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Valneva Provides Update on Chikungunya Vaccine IXCHIQ®

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Saint Herblain (France), January 19, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specia...

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AI Summary

Valneva SE has voluntarily withdrawn its biologics license application and IND for its chikungunya vaccine IXCHIQ in the U.S. due to safety concerns raised by the FDA. This development may hinder Valneva's market position but underscores its commitment to safety and ongoing efforts to engage with global health authorities.

Sentiment Rationale

Historical examples show that regulatory setbacks can lead to significant stock declines. Valneva’s withdrawal may indicate potential long-term challenges in bringing IXCHIQ to market.

Trading Thesis

Valneva's withdrawal could signal short-term volatility, offering a potential buying opportunity at lower prices.

Market-Moving

  • The withdrawal of IXCHIQ may negatively impact future revenue projections.
  • FDA's intervention raises concerns about the safety profile of Valneva's products.
  • Potential future clinical studies may depend on the outcome of safety investigations.
  • Market sentiment could shift based on Valneva's response to regulatory challenges.

Key Facts

  • Valneva withdraws IXCHIQ BLA and IND applications in the U.S.
  • FDA placed IXCHIQ IND on clinical hold due to safety investigation.
  • Valneva emphasizes commitment to high safety standards and global engagement.
  • No active clinical studies for IXCHIQ currently underway.
  • IXCHIQ remains a strategic asset despite regulatory challenges.

Companies Mentioned

  • Pfizer (PFE): Valneva's Lyme disease vaccine candidate is partnered with Pfizer.

Corporate Developments

This development falls under Corporate Developments as it directly affects Valneva's regulatory standing and product pipeline. The decision to withdraw applications highlights ongoing challenges in vaccine approvals which may influence investor sentiment and market positioning.

Valneva Withdraws Chikungunya Vaccine Applications in the U.S.

On January 19, 2026, Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a leading specialty vaccine company, announced its decision to voluntarily withdraw the Biologics License Application (BLA) and Investigational New Drug (IND) application for its chikungunya vaccine, IXCHIQ®, in the United States. This move follows the recent suspension of the vaccine license by the U.S. Food and Drug Administration (FDA) in August 2025.

Details Surrounding the Withdrawal

Valneva's withdrawal comes as the FDA placed the IND on clinical hold pending an investigation into a newly reported foreign Serious Adverse Event (SAE). The company is currently awaiting further information regarding its formal response to the suspension and actively pursuing additional details to clarify the adverse event.

The SAE occurred outside of the U.S. involving a younger adult who received three concomitant vaccines, including IXCHIQ®. Although this case might be plausibly linked to the vaccine, causality has not yet been confirmed.

Future Plans for IXCHIQ®

As there are currently no clinical studies involving IXCHIQ® actively vaccinating participants, Valneva intends to advance its planned post-marketing clinical activities. The company continues to communicate with relevant regulatory authorities and remains committed to maintaining the highest safety standards.

IXCHIQ® primarily targets travelers to regions where the chikungunya virus is endemic, including tropical and subtropical areas in Asia, Africa, and the Americas. Valneva believes that the vaccine’s benefit-risk profile remains favorable, especially for individuals living in endemic and outbreak settings.

Understanding Chikungunya Virus

Chikungunya virus (CHIKV) is transmitted through the bites of infected Aedes mosquitoes, leading to symptoms such as fever, severe joint and muscle pain, headache, and rash. Joint pain can be debilitating and may persist for weeks or even years.

  • Since its re-emergence in 2004, CHIKV has been identified in over 110 countries across Asia, Africa, Europe, and the Americas.
  • From 2013 to 2023, over 3.7 million cases of chikungunya have been reported in the Americas.
  • The World Health Organization (WHO) has categorized chikungunya as a major public health problem.

About Valneva SE

Valneva SE is dedicated to the development, manufacturing, and commercialization of innovative prophylactic vaccines for infectious diseases, addressing unmet medical needs. The company has successfully advanced multiple vaccines from research and development to approval and currently markets three proprietary travel vaccines.

With revenues from its growing commercial business, Valneva plans to further enhance its vaccine pipeline, which includes a Lyme disease vaccine candidate developed in partnership with Pfizer, alongside a Shigella vaccine candidate and others targeting various global public health threats. More information about Valneva can be accessed at www.valneva.com.

Media and Investor Relations Contacts

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Forward-Looking Statements

This article includes forward-looking statements regarding Valneva’s operations, including implications related to regulatory reviews and the product lifecycle of IXCHIQ®. These statements are based on current expectations, subject to various risks and uncertainties that may result in actual outcomes differing significantly from those anticipated.

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