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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) said it has expanded its global Medical Affairs infrastructure to support growing physician requests for authorized access to the investigational combination botensilimab plus balstilimab (BOT+BAL).
The company highlighted increasing use of regulatory-authorized early access pathways, including France’s AAC framework (now reimbursed for three tumor types) and paid named-patient programs in multiple countries where permitted, with patients already treated under these programs.
Medical Affairs expansion aims to support compliant access, pharmacovigilance, safety monitoring, and real-world data collection; BOT+BAL remains investigational and is limited to clinical trials in the United States.
Agenus (Nasdaq: AGEN) will host its first 2026 Stakeholder Webcast, "Access to Acceleration: Agenus' Global Momentum Entering 2026," on Wednesday, January 28, 2026 at 4:00 p.m. ET. The webcast will review global access pathways, strategic partnerships, and operational readiness driving the BOT+BAL (botensilimab + balstilimab) program into 2026.
Speakers include CEO Garo Armen, sarcoma expert Robin Jones, and CMOs José Iglesias, covering a recent collaboration with Zydus Lifesciences, France's AAC expansion to sarcoma, Phase 3 readiness, and a live Q&A. Registration is via the provided Vimeo event link; questions may be emailed to ask@agenusbio.com.
Zydus Lifesciences (NASDAQ:AGEN) completed the acquisition of Agenus' Emeryville and Berkeley biologics manufacturing facilities and launched Zylidac Bio LLC in the U.S. The transaction closed after receiving all required approvals including CFIUS clearance and includes an exclusive manufacturing agreement to produce drug substance and drug product for Agenus' Phase 3 immuno-oncology candidates, botensilimab and balstilimab. Zydus also secured exclusive commercialization rights for BOT and BAL in India and Sri Lanka and completed an equity investment via Zynext Ventures. The move aligns with U.S. BIOSECURE Act considerations by expanding secure domestic capacity.
Agenus (Nasdaq: AGEN) closed a strategic collaboration with Zydus Lifesciences that provides $141 million in potential value and committed U.S. biologics manufacturing capacity to advance the BOT+BAL immunotherapy program.
Deal components: $75M upfront for transfer of Emeryville and Berkeley manufacturing facilities, a $16M equity investment (≈2.1M shares at $7.50), and up to $50M in contingent milestone payments tied to production orders. Zydus receives exclusive rights in India and Sri Lanka with Agenus eligible for a 5% royalty on net sales there.
Clinical context: BOT+BAL showed a two-year overall survival of 42% and a median overall survival of 21 months in an expanded 123‑patient MSS mCRC cohort; the global BATTMAN Phase 3 trial is active.
Agenus (Nasdaq: AGEN) said France’s ANSM approved an updated national AAC protocol on January 12, 2026 to expand reimbursed, hospital‑based compassionate access to the investigational immunotherapy combo botensilimab (BOT) + balstilimab (BAL).
The protocol broadens eligibility beyond MSS metastatic colorectal cancer without active liver metastases to include certain platinum‑refractory or -resistant ovarian cancers and advanced/metastatic soft‑tissue sarcomas, standardizing administration, monitoring, and data collection under France’s national health oversight. BOT+BAL remains investigational and is not approved for commercial marketing.
Agenus (Nasdaq: AGEN) reported peer-reviewed Phase 1b results for botensilimab + balstilimab (BOT+BAL) in treatment-refractory ovarian cancer.
The 44-patient cohort showed a 23% overall response rate, 31% clinical benefit rate, median duration of response 9.7 months, median overall survival 14.8 months, and an estimated 75% 12-month survival. Most patients were platinum-resistant or platinum-refractory.
Safety was manageable: common treatment-related adverse events included diarrhea/colitis (43%; 16% grade 3), fatigue and nausea (36%), and no treatment-related deaths.
Agenus (Nasdaq: AGEN) will host an End-of-Year 2025 Stakeholder Webcast on December 3, 2025 at 4:00 p.m. ET. The webcast features GI oncology experts and patient advocates discussing progress of the BOT/BAL program, emerging clinical insights, and the evolving colorectal cancer treatment landscape.
Speakers include Dr. Christopher Lieu, Dr. Jonathan Loree, and Dr. Benny Johnson; session moderated by Garo Armen, PhD, and ending with a live Q&A. Registration is required; a live webcast link is provided after registering and questions may be submitted in advance to ask@agenusbio.com. This is the third session in Agenus’ 2025 Stakeholder Briefing Webcast Series.
Agenus (Nasdaq: AGEN) appointed Dr. José Iglesias as Chief Medical Affairs Officer effective November 10, 2025 to lead global medical affairs for the BOT/BAL combination as it advances through the Phase 3 BATTMAN program.
Dr. Iglesias will oversee medical evidence generation, scientific exchange, and early-access frameworks, including France’s Autorisation d’Accès Compassionnel (AAC), where BOT/BAL has received AAC authorization with full government reimbursement and treatment has begun for eligible MSS colorectal cancer patients. Agenus plans named-patient and other early-access programs in additional geographies and emphasizes collecting robust real-world evidence.
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.
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