Valneva SE (NASDAQ:VALN) on Monday said it has decided to voluntarily withdraw the biologics license application (BLA) and Investigational New Drug (IND) application for its chikungunya vaccine, Ixchiq, in the U.S.
In August 2025, the U.S. Food and Drug Administration (FDA) suspended the license for Ixchiq, citing four new reports of serious adverse events (SAEs) consistent with chikungunya-like illness.
The company had been awaiting further information regarding its formal response to the vaccine license suspension. Valneva was recently informed that the FDA has now placed 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.
The SAE occurred outside of the U.S. and involved a younger adult who received three concomitant vaccines, including Ixchiq. Based on the information made available to Valneva, which the company submitted to the U.S. Vaccine Adverse Event Reporting System (VAERS) as well as to all other pharmacovigilance systems in accordance with the product’s license, the case may be plausibly related to Ixchiq vaccination, but causality has not been determined.
The company is actively seeking additional information to further characterize the case.
Valneva continues to engage proactively with health authorities in all territories where Ixchiq is licensed, including Europe, Canada, the United Kingdom, and Brazil.
While Ixchiq is currently focused on travelers to regions where the virus is endemic, such as tropical and subtropical areas in Asia, Africa, and the Americas, and persons for whom vaccination is medically justified based on risk in accordance with the approved label and vaccination guidance, the company on Monday said that Ixchiq’s benefit-risk profile also remains favorable for people living in the endemic and outbreak settings, where Ixchiq may be uniquely positioned as a highly durable single-shot vaccine.
In November 2025, Valneva shared final immunogenicity and safety data on Wednesday from the Phase 2 study, VLA15-221, of the Lyme disease vaccine candidate, VLA15.
Subject to positive Phase 3 data, the partner, Pfizer Inc. (NYSE:PFE), aims to submit a Biologics License Application to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency in 2026.
Price Action: VALN stock is down 4.37% at $9.63 at the last check on Tuesday.
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