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: November 13, 2026
Commission File Number: 001-40377
Valneva SE
(Translation of registrant's name into English)
Îlot Saint-Joseph, Bureaux Convergence
12ter Quai Perrache
69002 Lyon, 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 November 9, 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).
On November 10, 2026, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.2. 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 | |||||
Exhibit 99.2 | |||||
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: November 13, 2026 | /s/ Thomas Lingelbach | |||||||||||||||||||
Thomas Lingelbach | ||||||||||||||||||||
Chief Executive Officer and President | ||||||||||||||||||||
VALNEVA SE
Îlot Saint-Joseph, Bureaux Convergence, Bât. A,
12 ter Quai Perrache
69002 Lyon, France
Valneva Announces Positive Phase 2 Results for Tetravalent Shigella Vaccine Candidate S4V2
Data from infant immunogenicity and safety trial, and controlled human infection model (CHIM) trial, demonstrate favorable safety profile with encouraging immunogenicity and efficacy signals
Lyon (France), November 9, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive results from two Phase 2 trials of Shigella4V2 (S4V2), the world’s most clinically advanced tetravalent bioconjugate vaccine candidate against shigellosis. Valneva is evaluating the complete dataset of the Phase 2 infant and CHIM trials to determine the most appropriate path forward for the potential first-in-class vaccine candidate.
Shigellosis is the second leading cause of fatal diarrheal disease worldwide, strongly contributing to pediatric morbidity and mortality. It is estimated that up to 165 million infections annually are due to Shigella of which 62.3 million occur in children younger than five years1. Developing an effective vaccine to prevent this deadly disease is a public health imperative for many areas of the world.
The Phase 2 infant trial S4V02 (Identifier: NCT06523231) conducted in Kenya investigated the safety and immunogenicity of two dose levels of S4V2 compared with a control meningococcal vaccine in 110 infants aged nine months. Participants were vaccinated according to a two-dose schedule.
S4V2 showed a favorable safety and tolerability profile across both dose levels evaluated. Most solicited and unsolicited adverse events were mild to moderate in severity and did not differ statistically from the control group. All treatment-related adverse events resolved without complications.
Following the two-dose vaccination schedule, S4V2 induced immune responses with statistically significant increases in anti-LPS IgG antibody levels for all four targeted Shigella serotypes compared with the control group. Geometric Mean antibody Titers peaked after the second dose and remained above baseline levels six months later. Data from this trial provide encouraging evidence of immunogenicity and antibody persistence while highlighting the need for further evaluation of dose selection and vaccination scheduling to optimize the breadth and robustness of the immune response.
The Phase 2 CHIM trial S4V03 (Identifier: NCT06615375), aimed to evaluate the safety, immunogenicity and efficacy of S4V2 in approximately 120 healthy adults aged 18 to 50 years who were seronegative for Shigella at baseline. The trial was conducted across three clinical sites in the United States.
Following confirmation of the selected vaccine dose in Step 1 of the trial, newly enrolled participants received two doses of S4V2 or placebo one month apart. Approximately one month
1Shigellosis | CDC Yellow Book 2024
after the second vaccination, participants were challenged with the Shigella sonnei 53G strain to evaluate the vaccine 's ability to confer protection against S. sonnei 53G-associated shigellosis.
The trial met its primary endpoint with a statistically significant reduction in the incidence of shigellosis due to the S. sonnei serotype among participants who received S4V2 compared with those who received placebo. Further analysis of efficacy and immunogenicity are ongoing.
Hanneke Schuitemaker, Ph.D., Chief Scientific Officer of Valneva, commented "These studies provide important clinical data on the safety, immunogenicity and preliminary efficacy of the S4V2 vaccine candidate. The favorable safety profile observed across both studies, together with the immune responses seen in infants and the achievements of the predefined primary endpoint in the CHIM study, represent positive and encouraging results while underscoring the need for further clinical evaluation and optimization. We will complete the assessment of the full datasets to inform the design of the next steps of clinical development for the vaccine candidate."
The U.S. Food and Drug Administration (FDA) granted Fast Track designation to S4V2 in 20242, recognizing its potential to address a serious condition and fill an unmet medical need.
LimmaTech was the sponsor for both trials. Trial S4V02, conducted in infants, was supported by funding from the Gates Foundation.
About Shigellosis
Shigellosis is a global infectious disease caused by Shigella, a Gram-negative bacterium. An estimated 165 million Shigella infections occur worldwide each year3, including approximately 62.3 million cases in children under five years of age. The disease represents a major public health burden and is a leading cause of diarrheal morbidity and mortality in low- and middle-income countries, as well as among travelers and military personnel deployed to endemic regions. Shigella is estimated to cause up to 600,000 deaths annually and is the second leading cause of fatal diarrheal disease worldwide4.
Current treatment relies primarily on oral rehydration and antibiotic therapy. However, increasing antimicrobial resistance, including the emergence and spread of multidrug-resistant strains, is making infections progressively more difficult to treat and reinforces the urgent need for preventive measures. Despite the significant global burden of disease, there is currently no licensed vaccine available to prevent shigellosis.
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.
2 Valneva and LimmaTech Awarded FDA Fast Track Designation for Tetravalent Shigella Vaccine Candidate S4V - Valneva
3 Shigellosis | CDC Yellow Book 2024
4 Shigellosis | CDC Yellow Book 2024
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 commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate under regulatory review, which is partnered with Pfizer, the world’s most clinically advanced tetravalent Shigella vaccine candidate, as well as vaccine candidates against other global public health threats. More information is available at www.valneva.com.
Valneva Investor and Media 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 the progress, timing, results and completion of research, development and clinical trials for product candidates, to regulatory approval of product candidates and review 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, 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 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.
VALNEVA SE
Îlot Saint-Joseph, Bureaux Convergence, Bât. A,
12 ter Quai Perrache
69002 Lyon, France
Valneva Reports Sustained 94% Seroresponse Five Years After a Single Dose of Chikungunya Vaccine IXCHIQ®
•94% of participants maintained seroresponse five years after a single vaccination
•Comparable antibody persistence observed in older (65+) and younger adults
•Data further reinforce IXCHIQ®'s differentiated profile with durable antibody persistence against an unpredictable outbreak disease
Lyon (France), November 10, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive five-year antibody persistence data for its single dose chikungunya vaccine IXCHIQ®. The results demonstrate durable antibody persistence across all age groups evaluated and are consistent with previously reported persistence results1,2,3,4. The results are in line with Valneva’s expectations for this vaccine, further supporting IXCHIQ®'s differentiated profile and its potential to provide long-term protection following a single vaccination, similarly to other live-attenuated vaccines5,6.
Among the 221 healthy adults who were evaluable at Year 5, 94% maintained neutralizing antibody titers well above the seroresponse threshold7 five years after the single-dose vaccination. Antibody persistence in older adults aged 65 years and above was comparable to that observed in younger adults aged 18 to 64 years, with similar geometric mean titers (GMTs) and seroresponse rates (SRRs).
Hanneke Schuitemaker, Ph.D., Chief Scientific Officer of Valneva, commented, “These five-year data further reinforce IXCHIQ®'s unique value proposition. For diseases such as chikungunya, where outbreaks are difficult to predict, durable immune persistence following a single dose represents a significant public health advantage. This is particularly important not only for travelers, but also for populations living in endemic regions, many of which are in low- and middle-income countries where access to healthcare and vaccination may be more limited.”
Trial VLA1553-303 received funding support from the Coalition for Epidemic Preparedness Innovations (CEPI) and the European Union's Horizon Europe program. Under the study protocol, participants will continue to be followed for up to ten years after vaccination to further characterize the long-term durability of immune responses generated by IXCHIQ®.
1 Valneva Reports Positive 12-Month Antibody Persistence Data for Single-Shot Chikungunya Vaccine Candidate - Valneva
2 Valneva Reports Positive 24-Month Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ® - Valneva; McMahon et al., J TJ Travel Med. 2024 Mar 1;31(2):taad156.doi: 10.1093/jtm/taad156
3 Valneva Reports Positive Three-Year Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ® - Valneva
4 Valneva Reports 95% Seroresponse Four Years After Single Shot of Chikungunya Vaccine IXCHIQ® - Valneva
5 Lindsey NP, Horiuchi KA, Fulton C, Panella AJ, Kosoy OI, Velez JO, Krow-Lucal ER, Fischer M, Staples JE. Persistence of yellow fever virus-specific neutralizing antibodies after vaccination among US travellers. J Travel Med. 2018 Jan 1;25(1):10.1093/jtm/tay108. doi: 10.1093/jtm/tay108. PMID: 30346562; PMCID: PMC7135922.
6 Kamal Desai, L. Coudeville, F. Bailleux, Modelling the long-term persistence of neutralizing antibody in adults after one dose of live attenuated Japanese encephalitis chimeric virus vaccine, Vaccine, Volume 30, Issue 15, 2012, Pages 2510-2515, ISSN 0264-410X, https://doi.org/10.1016/j.vaccine.2012.02.005.https://www.sciencedirect.com/science/article/pii/S0264410X12001697)
7 A neutralizing antibody titer of ≥150 determined by µPRNT50, i.e. the antibody level agreed with regulators as endpoint under the accelerated approval pathway.
Valneva is also continuing to generate real-world evidence for IXCHIQ® through several post-marketing studies and initiatives, including a Pilot Vaccination Strategy (PVS) in Brazil, the first large-scale public vaccination campaign using IXCHIQ®. Conducted between February and October 2026 by the Brazilian Ministry of Health and Instituto Butantan, with support from Valneva, the campaign vaccinated nearly 80,000 adults aged 18 to 59 years. The PVS serves as the foundation for ongoing post-marketing studies6-8, which are expected to generate important effectiveness and safety data and further support the vaccine's public health value.
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 years.8
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 Americas.9 Between 2013 and 2023, more than 3.7 million cases were reported in the Americas10 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.11
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 under regulatory review, 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.
Valneva Investor and Media 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 | ||||
8 https://jvi.asm.org/content/jvi/88/20/11644.full.pdf
9 https://cmr.asm.org/content/31/1/e00104-16
10 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.
11 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas (who.int)
Forward-Looking Statements
This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates, to regulatory approval of product candidates and review 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, 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 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.