Valneva SE announced that it and the Serum Institute of India (SII) have mutually agreed to terminate their license agreement for the company’s single‑shot chikungunya vaccine, IXCHIQ. The decision, made on December 31, 2025, allows Valneva to reclaim full rights to the product and to manage its own supply chain and commercialization in high‑risk regions.
The termination follows the U.S. Food and Drug Administration’s suspension of IXCHIQ’s license on August 25, 2025, after reports of serious adverse events. The suspension forced Valneva to shift its commercial focus away from the United States and to reassess its manufacturing strategy. By ending the partnership with SII, Valneva removes a potential source of regulatory risk and positions itself to negotiate new agreements directly with governments and health agencies in endemic countries.
Valneva’s financial performance in the first nine months of 2025 reflected the impact of the FDA action. Total revenue rose to €127.0 million, an 8.9 % increase from the same period in 2024, driven largely by stronger sales of its travel and COVID‑19 vaccine lines. The company had previously revised its 2025 guidance in October, projecting product sales of €155‑170 million and total revenues of €165‑180 million. The FDA suspension prompted a downward adjustment to the guidance, although the company still expects to meet the lower end of its revised range. Net loss for the nine‑month period was €65.2 million, a swing from a net profit in the same period of 2024, largely due to the sale of a Priority Review Voucher in 2024.
Strategically, regaining full control of IXCHIQ allows Valneva to streamline operations and improve margin potential. The company can now scale production at its own facilities, reduce dependence on a contract manufacturer, and accelerate distribution in low‑ and middle‑income countries where the disease burden is highest. The move also signals a shift toward a more vertically integrated model, which management believes will enhance pricing power and reduce supply‑chain disruptions in the face of regulatory uncertainty.
CEO Thomas Lingelbach emphasized that the decision “aligns with Valneva’s long‑term strategy to deliver vaccines where they are most needed and to maintain full oversight of manufacturing and distribution.” He added that the company remains committed to meeting global demand for IXCHIQ while navigating the regulatory landscape in the United States.
The termination does not eliminate the regulatory headwinds; the FDA suspension remains in effect, and Valneva continues to work with regulators to address safety concerns. However, by consolidating control, the company positions itself to respond more flexibly to future market and regulatory developments, potentially improving its competitive stance in the emerging chikungunya vaccine market, which is projected to exceed $500 million annually by 2032.
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