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Agenus Inc. develops immuno-oncology therapies for cancer, with recurring updates centered on botensilimab (BOT) and balstilimab (BAL), its CTLA-4/PD-1 immunotherapy combination. Company news regularly covers clinical data in solid tumors, including metastatic colorectal cancer, melanoma and gastroesophageal cancer, as well as translational biomarker work and combination approaches that use antibody therapeutics, adoptive cell therapy through MiNK Therapeutics and adjuvants.
Agenus updates also address regulatory-authorized access pathways for BOT+BAL, including France's AAC framework and paid named-patient programs where permitted, along with financial results, equity financing activity, commercial readiness, manufacturing collaborations and corporate governance developments.
Agenus (Nasdaq: AGEN) reported a peer-reviewed publication of mature Phase 1b data from the C-800-01 cohort evaluating botensilimab (BOT) plus balstilimab (BAL) in 123 heavily pretreated microsatellite-stable metastatic colorectal cancer patients without active liver metastases.
According to Agenus, BOT+BAL achieved a median overall survival of 21.2 months, with 24- and 36-month overall survival rates of 41% and 33%, respectively, a confirmed objective response rate of 21% (3 complete, 23 partial responses), and a disease control rate of 69% at six weeks. Median duration of response was not reached, with responses lasting at least 37.4 months, and 17% of patients were alive and off systemic anticancer therapy at last follow-up.
Exploratory biomarker analyses showed responses in tumors with low tumor mutational burden and no PD-L1 expression, consistent with BOT’s Fc-enhanced immune-priming design. Extended safety follow-up revealed no new safety signals or treatment-related deaths, and efficacy was similar across BOT 1 mg/kg and 2 mg/kg dosing, with fewer immune-mediated adverse events at the lower dose.
Agenus (Nasdaq: AGEN) reported updated peer-reviewed Phase 2 NEST data of neoadjuvant botensilimab (BOT) plus balstilimab (BAL) in resectable colorectal cancer, showing no colorectal cancer recurrences at the March 31, 2026 cutoff, with median follow-up of 32.2 months in NEST-1 and 23.5 months in NEST-2.
Among 22 pMMR/MSS tumors, neoadjuvant BOT+BAL achieved a 59% pathologic response, including 41% major pathologic response and 32% pathologic complete response. 88% of evaluable patients with baseline ctDNA cleared ctDNA before surgery, which proceeded without treatment-related delays. No Grade 4 treatment-related adverse events, treatment-related deaths or study discontinuations were observed.
According to Agenus, these longer follow-up and immune microenvironment findings support its planned global Phase 3 ROBBIN trial in high-risk Stage II/III MSS colon cancer and the multicenter Phase 2 NEST3 study.
Agenus (Nasdaq: AGEN) reported second quarter 2026 revenue of $34.5 million, up from $25.7 million a year earlier, including $6.4 million in pre-commercial BOT+BAL revenue and $28.1 million in non-cash royalty revenue. Operating income was $11.3 million versus a $16.7 million loss, and net loss was $0.6 million. Cash was $18.7 million at quarter-end, excluding an oversubscribed July private placement that raised $85 million upfront with up to $255 million in potential warrant proceeds.
The financing is expected to fund ROBBIN, a planned global Phase 3 trial of neoadjuvant BOT+BAL in about 850 high-risk Stage II/III MSS colon cancer patients, targeting an annual U.S. market of roughly 38,000 patients. ROBBIN initiation and first dosing are anticipated in Q1 2027. Agenus highlighted NEST/UNICORN neoadjuvant data showing ~30% pCR and ~40% MPR among 38 patients, and metastatic data with median overall survival of 21.2 months in refractory MSS colorectal cancer. The company grew BOT+BAL access-program revenue and, to prioritize ROBBIN, stopped future funding for the CCTG-sponsored BATTMAN Phase 3 trial, which CCTG then terminated.
Agenus (Nasdaq: AGEN) announced it will release its second quarter 2026 financial results before the market opens on Thursday, August 6, 2026. The company also plans a webcast later in August to review corporate priorities.
According to Agenus, the webcast will address acceleration of the botensilimab and balstilimab (BOT+BAL) immunotherapy combination in neoadjuvant colon cancer through the Phase 3 ROBBIN trial, upcoming clinical and data milestones, and ongoing initiatives to support patient access to BOT+BAL. Detailed webcast agenda and access information will be provided closer to the event.
Agenus (Nasdaq: AGEN) announced acceptance of three investigator-sponsored abstracts evaluating its botensilimab plus balstilimab (BOT+BAL) combination for presentation at the ESMO Congress 2026, held October 23-27, 2026, in Madrid, Spain.
The posters cover neoadjuvant mismatch repair-deficient colorectal cancer (NEOASIS), real-world refractory MSS/pMMR metastatic colorectal cancer, and real-world advanced sarcomas, with specific colon cancer and sarcoma sessions scheduled on October 25 and 26, 2026.
Agenus (Nasdaq: AGEN) has entered a securities purchase agreement for an oversubscribed private placement providing approximately $85 million in upfront gross proceeds and up to an additional $255 million upon full exercise of Series A and Series B warrants, for total potential proceeds of $340 million. The financing, led by Commodore Capital with several specialist investors, is priced at a premium to the July 10, 2026 closing share price and is expected, assuming full warrant exercise, to fund completion of ROBBIN, a planned 850‑patient global Phase 3 trial of neoadjuvant botensilimab plus balstilimab (BOT+BAL) in high‑risk Stage II/III MSS colon cancer, and support operations through year‑end 2031.
Agenus is prioritizing neoadjuvant BOT+BAL based on Phase 2 NEST and UNICORN data showing pathologic response in ~60‑70% of patients and pathologic complete response in ~30%, and will discontinue financial support for the BATTMAN Phase 3 metastatic MSS colorectal cancer study.
Agenus (Nasdaq: AGEN) reported three-year Phase 1b data for botensilimab (BOT) + balstilimab (BAL) in 123 patients with refractory MSS metastatic colorectal cancer without active liver metastases.
Median overall survival was 21.2 months, with 33% three-year OS and 17% of patients alive and off systemic anticancer therapy. No new safety signals or treatment-related deaths were observed; 98% of immune-mediated diarrhea/colitis cases resolved. The BOT 1 mg/kg + BAL regimen showed lower diarrhea/colitis rates than 2 mg/kg and supports the ongoing randomized Phase 3 BATTMAN trial in MSS/pMMR metastatic colorectal cancer.
Agenus (Nasdaq: AGEN) will present three-year survival data from its Phase 1b C-800-01 BOT+BAL study in microsatellite-stable metastatic colorectal cancer without active liver metastases at ESMO GI 2026 in Munich.
The poster covers updated findings from the fully enrolled 123-patient cohort, including longer-term durability of response and overall survival, reflecting an additional year of follow-up beyond prior two-year data.
Agenus (NASDAQ: AGEN) announced its 2026 Annual Shareholders Meeting will be held virtually only on June 16, 2026, at 10:00 a.m. ET, with registration starting at 9:45 a.m. ET.
Shareholders of record as of April 22, 2026, can vote and access the meeting online.
Agenus (Nasdaq: AGEN) reported retrospective ASCO 2026 data using Noetik’s AI TARIO-2 platform to analyze routine pretreatment H&E tumor images from 113 patients treated with botensilimab (BOT) plus balstilimab (BAL).
In refractory MSS metastatic colorectal cancer without active liver metastases, an AI-identified subgroup showed a 64% response rate to BOT+BAL versus 9% in the remaining cohort, and significantly better overall survival, with median OS not reached and a hazard ratio of 0.18. TARIO-2 outperformed benchmark pathology foundation models and may support future image-based biomarker strategies for BOT+BAL, subject to prospective validation.