Valneva SE has voluntarily withdrawn its U.S. biologics license application and investigational new drug for its chikungunya vaccine IXCHIQ, following the FDA’s August 2025 suspension of the product’s U.S. license.
The FDA’s suspension was triggered by a cluster of serious adverse events, including deaths and hospitalizations, and a clinical hold was placed on the IND after a new serious adverse event involving a younger adult who received IXCHIQ alongside other vaccines outside the U.S. The company indicated the case may be plausibly related to IXCHIQ, but causality has not been established.
The withdrawal eliminates a projected U.S. revenue stream that Valneva had factored into its 2025 guidance. The company had forecast product sales of 155‑170 million EUR for the full year, with cash reserves of 143.5 million EUR and a net loss of 65.2 million EUR in the first nine months of 2025. Losing U.S. sales will tighten the company’s cash runway and could constrain future pipeline investments.
Valneva said it will continue to engage with regulators in territories where IXCHIQ remains licensed, including Europe, Canada, the United Kingdom and Brazil, and will focus on post‑marketing studies and potential repositioning in low‑ and middle‑income countries. The company maintains that the benefit‑risk profile of IXCHIQ remains favorable for travelers to endemic regions and for residents in outbreak settings.
The decision leaves Bavarian Nordic’s Vimkunya as the sole chikungunya vaccine available in the U.S. market. Valneva’s strategic pivot away from the U.S. for IXCHIQ underscores the regulatory risk associated with live‑attenuated vaccines and signals a shift in the company’s commercial focus toward markets where the product is still approved.
The withdrawal also highlights the broader challenges facing Valneva’s vaccine portfolio, including the need for robust safety surveillance and the impact of regulatory actions on commercial prospects. The company’s other pipeline assets, such as a Lyme disease vaccine in partnership with Pfizer, will become increasingly important as it seeks to offset the loss of U.S. IXCHIQ sales.
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