Zydus Lifesciences Ltd.

Agenus has completed a $141m strategic collaboration with Zydus Lifesciences to accelerate the global development and potential commercialisation of its botensilimab and balstilimab (BOT/BAL) immunotherapy combination programme. The collaboration secures funding and sustained biologics manufacturing capacity in the US for Agenus, supporting clinical development, early access initiatives, and future commercial production. Under the agreement, Agenus has provided Zydus with exclusive rights to develop and commercialise BOT/BAL in Sri Lanka and India, with Agenus eligible for a 5% royalty on net sales from these markets. Key financial terms include a $75m upfront cash payment to Agenus for transferring manufacturing sites in Emeryville and Berkeley, California, a $16m equity investment by Zydus in Agenus common stock (around 2.1 million shares at $7.50 per share), and up to $50m in contingent milestone payments triggered by production orders of BOT+BAL. Last year, the BOT+BAL combination showed a two-year overall survival rate of 42% and a mature median overall survival of 21 months in an expanded cohort of 123 patients with third-line or later microsatellite-stable metastatic colorectal cancer without active liver metastases. Agenus retains committed manufacturing capacity at these US sites for global access programmes, commercialisation, and clinical trials. Agenus received advisory support from Porrima and Biotech Value Advisors (BVA) on partner selection, transaction structure, and negotiations. Agenus chairman and CEO Dr Garo Armen said: “Closing this collaboration with Zydus strengthens our balance sheet and, critically, secures dedicated US manufacturing capacity at a pivotal moment for Agenus. “With these foundations in place, our focus in 2026 is disciplined execution, advancing our Phase III programme, broadening paid patient access through authorised pathways, and progressing toward regulatory submission supported by one of the most substantial clinical datasets generated in MSS colorectal cancer.” In June 2025, Agenus entered a $141m partnership with Zydus Lifesciences and its subsidiaries to strengthen global manufacturing, advance clinical development, and expand access to BOT/BAL. The content above comes from the network. if any infringement, please contact us to modify.

TUESDAY, Jan. 20, 2026 -- The U.S. Food and Drug Administration has approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients. The copper replacement therapy is given by subcutaneous injection. The most common side effects reported with Zycubo included infections, respiratory problems, seizures, vomiting, fever, anemia, and injection site reactions. The FDA said that because copper can accumulate in the body, patients receiving Zycubo should be closely monitored for potential toxicity. The approval is based on results from two open-label, single-arm clinical trials that included 66 treated patients (ages 3 years and younger) and 17 untreated patients. Results showed children who began treatment within four weeks of birth had a 78 percent reduction in the risk for death compared with that seen in untreated patients. Among early-treated patients, nearly half survived beyond six years, with some surviving more than 12 years. No untreated patients survived beyond six years. Substantial survival benefits were also seen in children who started treatment more than four weeks after birth. "With today’s action, children with this devastating, degenerative disease will have an FDA-approved treatment option and the potential to live longer," Christine Nguyen, M.D., of the FDA Center for Drug Evaluation and Research, said in a statement. "The FDA will continue to work with the rare disease community to advance drug development for patients with Menkes disease and other rare conditions." Approval of Zycubo was granted to Sentynl Therapeutics. More Information

AHMEDABAD, India and PENNINGTON, N.J. , Jan. 15, 2026 /CNW/ -- Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as " Zydus ") is an innovation-led life-sciences company with an international presence, today announced the successful closure of the Asset Purchase Agreement, Share Purchase Agreement, and the exclusive Licensing Agreement with Agenus Inc. (NASDAQ: AGEN). This comprehensive closure follows the receipt of all the necessary regulatory approvals, including formal clearance from the Committee on Foreign Investment in the United States (" CFIUS "). The transaction establishes Zydus' advanced manufacturing facilities in the global biologics contract development and manufacturing organization (" CDMO ") business. All acquired manufacturing assets and operations will be housed under a newly formed, dedicated U.S. based subsidiary named Zylidac Bio LLC. Commenting on the finalization of the deal, Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited., stated, "With this deal, Zylidac Bio LLC will now provide biologicals manufacturing sites offering CDMO services to biopharmaceutical companies globally. This supports the evolving landscape of biological product manufacturing in the U.S., which prioritizes secure, domestic, and high-quality supply chains for advanced therapies. Zylidac Bio LLC offers a critical, compliant solution for global innovators and allows for a localized supply chain. It reinforces our ability to serve the international biopharmaceutical industry with reliability and innovation." Dr. Garo Armen, Chairman and CEO of Agenus, Inc., said, "This collaboration unites Agenus' pioneering immunotherapy pipeline and U.S.-based clinical development capabilities with Zydus' global manufacturing, operational scale, and commercial infrastructure. The transaction allows Agenus to monetize manufacturing assets while securing dedicated, high-quality U.S. biologics capacity to support botensilimab and balstilimab. Importantly, it sharpens our focus on advancing BOT and BAL through late-stage development and expanding paid access to patients globally who have limited treatment options." The launch of Zylidac Bio LLC is particularly significant in light of the BIOSECURE Act, signed into law on December 18, 2025, which restricts U.S. executive agencies from contracting with "Biotechnology Companies of Concern". By establishing a secure, domestic manufacturing footprint in California through Zylidac Bio LLC, Zydus provides a "safe-harbor" for global biopharmaceutical companies seeking to transition their supply chains to compliant, U.S.-based partners. Earlier in 2025, Zydus announced Global BioCDMO Services through the acquisition of Agenus Inc.'s state-of-the-art facilities in Emeryville and Berkeley. [Under the exclusive manufacturing agreement, Zydus will be the sole provider for the production of drug substance and drug product for Agenus Inc's Phase 3 immuno-oncology candidates, Botensilimab (BOT) and Balstilimab (BAL). Zydus has secured exclusive rights to commercialize Agenus' lead immuno-oncology assets, BOT and BAL, in India and Sri Lanka. Zydus completed its equity investment in Agenus Inc. through its venture capital arm, Zynext Ventures. This move complements Zydus' recently announced strategic partnership with Formycon to commercialize a Keytruda® biosimilar (FYB206) in North America. Zylidac Bio LLC will allow for a localized supply chain, ensuring agility and security for Zydus' expanding biosimilar and innovative portfolio. Logo: View original content: SOURCE Zydus Lifesciences Limited