Valneva withdraws BLA, IND application for Ixchiq in U.S.

Valneva (VALN) SE announced that the company has decided to voluntarily withdraw the biologics license application, BLA, and Investigational New Drug, IND, application for its chikungunya vaccine, Ixchiq, in the United States, following suspension of the license by the U.S. Food and Drug Administration, FDA, in August 2025. The Company had been awaiting further information with respect to its formal response to the vaccine license suspension. Valneva was recently informed of the FDA’s further decision to now place the Investigational New Drug, IND, on clinical hold pending an investigation of a newly reported foreign Serious Adverse Event, SAE. There are currently no clinical studies involving Ixchiq that are actively vaccinating participants, and the Company intends to move forward with its planned post-marketing clinical activities, subject to further discussions with relevant regulatory authorities.