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Agenus Inc. (NASDAQ: AGEN) generates a steady stream of news centered on its immuno-oncology pipeline, with particular focus on the botensilimab (BOT) and balstilimab (BAL) combination. As a Lexington, Massachusetts-based biological products manufacturer focused on cancer immunotherapy, the company’s updates frequently highlight progress in clinical trials, early-access frameworks and strategic collaborations.
Many recent headlines relate to BOT+BAL’s performance in advanced solid tumors. Agenus reports data from the C-800-01 Phase 1b trial, which evaluates the combination across multiple refractory cancers, and from the global BATTMAN CO.33 Phase 3 trial in microsatellite-stable colorectal cancer conducted with the Canadian Cancer Trials Group and international academic partners. News coverage also includes peer-reviewed publications, such as results in treatment-refractory ovarian cancer, and presentations at major oncology congresses.
Another major theme in Agenus news is patient access. The company has announced that France’s medicines agency authorized a national Autorisation d’Accès Compassionnel (AAC) protocol for BOT+BAL, enabling fully reimbursed hospital-based access for eligible patients with microsatellite-stable metastatic colorectal cancer, certain ovarian cancers and soft-tissue sarcomas. Additional stories describe named-patient and early-access programs in other geographies where regulations allow.
Strategic and corporate developments also feature prominently. Agenus has disclosed a collaboration with Zydus Lifesciences involving the sale of biologics manufacturing facilities in California, an equity investment in Agenus, and an exclusive license for BOT and BAL in India and Sri Lanka, along with the creation of Zylidac Bio LLC to house the acquired U.S. manufacturing assets. Investors following AGEN news can expect updates on clinical milestones, regulatory interactions, early-access expansions, manufacturing partnerships and periodic financial and corporate communications.
Agenus (Nasdaq: AGEN) reported Q3 2025 results and a business update highlighting clinical and regulatory progress for botensilimab plus balstilimab (BOT/BAL).
Key items: France authorized reimbursed compassionate access for BOT/BAL in refractory MSS mCRC without active liver metastases; Phase 3 BATTMAN global registrational trial launching Q4 2025 across 100+ sites; updated survival data showing 42% two‑year OS in 123 MSS mCRC patients and 39% two‑year OS across >400 pan‑tumor patients; a ~$100.9M gain from MiNK deconsolidation and a $10M bridge ahead of an anticipated $91M Zydus closing.
Agenus (Nasdaq: AGEN) said it will release its third quarter 2025 financial results before the market opens on Monday, November 10, 2025.
The company also plans a stakeholder briefing webcast in late November to provide a corporate and clinical development update; timing and access details will be announced in the coming weeks.
Agenus (Nasdaq: AGEN) reported updated clinical data for the botensilimab (BOT) plus balstilimab (BAL) combination from expansion cohorts of the Phase 1b C-800-01 study presented at ESMO 2025. Across 411 enrolled patients (339 evaluable), the pan-tumor dataset showed a 2-year overall survival (OS) of 39%, median OS of 17.2 months, and objective response rate (ORR) of 17%. Sixty-one percent received ≥3 prior lines of therapy. The combo was generally tolerable with reversible immune-related GI events and no treatment-related deaths. France granted compassionate access for BOT+BAL in refractory MSS mCRC.
Agenus (Nasdaq: AGEN) will host a virtual Stakeholder Briefing on Tuesday, October 21, 2025 at 4:00 p.m. ET to share post-ESMO clinical updates and global access progress for its immunotherapy combination botensilimab (BOT) and balstilimab (BAL).
Speakers include Michael S. Gordon, MD, discussing ESMO 2025 results from >400 patients treated with BOT/BAL across refractory solid tumors, and Alexander M.M. Eggermont, MD, PhD, on France’s AAC program and BOT/BAL inclusion. The session, moderated by Garo Armen, will end with live Q&A. No pre-registration is required and a webcast link is provided.
Agenus (NASDAQ: AGEN) has achieved a significant milestone as its investigational combination therapy botensilimab plus balstilimab (BOT/BAL) receives reimbursed compassionate access in France for treating refractory microsatellite-stable (MSS) metastatic colorectal cancer (mCRC).
The treatment will be available through France's Accès compassionnel (AAC) framework, with 100% coverage by Assurance Maladie for eligible patients. Clinical data shows promising results, including ~21-month median overall survival, ~42% 2-year survival, and ~20% objective response rate in expanded cohorts.
The AAC authorization enables hospital use with full reimbursement at the invoiced purchase price, outside the Diagnosis-related Group. EU/EEA patients may access the treatment in France under specific directives, while non-EU countries like Turkey can participate through treatment-abroad programs.
Agenus (NASDAQ:AGEN), an immuno-oncology company, will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York City.
The company's executives, Dr. Richard Goldberg (Chief Development Officer) and Dr. Robin Taylor (Chief Commercial Officer), will conduct a fireside chat on September 9, 2025, from 10:00-10:30 AM EST. They will discuss the BOT/BAL immunotherapy program, including updates on the pivotal Phase 3 BATTMAN trial in metastatic colorectal cancer, clinical data, partnerships, and upcoming milestones for H2 2025.
Agenus (Nasdaq: AGEN), a leader in immuno-oncology, has announced updated details for its virtual Stakeholder Briefing scheduled for August 27, 2025, at 4:00 p.m. ET. The webcast will feature a new virtual format and updated participation link, requiring no pre-registration.
The briefing will cover several key areas including strategic and financial overview, Zydus partnership updates, colorectal cancer (CRC) studies, BOT/BAL clinical updates, and Phase 3 BATTMAN study in metastatic CRC. Additionally, the session will spotlight MiNK Therapeutics, where Agenus holds a significant stake.
Distinguished speakers include CEO Garo H. Armen, Chief Development Officer Richard M. Goldberg, and other experts in GI oncology and cancer research. The event will conclude with a live Q&A session.
Agenus (NASDAQ: AGEN), an immuno-oncology company, will host a virtual Stakeholder Briefing on August 27, 2025, at 4:00 p.m. ET. The event will feature presentations from senior management and industry experts focusing on developments in cancer treatment.
Key topics include strategic updates on the botensilimab (BOT) and balstilimab (BAL) programs, progress following the Zydus partnership, colorectal cancer (CRC) studies including the Phase 3 BATTMAN study, and future milestones. Notable speakers include CEO Garo H. Armen, MiNK Therapeutics CEO Jennifer Buell, and newly appointed Chief Development Officer Richard M. Goldberg, along with experts from Duke University and the Canadian Cancer Trials Group.
Agenus (NASDAQ:AGEN) reported Q2 2025 financial results and significant progress in its immunotherapy program. The company's BOT/BAL combination therapy demonstrated a remarkable 42% two-year survival rate in refractory MSS colorectal cancer patients. The FDA has agreed to a streamlined two-arm Phase 3 BATTMAN trial design, set to begin in Q4 2025.
Financial highlights include Q2 2025 revenue of $25.7M and reduced net loss of $56.4M YTD. A strategic collaboration with Zydus Lifesciences is expected to close in Q3 2025, bringing $91M in capital infusion. The company also partnered with Noetik AI for biomarker development and maintains significant ownership in MiNK Therapeutics and SaponiQx.
Agenus (NASDAQ: AGEN), an immuno-oncology company, has scheduled two important upcoming events. The company will first release its Q2 2025 financial results before market opens on August 11, 2025. Following this, Agenus will host a stakeholder briefing in late August to discuss strategic plans, data milestones, and provide updates on their botensilimab (BOT) and balstilimab (BAL) development program.