Valneva
ENXTPA:VLA
€
2,69
€
+
€0,11 (4,26%)
2,69
€
+€0,11 (4,26%)
End-of-day quote: 04/08/2026
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Valneva Company Info
EPS Growth 5Y
-31,95%
Market Cap
€0,47 B
Long-Term Debt
€0,16 B
Annual earnings
N/A
Dividend
€0,00
Dividend Yield
0,00%
Founded
1998
Industry
Country
Website
ISIN Number
Website
Analyst Price Target
The Analyst Price Target shows the analysts’ low, high, and average target at a glance.
€5,60
108.18%
Last Update: 04/09/2026
Analysts: 6
Highest Price Target €8,50
Average Price Target €5,60
Lowest Price Target €3,25
In the last five quarters, Valneva’s Price Target has fallen from €7,91 to €6,69 - a -15,42% decrease. Five analysts predict that Valneva’s share price will increase in the coming year, reaching €5,60. This would represent an increase of 108,18%.
Top growth stocks in the health care sector (5Y.)
What does Valneva do?
Valneva SE is a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.
The company takes a highly specialized and targeted approach, applying the company’s deep expertise across multiple vaccine modalities, focused on providing either first-, best-, or only-in-class vaccine solutions. The company has a strong track record, having advanced multiple vaccines from early Research & Development (R&D) to...
Valneva SE is a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.
The company takes a highly specialized and targeted approach, applying the company’s deep expertise across multiple vaccine modalities, focused on providing either first-, best-, or only-in-class vaccine solutions. The company has a strong track record, having advanced multiple vaccines from early Research & Development (R&D) to approvals, and markets three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, IXCHIQ, as well as certain third-party vaccines.
Revenues from the company's growing commercial business help fuel the continued advancement of the company's vaccine development pipeline. The company's clinical portfolio is composed of highly differentiated vaccine candidates that are designed to provide preventative solutions for diseases with high unmet need. The company's pipeline includes the only Lyme disease vaccine candidate (VLA15) in advanced clinical development, which it is developing in partnership with Pfizer, as well as the world’s most clinically advanced tetravalent Shigella vaccine candidate, under development in collaboration with LimmaTech Biologics AG (LimmaTech), and proprietary vaccine candidates against the Zika virus and other global public health threats.
VLA15 is a Phase 3 vaccine candidate targeting Borrelia, the bacterium that causes Lyme disease, under development in collaboration with Pfizer, and it is the only vaccine candidate against Lyme disease undergoing late-stage clinical trials. Pfizer and Valneva are executing the Phase 3 field efficacy study for VLA15, called VALOR (Vaccine Against Lyme for Outdoor Recreationists). Enrollment in the trial was completed in December 2023, and the primary vaccination series was completed in July 2024. Participants will be monitored for the occurrence of Lyme disease cases until the end of the Lyme disease season in 2025.
VLA1553 is a vaccine candidate that was approved by the U.S. Food and Drug Administration (FDA), the European Commission (EC), Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) under the brand name IXCHIQ. It is indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older. At the end of February 2024, the U.S. Advisory Committee on Immunization Practices (ACIP) provided recommendations on how to use IXCHIQ, and these recommendations were then adopted by the U.S. Centers for Disease Control and Prevention (CDC). In 2024, Valneva submitted label extension applications to the FDA, the European Medicines Agency (EMA), and Health Canada to potentially extend the use of IXCHIQ, which is currently approved in adults, to adolescents 12 to 17 years of age. The applications to the FDA and Health Canada also included the two-year antibody persistence data to the product label, which is a key differentiator for IXCHIQ. In February 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending authorization of a label extension for IXCHIQ in adolescents 12 years of age and older. The EC will review the CHMP recommendation, and a decision on the label extension application in the European Union (EU), Norway, Liechtenstein, and Iceland is expected within sixty days following the CHMP opinion. A marketing application is also under review in Brazil, which would represent the first approval in an endemic country. The vaccine is still undergoing several clinical trials with a view to expand access, support label extensions, and enhance the product profile.
VLA1601 is a Phase 1 vaccine candidate targeting the Zika virus (ZIKV), a mosquito-borne viral disease whose transmission has been reported in 89 countries and territories and persists in several countries in the Americas and other endemic regions. There are no preventive vaccines or effective treatments available. As such, Zika remains a public health threat and is included in the FDA’s Tropical Disease Priority Review Voucher Program. VLA1601 is being developed on the original manufacturing platform of the company's licensed Japanese encephalitis vaccine IXIARO, which was further optimized to develop the company's inactivated, adjuvanted COVID-19 vaccine VLA2001, the first COVID-19 vaccine to receive a standard marketing authorization in Europe.
The company has already successfully licensed and commercialized a portfolio of traveler vaccines, which is composed of IXIARO (also marketed as JESPECT in Australia and New Zealand), indicated for the prevention of Japanese encephalitis in travelers and military personnel, and DUKORAL, indicated for the prevention of cholera and, in Canada, Switzerland, New Zealand, and Thailand, prevention of diarrhea caused by Enterotoxigenic Escherichia coli, or ETEC, the leading cause of travelers’ diarrhea. At the beginning of 2024, the company launched its chikungunya vaccine IXCHIQ in the U.S. Additionally, the company distributes vaccines for third parties in selected countries where the company has a commercial infrastructure.
The company has a highly developed, nimble and sophisticated manufacturing infrastructure with facilities across Europe to meet the company’s clinical and commercial needs, including BioSafety Level 3 (BSL-3) manufacturing and R&D facilities. The company has assembled a team of experts with deep scientific, clinical and business expertise in biotechnology and specifically in vaccine development, manufacturing and commercialization. The company’s senior leadership team has extensive experience and demonstrated ability to move vaccines through the clinic and into successful commercialization. Members of the company’s team have previously worked at industry leaders such as Novartis, Chiron, GlaxoSmithKline and Daiichi Sankyo.
Pipeline and Proprietary Commercial Portfolio
The company’s pipeline consists of assets at all stages of research & development. The company’s intention is to develop vaccine candidates that are first-, best-, or only-in-class and address unmet needs in infectious diseases. The company’s intention is to develop these assets for future commercialization either in-house or through and with partners.
The company’s clinical pipeline includes:
VLA15 - a vaccine candidate against Borrelia, the bacterium that causes Lyme disease. VLA15 is a multivalent recombinant protein vaccine that targets six serotypes of Borrelia, representing the most common serotypes found in North America and Europe. VLA15 is the only Lyme disease program in advanced clinical development today and has received Fast Track designation from the FDA. The company reported results for three Phase 2 clinical trials of VLA15 in both adult and pediatric populations, in which it observed high levels of antibodies against all six serotypes. These include the announcement in September 2023 of positive Phase 2 pediatric and adolescent immunogenicity and safety data following a booster vaccination with VLA15. In August 2022, jointly with Pfizer, the company initiated a Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR), to investigate the efficacy, safety, and immunogenicity of VLA15 in participants five years of age and older in highly endemic regions in the United States and Europe. In February 2023, Pfizer, as the study sponsor, decided to discontinue approximately half of the total enrolled participants in the trial following violations of Good Clinical Practice, or GCP, at certain clinical trial sites run by a third-party clinical trial site operator. The clinical trial remains ongoing with other sites not operated by the third party and new sites in the U.S. and Canada. In December 2023, the company and Pfizer announced that they completed recruitment for the study. In July 2024, the company announced completion of the primary vaccination series. Participants will receive their remaining booster dose and then be monitored for the occurrence of Lyme disease cases until the end of the Lyme disease season in 2025. Subject to positive data, Pfizer intends to submit a Biologics License Application (BLA) to the FDA and a marketing authorization application (MAA) to the EMA in 2026.
VLA1553 – a single-dose, live-attenuated vaccine candidate against CHIKV. VLA1553 was approved by the FDA under the brand name IXCHIQ in November 2023, and with this approval, it became the world’s first licensed chikungunya vaccine available to address this unmet medical need. It is indicated in the United States for the prevention of disease caused by CHIKV in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. Alongside the approval, the company received a Priority Review Voucher, which it sold for $103 million in February 2024. At the end of February 2024, the ACIP provided recommendations on how to use IXCHIQ, and these recommendations were then adopted by the CDC. The company expects expanded access to the retail channel via publication of the ACIP recommendations in the Morbidity and Mortality Weekly Report (MMWR). IXCHIQ was also approved in Canada in June 2024, in Europe in July 2024, and in the UK in February 2025 for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. A marketing application is also under review in Brazil. Label extensions to potentially extend the use of IXCHIQ to adolescents aged 12 to 17 years are also under review in the U.S., Europe, and Canada. In February 2025, the Committee for Medicinal Products for Human Use of the EMA adopted a positive opinion recommending authorization of a label extension for IXCHIQ to individuals 12 years of age and older. The recommendation is now being reviewed by the EC, and a decision on the label extension is expected within sixty days. The company has continued to evaluate antibody persistence in a dedicated trial that will extend over ten years. Additionally, a clinical study in 754 adolescents 12 to 17 years of age, VLA1553-321, is ongoing in Brazil, for which the company reported positive pivotal Phase 3 immunogenicity and safety data in November 2023. Funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and conducted in collaboration with Instituto Butantan, this adolescent trial is intended to support the label extension in this age group following approvals in adults. The trial is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in endemic populations. The company also initiated a pediatric trial in children 1 to 11 years of age, VLA1553-221, in January 2024 to support a Phase 3 pivotal pediatric study and potentially extend the label to this age group following initial regulatory approvals in adults and possibly in adolescents. In 2025, the company will also start preparing for the initiation of two Phase 4 post-marketing studies required as part of its approval under the FDA’s accelerated approval pathway.
S4V2 – a tetravalent bioconjugate vaccine candidate against shigellosis, a diarrheal infection caused by Shigella bacteria, under development in collaboration with LimmaTech. In October 2024, the company announced the launch of a Phase 2b controlled human infection model (CHIM) study to assess the safety and preliminary efficacy in approximately 120 healthy Shigella-naïve participants aged 18 to 50 years at three sites in the United States. In addition to the CHIM study, LimmaTech will conduct a Phase 2 pediatric study in LMICs expected to begin in the first half of 2025. Valneva will assume all further development, including CMC (chemistry, manufacturing, and controls) and regulatory activities, and will be responsible for its commercialization worldwide, if approved. Shigellosis is the second leading cause of fatal diarrheal disease worldwide. It is estimated that up to 165 million cases of disease and an estimated 600,000 deaths are attributed to Shigella each year, particularly among children in LMICs. No approved Shigella vaccine is available outside of Russia or China, and the development of Shigella vaccines has been identified as a priority by the World Health Organization (WHO). In October 2024, the FDA granted Fast Track designation to S4V2, recognizing its potential to address a serious condition and fill an unmet medical need.
VLA1601 – a highly purified inactivated, adjuvanted vaccine candidate against the mosquito-borne viral disease caused by the Zika virus, or ZIKV. Disease outbreaks have been reported in tropical Africa, Southeast Asia, the Pacific Islands, and, since 2015, in the Americas. Zika virus transmission persists in several countries in the Americas and in other endemic regions. To date, a total of 89 countries and territories have reported evidence of mosquito-transmitted Zika virus infection; however, surveillance remains limited globally. There are no preventive vaccines or effective treatments available. As such, Zika remains a public health threat and is included in the FDA’s Tropical Disease Priority Review Voucher Program. VLA1601 is being developed on the original manufacturing platform of the company’s licensed Japanese encephalitis vaccine IXIARO, which was further optimized to develop the company’s inactivated, adjuvanted COVID-19 vaccine VLA2001, the first COVID-19 vaccine to receive a standard marketing authorization in Europe. The company reported positive Phase 1 results for the first generation of its Zika vaccine candidate in 2019, showing a favorable safety profile and immunogenicity in all tested doses and schedules, comparable to IXIARO and other clinical-stage ZIKV vaccines. In March 2024, the company initiated a Phase 1 clinical trial to investigate the safety and immunogenicity of its optimized vaccine candidate. The randomized, placebo-controlled, Phase 1 trial, VLA1601-102, is planned to enroll approximately 150 participants aged 18 to 49 years in the United States. A vaccine against the Zika virus would nicely complement Valneva’s portfolio of travel vaccines against mosquito-borne diseases, which already includes IXCHIQ and IXIARO.
In addition to the company’s clinical-stage assets, the company’s portfolio includes a series of pre-clinical assets against disease targets that reflect the company’s strategy of providing prophylactic solutions to significant diseases that lack a preventative and effective therapeutic treatment option. These include VLA2112, a vaccine candidate targeting the Epstein-Barr virus, or EBV, which is one of the most common human viruses. EBV can cause infectious mononucleosis and is strongly associated with the development of several types of cancer and multiple sclerosis. The company has also been working on a vaccine candidate targeting the enteric disease caused by Enterotoxigenic Escherichia coli (ETEC).
The company commercializes its fully owned travel vaccines IXIARO/JESPECT, DUKORAL, and IXCHIQ and previously supplied the company’s inactivated COVID-19 vaccine VLA2001 under government contracts.
IXIARO is an inactivated Vero cell culture-derived Japanese encephalitis vaccine that is the only Japanese encephalitis vaccine licensed and available in the United States, Canada, and Europe. IXIARO is indicated for active immunization against Japanese encephalitis, the most prevalent cause of viral encephalitis in Asia, for adults, adolescents, children, and infants aged two months and older. In 2024, Valneva supplied additional doses of IXIARO to the U.S. Department of Defense (DoD) under the contract it signed in September 2023, which allowed the DoD to purchase additional doses during the following twelve months.
DUKORAL is an oral vaccine for the prevention of diarrhea caused by Vibrio cholera and, in Canada and certain other countries, heat-labile toxin-producing ETEC, the leading cause of travelers’ diarrhea. DUKORAL sales benefited from the resumption of marketing investments in the second half of 2024 following the successful regulatory inspection of the company's new manufacturing site in Sweden. DUKORAL is authorized for use in the European Union and Australia to protect against cholera, and in Canada, Switzerland, New Zealand, and Thailand to protect against cholera and ETEC.
IXCHIQ is a single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. In 2024, the company received marketing approval for IXCHIQ in the United States, Europe, and Canada. With these approvals, IXCHIQ became the world’s first licensed chikungunya vaccine available to address this unmet medical need and the third vaccine Valneva brought from early R&D to approval. Valneva started commercializing IXCHIQ in the United States in the first quarter of 2024 and in Canada and France at the end of 2024.
Strategy
The company’s strategy supports its intention to contribute to a world in which no one dies or suffers from a vaccine preventable disease. The company’s strategy is based on an integrated business model that has allowed the company to build a portfolio of differentiated clinical and pre-clinical assets as well as a growing commercial business. The company is focused on utilizing its proven and validated product development capabilities to rapidly advance solutions addressing unmet needs in infectious diseases towards regulatory approval, with the intention of becoming first-, best-, or only-in-class. The company has entered into strategic partnerships with other well-established pharmaceutical companies to leverage their clinical and commercial capabilities to optimize the potential value of select assets. As the company advances its late stage portfolio, the company also remains focused on investing in its research and development pipeline in order to develop the company’s earlier stage assets, as well as identify new targets and indications where the company can make a significant difference.
VLA15— The Company’s vaccine candidate targeting Lyme disease
The company is developing VLA15 as an investigational vaccine against Borrelia, the bacterium that causes Lyme disease. VLA15 is a recombinant protein vaccine candidate that targets six serotypes of Borrelia, representing the most common serotypes found in North America and Europe. The company has reported initial results of three Phase 2 clinical trials of VLA15 in over 900 healthy adults, and the results have demonstrated the presence of high titers of antibodies against all six serotypes. n August 2022, together with Pfizer, the company initiated a Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR), to investigate the efficacy, safety, and immunogenicity of VLA15 in participants five years of age and older in highly endemic regions in the United States and Europe. In February 2023, the company announced that Pfizer, as the study sponsor, decided to discontinue approximately half of the total recruited participants in the trial following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator. The discontinuation of these participants was not due to any safety concerns with the investigational vaccine and was not prompted by a participant-reported adverse event. In December 2023, the company and Pfizer announced that they completed recruitment for the study. In July 2024, the company announced completion of the three-dose primary vaccination series. Participants are now receiving their booster dose and will be monitored for the occurrence of Lyme disease cases until the end of the Lyme disease season in 2025. Pfizer aims to submit a Biologics License Application (BLA) to the FDA and a marketing authorization application (MAA) to the EMA in 2026, subject to positive data. The company announced its collaboration with Pfizer for the late-phase development and commercialization of VLA15.
The company evaluated VLA15 in a partially randomized, multi-center dose escalation Phase 1 clinical trial conducted in Belgium and the United States in 179 healthy adults below 40 years of age. The company has evaluated the safety and immunogenicity of VLA15 at different dosage levels and schedules in three Phase 2 clinical trials in Europe and the United States.
VLA15-201 Clinical Trial
The company’s first Phase 2 clinical trial, VLA15-201, was a randomized, observer-blind, placebo-controlled, multi-center Phase 2 clinical trial conducted in Belgium, Germany, and the United States, consisting of a run-in phase and a main study phase. In the run-in phase, a total of 120 participants aged 18-40 were randomized into one of four groups: a placebo group and three groups at different dosage levels of VLA15 with alum (90 µg, 135 µg, or 180 µg). The primary endpoint for the trial was GMTs for IgG against each OspA serotype ST1 to ST6. Secondary endpoints examined SCR, geometric mean fold rise (GMFR), and the occurrence of adverse events.
In July 2020, the company announced results from its Phase 2 clinical trial of VLA15-201, in which it observed that VLA15 was immunogenic across all dose groups tested. Compared to results from the Phase 1 clinical trial, the higher doses used in the Phase 2 clinical trial elicited higher antibody responses across all serotypes than those observed after the primary series in the Phase 1 clinical trial. The seroconversion rates (SCR) in the highest dose ranged from 81.5% (ST1) to 95.8% (ST2) on Day 85. No statistically significant differences between the 135 µg and 180 µg treatment groups were observed.
VLA15-202 Clinical Trial
The company’s second Phase 2 clinical trial, VLA15-202, was a randomized, observer-blind, placebo-controlled multi-center Phase 2 clinical trial conducted in the United States with 246 healthy volunteers aged 18-65. The primary endpoint of the trial was GMTs for IgG against each OspA serotype, measured at month 7 to highlight the importance of further increases in OspA-specific IgG titers after the primary immunization series, which are likely necessary to achieve a successful vaccine candidate. Secondary endpoints evaluated SCRs, GMFRs, and the occurrence of adverse events. On October 20, 2020, the company reported interim results from VLA15-202. Compared to VLA15-201, immunogenicity was further enhanced using an immunization schedule of vaccinating at zero, two, and six months. SCRs, after completion of the primary vaccination series.
VLA15-221 Clinical Trial
VLA15-221 is a randomized, observer-blind, placebo-controlled Phase 2 clinical trial. The trial was conducted at sites in the U.S. located in areas where Lyme disease is endemic and has enrolled volunteers with a cleared past infection with Borrelia burgdorferi, as well as Borrelia burgdorferi-naïve volunteers. Participants received VLA15 at a dose of 180 µg, which was selected based on data generated in the two previous Phase 2 clinical trials.
In April 2022, together with Pfizer, the company reported positive pediatric data for the VLA15-221 trial. In pediatric participants (5-17 years old) who received VLA15 in either the two-dose schedule (N=93) or the three-dose schedule (N=97), VLA15 was found to be more immunogenic than in adults with both vaccination schedules tested. Additionally, in September 2023, the company reported positive booster results for this trial. In September 2024, the company and Pfizer reported further booster results following vaccination with a second booster dose given one year after receiving the first booster dose.
Phase 3 Trial
In August 2022, together with Pfizer, the company announced the initiation of a Phase 3 clinical trial, Vaccine Against Lyme for Outdoor Recreationists (VALOR), to investigate the efficacy, safety, and immunogenicity of VLA15. The randomized, placebo-controlled Phase 3 VALOR trial has been enrolling participants five years of age and older and is being conducted in areas where Lyme disease is highly endemic, including Finland, Germany, the Netherlands, Poland, Sweden, Canada, and the United States.
In December 2023, the company and Pfizer announced that they completed recruitment for the study. A total of 9,437 participants five years of age and older were enrolled to receive, as part of the full primary series, three doses of VLA15 at 180 µg or a saline placebo (1:1 ratio) within the first year, and one booster dose of VLA15 or saline placebo approximately one year after vaccination with the first three doses. In July 2024, the company announced completion of the three-dose primary vaccination series. Participants are continuing to receive their booster dose will be monitored for the occurrence of Lyme disease cases until the end of the Lyme disease season in 2025. Pfizer aims to submit a Biologics License Application (BLA) to the FDA and a marketing authorization application (MAA) to the EMA in 2026, subject to positive data.
VLA1553 / IXCHIQ—the company’s vaccine targeting the chikungunya virus
VLA1553 is a single-dose, live-attenuated vaccine candidate against CHIKV, which was approved under the brand name IXCHIQ in the United States, Canada, Europe, and the United Kingdom in November 2023, June 2024, July 2024, and February 2025, respectively. It is indicated for the prevention of disease caused by CHIKV in individuals 18 years of age and older. The vaccine is still undergoing several clinical trials with a view to expand access, support label extensions, and enhance the product profile.
In 2024, the company submitted label extensions to extend the use of IXCHIQ, which is currently approved in adults, to adolescents aged 12 to 17 years, in the U.S., Europe, and Canada. The Canadian and U.S. label extension applications also included two-year antibody persistence data, which is a key differentiator for IXCHIQ that was already included in the initial filing with the EMA. In February 2025, the EMA’s CHMP adopted a positive opinion recommending authorization of IXCHIQ’s label extension to adolescents. Additionally, the company initiated a Phase 2 pediatric trial in children 1 to 11 years of age, VLA1553-221, in January 2024 to support a Phase 3 pivotal pediatric study and potentially extend the label in this age group following initial regulatory approvals in adults and possibly in adolescents. In January 2025, the company announced positive results for VLA1553-221. The trial, which was evaluating the safety and immunogenicity of two different dose levels of IXCHIQ in 304 children, met its primary endpoint.
VLA1553 / IXCHIQ Approach
IXCHIQ is a live-attenuated chikungunya vaccine based on the East, Central, and Southern African, or ECSA, strain which has spread across the Indian Ocean. It is cross-reactive with other strains, meaning that it is designed to protect against those as well, including the strain of Asian lineage which is rapidly spreading across the Americas as observed in pre-clinical studies. Additionally, given that the company has engineered IXCHIQ as a live-attenuated vaccine, it may confer life-long immunity.
IXCHIQ is engineered using a strain of chikungunya, where specific segments of the virus have been deleted, thereby weakening, or attenuating, the virus. This approach enables IXCHIQ to catalyze the patient’s immune system into generating the antibodies necessary to provide protection against the virus while the weakened strain does not cause the patient to develop significant symptoms. In the company’s pre-clinical studies, growth of this strain on Vero cells resulted in a viral titer 35 times lower than observed with the original unattenuated strain, demonstrating the attenuation of the company’s chikungunya strain. The deleted segment also remained absent following replication of the virus in the Vero cells, suggesting that the weakness of the virus is sustained.
Phase 1 Clinical Trial and Results
The company conducted a single-blind, randomized dose-escalation Phase 1 clinical trial of VLA1553 in 120 adults at multiple centers in the United States, the results of which were published in the Lancet Infectious Diseases in 2020. Chikungunya virus neutralizing antibodies were observed in 100% of patients for 12 months at all three of the doses evaluated. A single vaccination was sufficient to induce sustaining high-titer neutralizing antibodies at 12 months post-vaccination. The company found that 100% of participants had seroconverted by day 14 at all three of the doses tested, and this seroconversion persisted for one year across all dose groups. When re-evaluated with the assay that was used to define the seroresponse threshold for Phase 3, the company confirmed that 100% of participants had seroresponded by day 14.
Phase 3 Clinical Trials
VLA1553-301 Clinical Trial
In September 2020, the company initiated its pivotal Phase 3 clinical trial, VLA1553-301, in the United States. In this double-blind, multi-center, randomized Phase 3 clinical trial, 4,115 participants aged 18 years and above were randomized 3:1 into two groups to receive either VLA1553 0.5 mL or a placebo. Immunogenicity was determined with a µPRNT50 assay. The final pivotal Phase 3 data were published in The Lancet in June 2023.
VLA1553-302 Clinical Trial
The company also initiated a lot-to-lot consistency Phase 3 trial, VLA1553-302, in February 2021 to demonstrate the manufacturing consistency of VLA1553, which is a requirement for licensure. The company announced completion of recruitment for this trial in June 2021 and positive topline and final data from this trial in December 2021 and May 2022, respectively. The lot-to-lot data were part of the company's submission to the FDA, which was completed in December 2022.
VLA1553-303 Clinical Trial
In April 2021, the company initiated an antibody persistence trial that will follow annually up to 375 subjects in the immunogenicity subset of the VLA1553-301 trial for a period of ten years after a single immunization with IXCHIQ. In December 2022, 2023, and 2024, the company reported 12-, 24-, and 36-month data, respectively, for this trial. Twelve, 24, and 36 months after the single-dose vaccination, 99%, 97%, and 96% of participants, respectively, retained neutralizing antibody titers above the seroresponse threshold of 150.
VLA1553-321 Clinical Trial
In January 2022, the company announced the initiation of a Phase 3 trial of VLA1553 in 754 adolescents aged 12 to 17 years. Conducted in Brazil by the Instituto Butantan and funded by CEPI, the VLA1553-321 trial is intended to support the label extension in this age group following the initial regulatory approval in adults from the FDA. This trial is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in endemic populations.
In November 2023, the company reported positive Phase 3 immunogenicity and safety data showing that a single-dose vaccination with VLA1553 induced a robust immune response in adolescents, thereby confirming the excellent immunogenicity previously observed in adults. VLA1553 induced levels of protective antibody titers in 98.8% of participants 28 days after a single vaccination, significantly exceeding the FDA’s requirement for study success of the lower bound of the 95% confidence interval (CI) for seroresponse rate >70%. Additionally, VLA1553 was generally well tolerated in adolescents, irrespective of previous CHIKV infection, and showed a similar safety profile as reported in adults. In May 2024, the company reported six-month data that confirmed the positive immunogenicity and safety data reported previously. A single-dose vaccination with VLA1553 induced a high, sustained immune response with a seroresponse rate of 99.1% (232 out of 234 participants) at Day 180 in an immunogenicity subset of individuals who were CHIKV negative at baseline. Additionally, the six-month data confirmed that a single dose of the vaccine was generally safe and well tolerated in adolescents receiving VLA1553, irrespective of previous infection with the chikungunya virus. Throughout the trial, an independent Data Safety Monitoring Board (DSMB) consistently assessed safety data and found no safety issues. The majority of solicited adverse events observed following VLA1553 administration were mild or moderate and resolved within three days post-vaccination. In January 2025, the company reported positive twelve-month Phase 3 data, which showed a sustained seroresponse rate in 98.3% of adolescents one year after single vaccination. These results support and strengthen the pivotal data previously reported for adolescents (12 to 17 years old), which supported filing for potential label extension to this age group in the U.S., Europe, and Canada. Data from this trial are also expected to support licensure of IXCHIQ in Brazil, which would be the first potential approval for use in endemic populations.
VLA1553-221 Clinical Trial
In January 2024, the company initiated a Phase 2 pediatric trial in children one to eleven years of age to evaluate the safety and immunogenicity of two different dose levels of IXCHIQ. The multicenter, prospective, randomized, observer-blinded Phase 2 clinical trial enrolled 304 healthy children at three trial sites in the Dominican Republic and Honduras. Following a safety run-in phase, participants were randomized to receive either a full dose formulation of the vaccine (120 participants), a half dose formulation (120 participants), or a control vaccine (60 participants). In January 2025, the company announced positive results for VLA1553-221.
S4V2— The most advanced tetravlent Shigellosis vaccine candidate
In August 2024, the company entered into a collaboration with LimmaTech Biologics AG for the development of S4V2, a tetravalent bioconjugate vaccine candidate against shigellosis, a diarrheal infection caused by Shigella bacteria. In October 2024, the U.S. FDA granted Fast Track designation to S4V2, recognizing its potential to address a serious condition and fill an unmet medical need.
In November 2024, the company and LimmaTech announced the launch of a parallel-group, randomized, double-blind, multicenter, placebo-controlled Phase 2b controlled human infection model (CHIM) study to assess the safety, immunogenicity, and preliminary efficacy in approximately 120 healthy Shigella-naïve participants aged 18 to 50 years at three sites in the United States. In addition to the CHIM study, LimmaTech is preparing for a Phase 2 pediatric safety and immunogenicity study in low- and middle-income countries.
The company’s other clinical programs
VLA1601—the company’s Zika virus development program
Zika is a mosquito-borne viral disease caused by the Zika virus (ZIKV). It is the first and only flaviviral disease that was declared a public health emergency because of devastating birth defects following maternal infection. According to the World Health Organization, there is scientific consensus that Zika virus is a cause of microcephaly and Guillain-Barré syndrome.
VLA1601 is a highly purified inactivated, adjuvanted vaccine candidate against the Zika virus. It is being developed on the original manufacturing platform of Valneva’s licensed Japanese encephalitis vaccine IXIARO, which was further optimized to develop the company’s inactivated, adjuvanted COVID-19 vaccine VLA2001, the first one to receive standard marketing authorization in Europe. Valneva reported Phase 1 results from its first-generation Zika vaccine candidate in 2019. The inactivated vaccine candidate met the study’s primary endpoint, showing a favorable safety profile in all doses and schedules tested, comparable to IXIARO and other clinical-stage ZIKV vaccines.
VLA84—The company’s Clostridium difficile vaccine candidate that remains on hold
The company has developed VLA84, a vaccine candidate targeting the prevention of primary symptomatic Clostridium difficile infection, or CDI, a leading cause of life-threatening, healthcare-associated infections worldwide. VLA84 is designed to produce an immune response to neutralize the effects of C. difficile toxins A and B, which are considered to be largely responsible for CDI. The company completed Phase 2 development of VLA84. The key objectives of the Phase 2 trial were met, as the vaccine candidate generated strong immune responses against C. difficile toxins A and B, and the safety and tolerability profile was good. The company could advance into Phase 3 if it finds a suitable partner to reactivate this program.
Pre-clinical Portfolio
In addition to the company’s clinical-stage assets, the company’s portfolio includes several pre-clinical assets against disease targets that reflect the company’s strategy of providing prophylactic solutions to significant diseases that lack a preventative and effective therapeutic treatment option.
The company’s pre-clinical work involves exploratory study of a given disease, including extensive review of existing literature and early data that will inform the company’s view of whether and how the company could develop a vaccine for that disease.
The company's two most advanced pre-clinical assets against EBV and Enterotoxigenic Escherichia coli (ETEC) are presented. Additionally, the company has initiated pre-clinical work on vaccine candidates against different enteric diseases.
VLA2112 – The company’s vaccine candidate targeting Epstein-Barr Virus (EBV)
Epstein-Barr virus (EBV), also known as human herpesvirus 4, is a member of the herpes virus family. It is found all over the world and is one of the most common human viruses. Most people get infected with EBV by early adulthood. EBV spreads most commonly through bodily fluids, primarily saliva. EBV can cause infectious mononucleosis, also called mono, and is strongly associated with different cancers and multiple sclerosis.
The company's EBV vaccine candidate, VLA2112, is based on adjuvanted, subunit viral glycoproteins to elicit high titers of EBV-neutralizing antibodies. The selection of antigens that best neutralize infection of both epithelial cells and B cells was completed in 2023, and confirmatory preclinical research is ongoing.
The company’s vaccine candidate targeting Enterotoxigenic Escherichia Coli (ETEC)
The company has started research work on a vaccine candidate against ETEC. Antigen selection is ongoing for the candidate, which the company expects to be highly differentiated compared to other existing ETEC vaccine candidates. ETEC is the most common cause of traveler’s diarrhea and a major cause of diarrhea in children in LMICs.
Commercial Portfolio
The company’s commercial portfolio is composed of three vaccines, the company’s travel vaccines IXIARO/JESPECT, DUKORAL, and IXCHIQ. The company stopped manufacturing its inactivated COVID-19 vaccine, VLA2001, in August 2022 in light of reduced order volumes. The company’s travel vaccines serve a wide range of potential travelers where the diseases they prevent are endemic, from business and leisure travelers to government and military personnel traveling on behalf of their government. The company also distributes certain third-party vaccines in countries where the company operates its own marketing and sales infrastructure. The company’s commercial activities have generated meaningful revenues, much of which the company has reinvested in its research and development capabilities in order to advance the company’s clinical assets and drive future growth.
IXIARO
IXIARO, or JESPECT in Australia and New Zealand, is an inactivated Vero cell culture-derived Japanese encephalitis vaccine and is the only Japanese encephalitis vaccine approved for use in the United States, Canada, and Europe. IXIARO is indicated for active immunization against Japanese encephalitis in adults, adolescents, children, and infants aged two months and older, and is a required vaccine for the U.S. military personnel who are deployed to areas of risk for Japanese encephalitis. The pediatric indication of IXIARO was granted Orphan Drug designation by the FDA.
IXIARO
IXIARO is an inactivated vaccine administered as two doses either seven or 28 days apart. In a randomized clinical trial, high titers of neutralizing antibodies were detected in 96.4% of adults 28 days after the last dose. The immune response to IXIARO was durable, with high levels of neutralizing antibodies in 84.9% of participants three years after initial immunization. A separate trial administration of a booster dose at 14 months after completion of the initial two doses resulted in 100% of participants having neutralizing antibodies.
IXIARO is approved for the prevention of disease caused by JEV in individuals two months of age and older. This intramuscular vaccine is administered in two parts, between seven and 28 days apart depending on the age of the recipient, and with the second dose completed at least a week prior to potential exposure to JEV. A booster shot may be given at least 11 months after completion of the primary immunization series if ongoing exposure or re-exposure to JEV is expected. In 2020, the FDA approved the extension of IXIARO’s shelf life from 24 months to 36 months.
DUKORAL
DUKORAL is an oral vaccine containing four inactivated strains of the bacterium Vibrio cholerae serotype O1, and part of a toxin from one of these strains as active substances. DUKORAL is authorized for use in the European Union and Australia to protect against cholera and in Canada, Switzerland, New Zealand, and Thailand to protect against cholera and ETEC, the leading cause of travelers’ diarrhea. Originally licensed in Sweden by SBL Vaccines in 1991, and subsequently in the European Union in 2004 through a centralized procedure followed by other international markets, the vaccine was acquired by the company in 2015 from Janssen Pharmaceuticals as part of the company’s strategic vision to extend the company’s proprietary travel vaccine portfolio.
DUKORAL Overview
DUKORAL is intended for active immunization against cholera (and LT-ETEC diarrhea in certain jurisdictions) in adults and children from two years of age who will be visiting endemic/epidemic areas. The use of DUKORAL should be determined on the basis of official recommendations, taking into account the variability of epidemiology and the risk of contracting disease in different geographical areas and travelling conditions. DUKORAL is a drinkable vaccine that helps prevent diarrhea caused by heat-labile toxin-producing ETEC, as well as cholera.
DUKORAL is administered orally after dissolving the product in a glass of water. Vaccination requires two doses given one to six weeks apart. In an efficacy trial done in Bangladesh in 89,596 adults and children aged two years and older, the efficacy of DUKORAL against cholera was 85% in the six months after the third dose and 57% in the second year after immunization. Protective efficacy declined over the three-year trial period. DUKORAL conferred 67% protection against episodes of diarrhea caused by ETEC during the initial three months of follow-up but demonstrated no protection thereafter.
IXCHIQ—The Company’s Chikungunya Vaccine
IXCHIQ is the world’s first licensed chikungunya vaccine available to address this unmet medical need and the third vaccine the company brought from early R&D to approval. The company received marketing approval for IXCHIQ from the FDA in November 2023 under an accelerated pathway based on anti-CHIKV neutralizing antibody titers. Continued approval for this indication is contingent upon verification of clinical benefit in Phase 4 confirmatory studies. IXCHIQ is also approved in Canada, Europe, and the United Kingdom.
IXCHIQ Overview
IXCHIQ is a single-dose, live-attenuated vaccine licensed in the U.S., Europe, Canada, and the UK. It is indicated for the prevention of disease caused by chikungunya virus in individuals 18 years of age and older. At the end of February 2024, the ACIP provided recommendations on how to use IXCHIQ, and these recommendations were then adopted by the CDC. The company expects expanded access to the retail channel via publication of the ACIP recommendations in the Morbidity and Mortality Weekly Report (MMWR). A marketing authorization application is also under review in Brazil, which would represent the first approval in an endemic country.
The company submitted label extension applications to potentially extend the use of IXCHIQ, which is approved in adults, to adolescents aged 12 to 17 years, in the U.S., Europe, and Canada. The Canadian and U.S. label extension applications also include two-year antibody persistence data, which is a key differentiator for IXCHIQ that was already included in the initial filing with the EMA. In February 2025, the EMA’s CHMP adopted a positive opinion recommending authorization of a label extension for IXCHIQ to adolescents. The EC will review the CHMP recommendation, and a decision on the label extension in the EU, Norway, Liechtenstein, and Iceland is expected within sixty days following the CHMP’s positive opinion.
Third-party Vaccines
The company distributes certain third-party vaccines in countries where it operates its own marketing and sales infrastructure. In June 2020, the company entered into a distribution agreement with Bavarian Nordic, pursuant to which it agreed to commercialize their marketed vaccines for rabies and tick-borne encephalitis, leveraging its commercial infrastructure in Canada, the United Kingdom, France, and Austria during the COVID-19 outbreak. The agreements relating to the company's distribution of Bavarian Nordic’s rabies vaccine in Canada and the United Kingdom terminated on December 31, 2024, and the remaining distribution agreements between the company and Bavarian Nordic will terminate on December 31, 2025. In September 2022, the company also announced a partnership with VBI Vaccines for the marketing and distribution of the only 3-antigen Hepatitis B vaccine, PreHevbri, in select European markets. This contract ended in 2024 when VBI voluntarily withdrew PreHevbri from the markets following insolvency proceedings.
Sales and Marketing
The company has a specialist commercial capability comprising approximately 52 employees for the distribution of the company’s travelers’ vaccines, IXIARO and DUKORAL, and third-party vaccines.
The company has established its own commercial operations in certain travel vaccine markets including the United States, Canada, the United Kingdom, Sweden, France, Austria, Norway, Denmark, Finland, Belgium, and the Netherlands. The company commercializes its own and third-party vaccine brands to both private and government customers, including the U.S. military. In other markets, the company has entered into marketing and distribution agreements with companies that specialize in the promotion of travel brands and/or for which there is a strategic fit with their product portfolio. Examples of such distribution partnerships include Germany (Bavarian Nordic), Eastern Europe (IMED), Israel (Kamada), and Australia and New Zealand (Seqirus/CSL).
Commercial Operations in Key Markets
The company manages nearly all of its global product sales revenues through the company’s own commercial operations. Local operations include expertise in Sales, Marketing, Medical Affairs, Governmental Affairs (U.S.), business support functions, and General Management.
The company’s commercial teams work continuously to improve service and performance, including embracing digital technology, which allows the company to better connect with travelers, physicians, and other health care professionals. The company puts the customer at the heart of its activities and focuses on their needs for improved awareness, a deeper understanding of the travel health landscape, and tailor-made services to achieve their objectives.
The company has also continued to leverage its commercial organization to distribute third-party products and aims to attract additional products to further utilize its commercial infrastructure. The company entered into a partnership with Seqirus in 2016 to commercialize two differentiated flu vaccines in Austria. It also entered into a marketing and distribution partnership with Kamada in 2018 to commercialize their rabies immunoglobulin in Canada and with Bavarian Nordic in 2020 to commercialize their Rabipur and Encepur brands in Austria, the UK, France, Belgium, the Netherlands, and Canada. In September 2022, the company announced a marketing and distribution agreement with VBI Vaccines Inc. to commercialize their Hepatitis B vaccine PreHevbri in the United Kingdom, Sweden, Norway, Denmark, Finland, Belgium, and the Netherlands, which ended in 2024.
Intellectual Property
Patents and Patent Applications
As of December 31, 2024, the company had a portfolio of 448 issued patents, including 83 granted with effect in Germany, France, the United Kingdom, Spain, and Italy, 50 issued in the United States, and 158 pending patent applications, including 24 pending in Europe and four pending international, or PCT, patent applications.
In countries where the company seeks legal protection through patents, the duration of legal protection for a particular product, method, or use is generally 20 years from the filing date. This protection may be extended in some countries, particularly in the European Union, China, Japan, South Korea, Australia, Canada, and the United States. The protection, which may also vary by country, depends on the type of patent and its scope. In most industrialized countries, any new active substance, formulation, indication, or manufacturing process may be legally protected. The company conducts ongoing checks to protect the company’s inventions and to act against any infringement of the company’s patents.
IXIARO
In regards to the company’s Japanese encephalitis vaccine, IXIARO, as of December 31, 2023, the company owned a patent family that includes five issued U.S. patents (9,884,115; 9,895,437; 9,913,898; 10,668,146; and 11,110,170) with claims covering the aqueous composition of IXIARO and methods for preparing IXIARO, and one pending U.S. patent application. This patent family also includes two granted European patents with claims directed to compositions comprising IXIARO and/or methods for preparing IXIARO, and one pending European patent application. One of the granted European patents directed to a method for preparing an aqueous composition comprising aluminium, a reactive compound and a protein, was opposed at the EPO in June 2023. Patent applications, if issued, and patents in this family are expected to expire in 2032, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
The company also owns a pending U.S. and a European patent application with claims covering the manufacturing processes of IXIARO and potentially other vaccines. Patent applications, if issued, are expected to expire in 2040, without giving effect to any potential patent term extensions and patent term adjustments and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
Valneva also owns a pending U.S., Canadian, and European patent application with claims covering a particular use of the IXIARO formulation and potentially other vaccines. If issued, the patent application is expected to expire in 2041, without giving effect to any potential patent term extensions and patent term adjustments, and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
DUKORAL
Regarding the company's DUKORAL product, as of December 31, 2024, it owns a pending U.S., Canadian, and European patent application with claims directed to stable pharmaceutical compositions covering a non-commercialized formulation of DUKORAL and methods of use thereof. If issued, the patent applications or applications related to these applications are expected to expire in 2041, without giving effect to any potential patent term extensions and patent term adjustments, and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. Patents covering the composition of matter of DUKORAL are expired.
VLA15—Borrelia vaccine candidate
Regarding the company's Borrelia vaccine candidate VLA15, which is currently licensed to Pfizer, as of December 31, 2024, the company owns a patent family that includes six issued U.S. patents, two pending U.S. patent applications, and two European patents that are validated—one in 38 of the European Patent Convention member states and the other in 12 of those member states—as well as 26 foreign patents and two patent applications with claims covering the composition of matter of VLA15. The company further owns a second patent family that includes three issued U.S. patents and one granted European patent, as well as 16 foreign patents and six patent applications with claims covering the composition of matter of VLA15. If issued, patent applications and patents in these families are expected to expire in 2033 and 2035, without giving effect to any potential patent term extensions and patent term adjustments, and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. The company also owns a patent family with claims directed to immunogenic polypeptides with C-terminus domains of OspA to induce a protective immune response. This includes a U.S. patent, and a European patent validated as a Unitary patent, a UK patent, and a Spanish patent, along with patent applications pending in the U.S., Canada, and Hong Kong. If issued, patent applications in this family are expected to expire in 2038, without giving effect to any potential patent term extensions and patent term adjustments, and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
As of December 31, 2024, the company also owns two patent families with claims directed to compositions comprising OspA fusion proteins, including uses thereof, and improved methods for producing a vaccine. Both families were nationalized in Europe, the U.S., and Canada in 2022. If issued, patent applications claiming priority to these patent applications are expected to expire in 2041, without giving effect to any potential patent term extensions and patent term adjustments, and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
Additionally, the company co-owns with a third party a patent family that includes pending patent applications in Europe, the U.S., and 13 further foreign jurisdictions. If issued, patent applications claiming priority to these patent applications are expected to expire in 2041, without giving effect to any potential patent term extensions and patent term adjustments, and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
The company also owns a European patent directed to an aqueous composition comprising aluminum, a reactive compound, and a protein. This case has been opposed at the EPO in January 2025.
IXCHIQ
Regarding the company's IXCHIQ product, as of December 31, 2024, it owns two patent families that include four granted U.S. patents and two granted European patents with claims covering methods of preparing and purifying VLA1553, along with two pending European patent applications and one U.S. patent application. If issued, patent applications and patents in this family are expected to expire in 2036, without giving effect to any potential patent term extensions and patent term adjustments, and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
The company also owns a patent family with claims directed to pharmaceutical compositions of VLA1553, which includes three U.S. patents, two New Zealand patents, and patents in Brazil, China, Japan, Mexico, and Taiwan, along with over 20 pending patent applications in jurisdictions such as the U.S., Europe, Australia, Brazil, Canada, China, India, Japan, and Mexico. If issued, patent applications and patents in this family are expected to expire in 2038, without giving effect to any potential patent term extensions and patent term adjustments, and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
As of December 31, 2024, the company also owns two patent families with claims covering formulations, secondary uses, and manufacturing processes of VLA1553. Each of these two families has been nationalized in 17 jurisdictions, and all are still pending except in South Africa. If issued, patent applications in these families are expected to expire in 2040, without giving effect to any potential patent term extensions and patent term adjustments, and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
The company also owns three patent families with claims directed to the administration of IXCHIQ in immunocompromised subjects, and two directed to particular formulations and combination uses. As of December 31, 2024, these families are either in the priority year or have been recently filed as international patent applications, but none of the three families are published yet. If issued, patent applications in these families are expected to expire in 2044 or 2045, without giving effect to any potential patent term extensions and patent term adjustments, and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
VLA2401—Shigella Vaccine Candidate
Regarding the company's Shigella vaccine VLA2401, as of December 31, 2024, it has in-licensed twelve patent families, most of which are related to a bioconjugation technology using mutated PglB oligosaccharyltransferases and its uses to produce vaccine candidates, including the vaccine candidate VLA2401. The latest of these patents, which relates to an immunogenic composition of VLA2401, if maintained, is expected to expire in 2041, without giving effect to any potential patent term extensions and patent term adjustments, and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
VLA84—Clostridium difficile candidate
Regarding the company's C. difficile candidate VLA84, as of December 31, 2024, it owns a patent family with five granted U.S. patents that cover the composition of matter of VLA84 and methods of use thereof, one pending U.S. patent application, and 12 granted foreign patents in jurisdictions, such as Australia, China, and Japan. This patent family also includes a granted European patent validated in over 35 countries that has been opposed but is maintained by the European Patent Office in amended form, which still covers VLA84. A second European patent has not been opposed, and a third European patent application is pending. If issued, patent applications and patents in this family are expected to expire in 2031, without giving effect to any potential patent term extensions and patent term adjustments, and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
The company also filed an opposition against two European patents owned by a third party that have claims that might cover its C. difficile vaccine candidate. The European Patent Office revoked both of these patents in opposition proceedings, and after the patentee withdrew both appeals, they were canceled without substantive decisions.
Additionally, the company filed a further opposition against a European patent that has claims that might cover VLA84 in July of 2024. The European Patent Office has revoked this patent in the meantime.
VLA1601—Zika vaccine candidate
Regarding the company's Zika vaccine candidate VLA1601, as of December 31, 2024, it owns a patent family that includes five issued U.S. patents with claims covering the aqueous composition of VLA1601 and methods for preparing IXIARO, along with one pending U.S. patent application. This patent family also includes two granted European patents with claims directed to compositions comprising VLA1601 and/or methods for preparing VLA1601, as well as one pending European patent application. One of the granted European patents, directed to a method for preparing an aqueous composition comprising aluminum, a reactive compound, and a protein, was opposed at the EPO in June 2023. A second granted European patent, directed to an aqueous composition comprising aluminum, a reactive compound, and a protein, was opposed at the EPO in January 2025. If issued, patent applications and patents in this family are expected to expire in 2032, without giving effect to any potential patent term extensions and patent term adjustments, and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
Furthermore, the company owns a patent family with five granted U.S. patents that cover the formulation VLA1601, one pending U.S. patent application, one granted European patent validated in thirty countries, one pending European patent application, seven additional foreign patents, and ten further pending foreign patent applications. The granted European patent directed to a Zika virus vaccine was opposed at the EPO in November 2023. If issued, patent applications and patents in this family are expected to expire in 2036, without giving effect to any potential patent term extensions and patent term adjustments, and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. A third party has filed an Inter Partes Review Proceeding against one of the U.S. patents, for which the U.S. Patent Trial and Appeal Board has issued a decision denying institution after the company withdrew some of the claims.
The company also owns two patent families that include three granted U.S. patents with claims covering methods of preparing and purifying VLA1601, one pending U.S. patent application, and two granted and two pending European patent applications. If issued, patent applications and patents in these families are expected to expire in 2036, without giving effect to any potential patent term extensions and patent term adjustments, and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
The company also owns a pending U.S. patent application and a European patent application with claims covering the manufacturing processes of VLA1601 and potentially other vaccines. If issued, these patent applications are expected to expire in 2040, without giving effect to any potential patent term extensions and patent term adjustments, and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
Additionally, the company owns a patent family with claims directed to large-scale manufacturing processes of VLA1601. As of December 31, 2024, this family is still in the international patent application phase. If issued, patent applications in this family are expected to expire in 2044, without giving effect to any potential patent term extensions and patent term adjustments, and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
The company also has a patent family with claims directed to a second-generation Zika vaccine, including VLA1601. As of December 31, 2024, this family is still in the international patent application phase. If issued, patent applications in this family are expected to expire in 2044, without giving effect to any potential patent term extensions and patent term adjustments, and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
Trademarks
‘VALNEVA’ Trademark
Valneva SE and the company KRKA, tovarna zdravil, d.d., Novo Mesto signed a co-existence agreement on January 20, 2014, with respect to KRKA’s earlier trademark DALNEVA covering goods of Class 5. The company agreed on restricting the specification of goods for the trademark Valneva, by adding the limitation ‘none of the afore-mentioned goods for the treatment of cardiovascular diseases’ to the European Union Trademark (EUTM) application No. 011441268, and to any future applications.
Moreover, the company also filed a notice of opposition before the European Union Intellectual Property Office, or EUIPO, against the trademark application VALNECOR (application No. 13.519889) of the company Vetpharma Animal Health S.L., for Class 5, invoking articles 8(1)b and 8(4) of the Regulation (EC) No. 207/2009 on the Community trademark (EUTMR—as amended). On February 19, 2016, the Opposition Division of the EUIPO decided in the company’s favor and upheld the opposition (No. B 2508755) for all the contested goods in Class 5.
A letter of undertakings effective as of July 25, 2016 has been signed by VALNEVA, a French Simplified Joint Stock company, and Valneva SE, in order to acknowledge the company’s prior rights; and record VALNEVA’s undertaking never to contest or challenge the company name and the trademarks Valneva—registered or filed—for any goods and services.
VALNEVA further agreed not to use the name VALNEVA for scientific R&D in the fields of medicine, antibodies and vaccines.
The company and Boehringer Ingelheim International GmbH also signed a prior rights agreement on July 28, 2016. In this agreement, the company undertake not to use the trademark Valneva as a product name or part of a product name for the identification of specific products, but only to identify the fabricant of the product (‘house mark’ or ‘manufacturers brand’). The company also undertakes to limit the registration of the mark ‘Valneva’ in Class 5 to the ‘Pharmaceutical products for human and veterinary use, namely vaccines and antibodies and fragments thereof, blood serum, adjuvants for medical or veterinary use’, only if so specifically requested by Boehringer Ingelheim.
The company filed a notice of opposition before EUIPO against the trademark application VALNOBI n°17579525 made in Class 5 in the name of Bayer AG. On February 4, 2019, the Opposition Division of the EUIPO decided in the company’s favor and upheld the opposition (No. B 3 047 941) for all the contested goods in Class 5.
The company filed notices of opposition against the EU trademark application VALENA no. 017895207 and the Austrian trademark application VALENA no. 295810. The Austrian trademark application was withdrawn and the EU trademark application was rejected to a large part of the contested goods and services, and in particular to all of the goods in class 5.
‘IXIARO’ Trademark
On October 30, 2015, Valneva Austria GmbH acquired from GSK (GlaxoSmithKline Biologics SA, GlaxoSmithKline GmbH and CO.KG) the trademark ‘IXIARO’ and the related trademarks and domain names, for all jurisdictions. No co-existence or prior rights agreements exist for the trademark IXIARO.
OxARO v IXIARO
The company filed an Opposition in 2021 and signed a prior rights agreement with the result that SafeRx withdrew the application OxARO in the U.S. The Settlement Agreement was signed on January 26, 2022. According to the Settlement Agreement SafeRx undertakes to refrain from asserting rights deriving from U.S. Application Serial No. 90/233,007 or use of the trademark OXARO for pharmaceutical preparations and agrees to expressly abandon U.S. Application Serial No. 90/233,007. SafeRx agrees never to use OXARO by itself on a product distributed in the marketplace and will instead use ‘OxARO ER’ and ‘OxARO IR’. SafeRx may use OXARO solely for fundraising for product development and FDA review, but once through FDA review, SafeRx agrees never to use the mark OXARO by itself, but instead will use the marks ‘OxARO ER’ and ‘OxARO IR’.
‘DUKORAL’ Trademark
Various prior rights agreements related to the trademark ‘DUKORAL’ were executed in the years 1996 to 2002. A further prior rights and delimitation agreement between Crucell Sweden AB, Valneva Sweden AB, and Berlin-Chemie AG was signed on June 29, 2012. For mutual settlement of the opposition filed by then Crucell Sweden AB, Berlin Chemie AG undertakes not to derive any rights from the registration and use of their German trademark DUCORA against the Community Trademark registration of DUKORAL, and to tolerate new applications and modifications of the prior DUKORAL trademark, provided that Crucell Sweden AB shall not apply for the trademark DUCORA. Berlin-Chemie AG restricted the goods and services of their German registration of DUCORA. Crucell then agreed to the registration or use of German trademark DUCORAL under the conditions specified and to withdraw the opposition.
Domain Names
As of December 31, 2024, the company held 199 domain names (reserved or in the process of being reserved).
Government Regulation
The company’s operations are subject to regulation by various federal, state, and local authorities in addition to the FDA, including but not limited to the Centers for Medicare & Medicaid Services, or CMS, the Department of Health and Human Services, or HHS, (including the Office of Inspector General, Office for Civil Rights and the Health Resources and Services Administration), the U.S. Department of Justice, or DOJ, and individual U.S. Attorney offices within the DOJ, and state and local governments.
The company owns two neighboring facilities in Livingston, Scotland, that operate under a Manufacturer's License from the MHRA.
The company’s Solna facility can operate on a multi-product basis and comprises approximately 11,000 square meters. The site is qualified to meet required standards of several regulatory bodies including the competent Swedish authorities, Health Canada and TGA.
The company’s Solna site is operated on a long-term lease under a Manufacturers License from MPA.
The company’s facility in Vienna includes a dedicated Quality unit for Quality control (in vitro and in vivo) and Quality Assurance. This unit covers both proprietary and third party products. As such, this facility is registered with the FDA and operated under respective licenses from the Austrian Agency for Health and Food Safety. In Vienna, where the company has centralized its product development capabilities the company also has a GMP technical development unit that establishes the company’s new vaccines prior to the final industrialization stage.
Research and Development
The company’s research and development expenses were €74.1 million for the year ended December 31, 2024.
History
Valneva SE was founded in 1998. The company was incorporated in France in 1999.
Valneva Questions and Answers
Which sectors generate sales and which are the top 3 markets?
**Pharmaceutical Sales:** 100% (2026)
**TOP 3 Markets:**
1. **Europe:** 45%
2. **North America:** 30%
3. **Asia-Pacific:** 15%
Valneva SE generates its sales entirely from the pharmaceutical industry, particularly through the development and sale of vaccines. The European market is the largest rev...
**Pharmaceutical Sales:** 100% (2026)
**TOP 3 Markets:**
1. **Europe:** 45%
2. **North America:** 30%
3. **Asia-Pacific:** 15%
Valneva SE generates its sales entirely from the pharmaceutical industry, particularly through the development and sale of vaccines. The European market is the largest revenue contributor, followed by North America and the Asia-Pacific region. These markets are crucial for the company as they have a high demand for vaccines, especially in times of increased health risks.
**TOP 3 Markets:**
1. **Europe:** 45%
2. **North America:** 30%
3. **Asia-Pacific:** 15%
Valneva SE generates its sales entirely from the pharmaceutical industry, particularly through the development and sale of vaccines. The European market is the largest revenue contributor, followed by North America and the Asia-Pacific region. These markets are crucial for the company as they have a high demand for vaccines, especially in times of increased health risks.
At which locations are the company’s products manufactured?
**Production sites of Valneva SE:**
1. **Scotland (Livingston)**
2. **Austria (Vienna)**
3. **Sweden (Solna)**
Valneva SE is a specialized vaccine company that has strategically placed its production facilities in Europe. In Livingston, Scotland, one of the main production sites is located, which...
**Production sites of Valneva SE:**
1. **Scotland (Livingston)**
2. **Austria (Vienna)**
3. **Sweden (Solna)**
Valneva SE is a specialized vaccine company that has strategically placed its production facilities in Europe. In Livingston, Scotland, one of the main production sites is located, which is used for manufacturing vaccines against various infectious diseases. In Vienna, Austria, Valneva operates another significant production facility. Additionally, there is a production site in Solna, Sweden, which also contributes to the manufacturing and development of vaccines.
These sites enable Valneva to ensure efficient production and distribution of their products to serve the European and global markets.
1. **Scotland (Livingston)**
2. **Austria (Vienna)**
3. **Sweden (Solna)**
Valneva SE is a specialized vaccine company that has strategically placed its production facilities in Europe. In Livingston, Scotland, one of the main production sites is located, which is used for manufacturing vaccines against various infectious diseases. In Vienna, Austria, Valneva operates another significant production facility. Additionally, there is a production site in Solna, Sweden, which also contributes to the manufacturing and development of vaccines.
These sites enable Valneva to ensure efficient production and distribution of their products to serve the European and global markets.
What strategy does Valneva pursue for future growth?
**Revenue Growth:** 18% (2025)
**R&D Investments:** 25% of revenue (2025)
Valneva SE pursues a growth strategy that is heavily focused on research and development (R&D). The company invests significant resources in developing new vaccines to expand its product pipeline and respond to future...
**Revenue Growth:** 18% (2025)
**R&D Investments:** 25% of revenue (2025)
Valneva SE pursues a growth strategy that is heavily focused on research and development (R&D). The company invests significant resources in developing new vaccines to expand its product pipeline and respond to future healthcare needs.
Another focus is on geographical expansion, particularly in markets with high growth potential. Valneva plans to strengthen its presence in Asia and North America to benefit from the increasing demand for vaccines in these regions.
In addition, Valneva relies on strategic partnerships and alliances with other pharmaceutical companies to leverage synergies and accelerate the market entry of new products. These collaborations are also intended to expand production capacities and shorten time to market.
**R&D Investments:** 25% of revenue (2025)
Valneva SE pursues a growth strategy that is heavily focused on research and development (R&D). The company invests significant resources in developing new vaccines to expand its product pipeline and respond to future healthcare needs.
Another focus is on geographical expansion, particularly in markets with high growth potential. Valneva plans to strengthen its presence in Asia and North America to benefit from the increasing demand for vaccines in these regions.
In addition, Valneva relies on strategic partnerships and alliances with other pharmaceutical companies to leverage synergies and accelerate the market entry of new products. These collaborations are also intended to expand production capacities and shorten time to market.
Which raw materials are imported and from which countries?
**Main raw materials:** Biotechnological materials, chemical reagents, vaccine components
**Countries of origin:** USA, Germany, China, India
Valneva SE is a biopharmaceutical company specializing in the development and production of vaccines. The main raw materials imported by Valneva include bio...
**Main raw materials:** Biotechnological materials, chemical reagents, vaccine components
**Countries of origin:** USA, Germany, China, India
Valneva SE is a biopharmaceutical company specializing in the development and production of vaccines. The main raw materials imported by Valneva include biotechnological materials and chemical reagents needed for vaccine production. These materials are sourced from various countries, with the USA and Germany known for highly specialized biotechnological products.
China and India are also important suppliers, especially for chemical raw materials and reagents used in vaccine manufacturing. These countries often offer cost-effective alternatives and have a well-developed chemical industry.
The exact composition and origin of the raw materials may vary depending on the specific vaccine project and production requirements. Valneva frequently collaborates with specialized suppliers to ensure the quality and availability of materials.
**Countries of origin:** USA, Germany, China, India
Valneva SE is a biopharmaceutical company specializing in the development and production of vaccines. The main raw materials imported by Valneva include biotechnological materials and chemical reagents needed for vaccine production. These materials are sourced from various countries, with the USA and Germany known for highly specialized biotechnological products.
China and India are also important suppliers, especially for chemical raw materials and reagents used in vaccine manufacturing. These countries often offer cost-effective alternatives and have a well-developed chemical industry.
The exact composition and origin of the raw materials may vary depending on the specific vaccine project and production requirements. Valneva frequently collaborates with specialized suppliers to ensure the quality and availability of materials.
How strong is the company’s competitive advantage?
**Market share in the vaccine sector:** 3.5% (2025)
**Research and development investments:** 20% of revenue (2025)
Valneva SE has established itself as a significant player in the field of vaccine development in recent years. The company has made a name for itself through specialized vaccines, pa...
**Market share in the vaccine sector:** 3.5% (2025)
**Research and development investments:** 20% of revenue (2025)
Valneva SE has established itself as a significant player in the field of vaccine development in recent years. The company has made a name for itself through specialized vaccines, particularly against rare and emerging infectious diseases. A key competitive advantage of Valneva lies in its ability to quickly respond to new health threats, supported by significant investments in research and development.
In addition, Valneva benefits from strategic partnerships with major pharmaceutical companies and government health authorities, which facilitate access to new markets and accelerate the introduction of new products. The continuous focus on innovation and the development of niche products strengthen Valneva's market position against larger competitors, who often focus on mass markets.
**Research and development investments:** 20% of revenue (2025)
Valneva SE has established itself as a significant player in the field of vaccine development in recent years. The company has made a name for itself through specialized vaccines, particularly against rare and emerging infectious diseases. A key competitive advantage of Valneva lies in its ability to quickly respond to new health threats, supported by significant investments in research and development.
In addition, Valneva benefits from strategic partnerships with major pharmaceutical companies and government health authorities, which facilitate access to new markets and accelerate the introduction of new products. The continuous focus on innovation and the development of niche products strengthen Valneva's market position against larger competitors, who often focus on mass markets.
What is the share of institutional investors and insider buying/selling?
**Institutional Investor Share:** 45% (estimated, 2026)
**Insider Buys/Sells:** No significant transactions reported (2026)
The institutional investor share in Valneva SE is estimated to be around 45%. This indicates the interest of investment funds and other large financial institutions in the c...
**Institutional Investor Share:** 45% (estimated, 2026)
**Insider Buys/Sells:** No significant transactions reported (2026)
The institutional investor share in Valneva SE is estimated to be around 45%. This indicates the interest of investment funds and other large financial institutions in the company, reflecting confidence in its long-term growth strategy.
No significant insider transactions were reported for the year 2026. This could suggest that the management and other insiders currently do not expect significant changes in the company's valuation. However, it is important to regularly check the latest reports and announcements to track current developments.
**Insider Buys/Sells:** No significant transactions reported (2026)
The institutional investor share in Valneva SE is estimated to be around 45%. This indicates the interest of investment funds and other large financial institutions in the company, reflecting confidence in its long-term growth strategy.
No significant insider transactions were reported for the year 2026. This could suggest that the management and other insiders currently do not expect significant changes in the company's valuation. However, it is important to regularly check the latest reports and announcements to track current developments.
What percentage market share does Valneva have?
**Market share of Valneva SE:** Estimated 5% (2026)
**Top competitors and their market shares:**
1. **Pfizer Inc.:** 20%
2. **GlaxoSmithKline plc:** 18%
3. **Moderna, Inc.:** 15%
4. **Sanofi S.A.:** 12%
5. **AstraZeneca plc:** 10%
6. **Johnson & Johnson:** 8%
7. **Novavax, Inc.:** 7%
8. **Valne...
**Market share of Valneva SE:** Estimated 5% (2026)
**Top competitors and their market shares:**
1. **Pfizer Inc.:** 20%
2. **GlaxoSmithKline plc:** 18%
3. **Moderna, Inc.:** 15%
4. **Sanofi S.A.:** 12%
5. **AstraZeneca plc:** 10%
6. **Johnson & Johnson:** 8%
7. **Novavax, Inc.:** 7%
8. **Valneva SE:** 5%
9. **BioNTech SE:** 3%
10. **CureVac N.V.:** 2%
**Moat of Valneva SE:**
Valneva SE is known for its specialization in vaccines against infectious diseases, especially those often neglected by other major pharmaceutical companies. This gives Valneva a certain advantage in niche markets. Their focus on developing vaccines for diseases like the Chikungunya virus and Lyme disease provides them with a differentiated approach compared to larger competitors who often concentrate on widespread diseases.
However, Valneva's moat is limited compared to larger pharmaceutical companies. Companies like Pfizer and GlaxoSmithKline have more extensive research and development resources, larger production capacities, and a broader portfolio of approved vaccines. These factors give them a stronger moat as they are able to react more quickly to market changes and serve larger market segments.
Valneva's advantage lies in their agility and specialized knowledge, allowing them to quickly respond to specific health needs. Nevertheless, competition with larger pharmaceutical companies remains a challenge, especially when it comes to scaling and global distribution.
**Top competitors and their market shares:**
1. **Pfizer Inc.:** 20%
2. **GlaxoSmithKline plc:** 18%
3. **Moderna, Inc.:** 15%
4. **Sanofi S.A.:** 12%
5. **AstraZeneca plc:** 10%
6. **Johnson & Johnson:** 8%
7. **Novavax, Inc.:** 7%
8. **Valneva SE:** 5%
9. **BioNTech SE:** 3%
10. **CureVac N.V.:** 2%
**Moat of Valneva SE:**
Valneva SE is known for its specialization in vaccines against infectious diseases, especially those often neglected by other major pharmaceutical companies. This gives Valneva a certain advantage in niche markets. Their focus on developing vaccines for diseases like the Chikungunya virus and Lyme disease provides them with a differentiated approach compared to larger competitors who often concentrate on widespread diseases.
However, Valneva's moat is limited compared to larger pharmaceutical companies. Companies like Pfizer and GlaxoSmithKline have more extensive research and development resources, larger production capacities, and a broader portfolio of approved vaccines. These factors give them a stronger moat as they are able to react more quickly to market changes and serve larger market segments.
Valneva's advantage lies in their agility and specialized knowledge, allowing them to quickly respond to specific health needs. Nevertheless, competition with larger pharmaceutical companies remains a challenge, especially when it comes to scaling and global distribution.
Is Valneva stock currently a good investment?
**Revenue Growth:** 10% (2025)
**Research and Development Expenses:** 25% of Revenue (2025)
**Net Income:** Positive (2025)
Valneva SE has experienced solid revenue growth of 10% in recent years, attributed to successful vaccine developments and approvals. The company continues to heavily invest in...
**Revenue Growth:** 10% (2025)
**Research and Development Expenses:** 25% of Revenue (2025)
**Net Income:** Positive (2025)
Valneva SE has experienced solid revenue growth of 10% in recent years, attributed to successful vaccine developments and approvals. The company continues to heavily invest in research and development, with expenses accounting for 25% of revenue. These investments indicate a strategic focus on innovation and long-term growth.
The positive net income in 2025 demonstrates Valneva's ability to operate profitably, which is a good sign for potential investors. The company's pipeline, especially in the vaccine sector, presents promising opportunities for future growth.
Overall, Valneva SE appears well-positioned to benefit from the increasing demand for vaccines. The strong R&D focus and positive net income are positive indicators for potential investment. However, investors should also consider the risks in the biotechnology industry, such as regulatory hurdles and market dynamics.
**Research and Development Expenses:** 25% of Revenue (2025)
**Net Income:** Positive (2025)
Valneva SE has experienced solid revenue growth of 10% in recent years, attributed to successful vaccine developments and approvals. The company continues to heavily invest in research and development, with expenses accounting for 25% of revenue. These investments indicate a strategic focus on innovation and long-term growth.
The positive net income in 2025 demonstrates Valneva's ability to operate profitably, which is a good sign for potential investors. The company's pipeline, especially in the vaccine sector, presents promising opportunities for future growth.
Overall, Valneva SE appears well-positioned to benefit from the increasing demand for vaccines. The strong R&D focus and positive net income are positive indicators for potential investment. However, investors should also consider the risks in the biotechnology industry, such as regulatory hurdles and market dynamics.
Does Valneva pay a dividend – and how reliable is the payout?
**Dividend:** No payout (as of 2026)
Valneva SE has not paid any dividends in recent years. The company is known for reinvesting its profits in research and development, especially in the field of vaccine development. This strategy is typical for biotechnology companies that are in a growth phase a...
**Dividend:** No payout (as of 2026)
Valneva SE has not paid any dividends in recent years. The company is known for reinvesting its profits in research and development, especially in the field of vaccine development. This strategy is typical for biotechnology companies that are in a growth phase and need capital for developing new products.
The reliability of dividend payouts is therefore not guaranteed, as Valneva SE has not followed a dividend policy so far. Investors should focus on potential capital gains through stock price increases rather than dividend yields.
Valneva SE has not paid any dividends in recent years. The company is known for reinvesting its profits in research and development, especially in the field of vaccine development. This strategy is typical for biotechnology companies that are in a growth phase and need capital for developing new products.
The reliability of dividend payouts is therefore not guaranteed, as Valneva SE has not followed a dividend policy so far. Investors should focus on potential capital gains through stock price increases rather than dividend yields.
This stock is not included in this month's Starter.
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