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Investing.com -- Valneva SE ADR (NASDAQ:VALN) stock tumbled 20.4% premarket Monday after the U.S. Food and Drug Administration (FDA) suspended the license for its chikungunya vaccine IXCHIQ, citing four new reports of serious adverse events.
The suspension, effective immediately, requires Valneva to stop shipping and selling IXCHIQ in the United States. This action comes just days after the FDA had lifted its recommended pause on using the vaccine in individuals 60 years and older on August 6.
According to the company, the FDA based its decision on updated data from the Vaccine Adverse Event Reporting System, which included four additional serious adverse events that occurred outside the United States. Three cases involved individuals aged 70 to 82 years, with one requiring hospitalization, while the fourth case affected a 55-year-old individual.
Valneva stated that all reported cases describe symptoms consistent with those previously reported during clinical trials and post-marketing experience. The company is investigating these cases and may pursue further steps regarding the FDA’s decision.
"As we determine potential next steps, and as the clear threat of chikungunya continues to escalate globally, Valneva remains fully committed to maintaining access to our vaccine," said Thomas Lingelbach, Valneva’s Chief Executive Officer.
The company is evaluating the potential financial impact of a permanent withdrawal of the IXCHIQ license in the United States but has not modified its revenue guidance. Sales of IXCHIQ contributed €7.5 million to Valneva’s €91 million total product sales in the first half of 2025.
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