Valneva SE ADR (NASDAQ:VALN) shares dropped 6.6% in premarket trading on Tuesday after the vaccine maker said it has voluntarily withdrawn both its biologics license application and Investigational New Drug application for its chikungunya vaccine, IXCHIQ®, in the United States.
The decision follows the U.S. Food and Drug Administration’s suspension of the vaccine’s license in August 2025. Valneva said it was recently notified that the FDA had placed the IND on clinical hold while it investigates a newly reported foreign Serious Adverse Event.
According to the company, the SAE occurred outside the U.S. in a younger adult who had received three vaccines at the same time, including IXCHIQ®. Valneva said the case may be “plausibly related” to IXCHIQ® vaccination, although a causal link has not been established. The company said it is working to obtain further details to better assess the event.
Valneva noted that there are currently no active clinical trials vaccinating participants with IXCHIQ®. The company plans to continue with previously outlined post-marketing clinical activities, subject to further discussions with regulatory authorities.
Outside the United States, Valneva said it remains in dialogue with health regulators in regions where IXCHIQ® is already approved, including Europe, Canada, the United Kingdom and Brazil. The company reiterated its view that the vaccine’s benefit-risk profile remains favorable for travelers to chikungunya-endemic regions and for people living in endemic or outbreak areas.
Chikungunya is a mosquito-borne viral illness that can cause fever, severe joint and muscle pain, headache, nausea, fatigue and rash. In some cases, joint pain can persist for months or even years, and the disease has been reported in more than 110 countries worldwide.