival exceeding 20 months in a subset of heavily pretreated patients, indicating the potential of this combination therapy in refractory cases.
- Improved Survival Rates: Patients receiving induction therapy had a median progression-free survival (PFS) of 6.9 months compared to 3.5 months for those without induction, with a hazard ratio (HR) of 0.19 and a p-value of 0.015, underscoring the importance of immune activation and treatment sequencing.
- Enhanced Long-Term Survival: In the induction cohort, 43% of patients were alive at both 12 and 18 months, compared to only 20% and 0% in the non-induction group, highlighting the effectiveness of the induction strategy in improving long-term survival outcomes.
- Insights into Immune Mechanisms: The study revealed that the combination of BOT, BAL, and agenT-797 significantly promoted intratumoral T cell and dendritic cell infiltration, leading to the formation of organized tertiary lymphoid structures, providing crucial insights for further exploration of the biological basis of this therapy.
See More
Agenus Shows Remarkably Improving Earnings Outlook
- Earnings Estimate Revisions: Analysts have raised their earnings estimates for Agenus, projecting a quarterly EPS of $1.95, reflecting a remarkable 289.3% increase from the previous year, indicating a significant enhancement in the company's profitability that could drive further stock price appreciation.
- Zacks Rank Upgrade: Due to the positive revisions in earnings estimates, Agenus currently holds a Zacks Rank #1 (Strong Buy), a rating tool that has demonstrated an average annual return of 25% since 2008, showcasing strong investment potential.
- Full-Year Earnings Outlook: The full-year EPS estimate for Agenus stands at $1.30, representing a 151.8% increase from last year, with no negative revisions in the past month, reflecting strong analyst confidence in the company's future performance.
- Stock Price Uptrend: Over the past four weeks, Agenus's stock has risen by 14%, closely tied to the upward revisions in earnings estimates, suggesting that further upside potential remains, making it a candidate for investors to consider adding to their portfolios.
See More
