Valneva (Nasdaq: VALN) pulls U.S. IXCHIQ chikungunya vaccine applications

Rhea-AI Filing Summary

Valneva SE reports that it has voluntarily withdrawn the U.S. biologics license application (BLA) and Investigational New Drug (IND) application for its chikungunya vaccine IXCHIQ®. This follows the U.S. FDA’s earlier suspension of the IXCHIQ license in August 2025 and a more recent FDA decision to place the IND on clinical hold while it investigates a newly reported serious adverse event (SAE) from outside the U.S.

The SAE involved a younger adult who received three vaccines at the same time, including IXCHIQ; based on available data, the case may be plausibly related to IXCHIQ, but causality has not been determined. Valneva states that no IXCHIQ clinical studies are currently vaccinating participants and that it plans to continue post-marketing clinical activities after further discussions with regulators. The company continues to supply IXCHIQ in territories where it is licensed, including Europe, Canada, the United Kingdom and Brazil, and maintains that the vaccine’s benefit–risk profile remains favorable, particularly for people in endemic and outbreak settings.

Positive

• None.

Negative

• Valneva voluntarily withdraws the U.S. BLA and IND for IXCHIQ®, removing its immediate U.S. regulatory pathway after the FDA suspended the license and placed the IND on clinical hold.
• A serious adverse event case plausibly related to IXCHIQ® is under investigation, adding safety and regulatory uncertainty even though causality has not been determined.
• U.S. commercialization prospects for IXCHIQ® become uncertain while the company reassesses the global product opportunity based on medical need and commercial attractiveness.

Insights

Biopharmaceutical and regulatory affairs analyst

Valneva pulls U.S. IXCHIQ filings amid FDA license suspension and SAE review.

Valneva has chosen to withdraw the U.S. BLA and IND for its chikungunya vaccine IXCHIQ after the FDA suspended the product’s license in August 2025 and subsequently placed the IND on clinical hold. This removes, for now, the U.S. regulatory pathway for IXCHIQ and shifts the near-term focus to markets where the vaccine is already licensed.

The serious adverse event under review occurred abroad in a younger adult who received three concomitant vaccines, including IXCHIQ; available information suggests the case may be plausibly related to IXCHIQ, though no causal link has been established. Regulatory authorities are investigating, and Valneva reports it has filed the case with VAERS and other pharmacovigilance systems in line with the product license.

Valneva emphasizes that no IXCHIQ clinical studies are currently vaccinating participants and that it still plans post-marketing clinical activities, subject to further regulatory discussions. The company continues to describe IXCHIQ’s benefit–risk profile as favorable, especially for people in endemic or outbreak settings, but future U.S. prospects will depend on the outcome of safety investigations and any subsequent regulatory interactions.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report: January 19, 2026

Commission File Number: 001-40377

Valneva SE

(Translation of registrant's name into English)

6 rue Alain Bombard

44800 Saint-Herblain, France

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

On January 19, 2026, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1. The information contained in this Form 6-K is hereby incorporated by reference into the registrant's registration Statement on Form F-3 (File No. 333-268071).

Exhibit
Exhibit 99.1			Press release dated January 19, 2026

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Valneva SE (Registrant)

Date: January 19, 2026

/s/ Thomas Lingelbach

Thomas Lingelbach

Chief Executive Officer and President

Valneva Provides Update on Chikungunya Vaccine IXCHIQ®

•Company voluntarily withdraws IXCHIQ BLA and IND in the U.S.

•Continuing review of global product opportunity according to medical need and commercial attractiveness

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

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 products 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 is committed to upholding the highest safety standards, and the Company 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 continues to believe 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.

About Chikungunya

Chikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years1.

In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas2. Between 2013 and 2023, more than 3.7 million cases were

1 https://jvi.asm.org/content/jvi/88/20/11644.full.pdf

2 https://cmr.asm.org/content/31/1/e00104-16

reported in the Americas3 and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem.4

About Valneva SE

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.

We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines.

Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against other global public health threats. More information is available at www.valneva.com.

Media and Investor Relations Contacts

Laetitia Bachelot-Fontaine VP Global Communications & European Investor Relations M +33 (0)6 4516 7099 laetitia.bachelot-fontaine@valneva.com     Joshua Drumm, Ph.D. VP Global Investor Relations M +001 917 815 4520 joshua.drumm@valneva.com

Forward-Looking Statements

This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to use, regulatory review, sales, and safety of existing products. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results or new adverse events, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other

3 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed 01 Aug 2023.

4 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas (who.int)

proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

FAQ

What did Valneva (VALN) announce about its chikungunya vaccine IXCHIQreg?

Valneva announced that it has voluntarily withdrawn both the biologics license application (BLA) and the Investigational New Drug (IND) application for its chikungunya vaccine IXCHIQreg in the United States. This follows the U.S. FDAs earlier suspension of the IXCHIQ license and a decision to place the IND on clinical hold.

Why were IXCHIQregs U.S. BLA and IND withdrawn by Valneva (VALN)?

The withdrawal comes after the FDA suspended the IXCHIQ license in August 2025 and later decided to place the IND on clinical hold pending investigation of a newly reported foreign serious adverse event (SAE) in a person who received three concomitant vaccines, including IXCHIQ.

What is known about the serious adverse event linked to IXCHIQreg in Valnevas update?

The SAE occurred outside the U.S. in a younger adult who received three vaccines at the same time, including IXCHIQreg. Based on the information available to Valneva, the case may be plausibly related to IXCHIQ vaccination, but causality has not been determined. The case has been reported to VAERS and other pharmacovigilance systems.

Are there ongoing clinical studies currently vaccinating with IXCHIQreg, according to Valneva (VALN)?

Valneva states that there are currently no clinical studies involving IXCHIQreg that are actively vaccinating participants. The company plans to move forward with post-marketing clinical activities, subject to further discussions with relevant regulatory authorities.

Is Valneva (VALN) still supplying IXCHIQreg outside the United States?

Yes. Valneva indicates it continues to engage with health authorities in territories where IXCHIQreg is licensed, including Europe, Canada, the United Kingdom and Brazil. The vaccine is focused on travelers to endemic regions and people for whom vaccination is medically justified under approved labels and guidance.

How does Valneva (VALN) describe IXCHIQregs benefitrisk profile in this update?

Valneva continues to state that IXCHIQregs benefitrisk profile remains favorable for people living in endemic and outbreak settings. The company notes IXCHIQ may be uniquely positioned as a highly durable single-shot vaccine for chikungunya in those environments.

What is chikungunya and why is it a public health concern highlighted by Valneva (VALN)?

Chikungunya is a mosquito-borne viral disease that can cause fever and often debilitating joint pain that may last weeks to years. Since 2004 it has spread widely, with more than 3.7 million reported cases in the Americas between 2013 and 2023. The World Health Organization has identified chikungunya as a major public health problem.