Who owns valneva vaccine Infection with the chikungunya virus causes fever and severe joint pain that can persist Aug 18, 2022 · Overview . A full dose of the vaccine exhibited a more robust immune response compared to a half dose by providing protective antibody titers COVID-19 Vaccine (inactivated, adjuvanted) Valneva COVID-19 vaccine (inactivated, adjuvanted, adsorbed) Pharmacotherapeutic group(s) (ATC Code) Viral vaccines (JO7BX03) Marketing Authorisation Applicant Valneva Austria GmbH Campus Vienna Biocenter 3 1030 Vienna Austria Medicinal products to which this RMP refers 1 Invented name(s) in the Oct 25, 2023 · Valneva today announces the submission of a marketing application with the European Medicines Agency (EMA) for approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553. Sep 28, 2021 · Saint-Herblain (France) and New York (United States), September 28, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. Jul 11, 2019 · IXIARO®, or JESPECT® in Australia and New Zealand, is an inactivated Japanese encephalitis vaccine and is the only Japanese encephalitis vaccine currently approved for use in the United States, Canada and Europe. Its portfolio includes two vaccines for travellers; one for the prevention of Japanese encephalitis (IXIARO) and the Jun 13, 2023 · Saint-Herblain (France), June 13, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that the Company’s pivotal Phase 3 data for its single-shot chikungunya vaccine candidate, VLA1553, have been published in The Lancet , the world’s leading peer-reviewed medical journal. Nov 10, 2023 · French drugmaker Valneva said on Friday the U. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 500 employees. IXCHIQ® is approved in the United States, Canada and Europe. May 13, 2024 · Valneva’s vaccine IXCHIQ ® is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need. A Leading Specialty Vaccine Company Focused on vaccines that make a difference Proven Expertise: Three in-house vaccine approvals; three proprietary commercialized travel vaccines Focus on Innovation: Advancing first- , only- or best-in-class vaccine candidates; Experience across multiple vaccine platforms De-risked Blockbuster Lead Program: Valneva retains a right of first negotiation for potential product commercialization in Europe. Valneva Submits Chikungunya Vaccine Marketing Application to EMA and Announces CHMP Accelerated Assessment Oct 10, 2022 · At the World Vaccine Congress Europe in Barcelona, Valneva will present “One step closer to a chikungunya vaccine: update on Valneva’s live-attenuated vaccine candidate,” on October 13, 2022 at 2:45pm CEST. (NYSE: PFE) today announced a collaboration to develop and commercialize Valneva’s Lyme disease vaccine candidate VLA15, which is currently in 19 hours ago · Valneva Stock Performance. We are a specialty vaccine company focused on the development, manufacturing and commercialization of prophylactic vaccines for infectious diseases Nov 13, 2023 · Valneva Reports Positive Initial Phase 3 Safety Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate – Valneva Valneva Announces U. Sep 18, 2024 · To potentially include adolescents and antibody persistence up to two years. COVID-19 Vaccine (inactivated, adjuvanted) Valneva (COVID -19 vaccine (inactivated, adjuvanted, adsorbed)) EMA/265410/2023 Page 4/4 Based on the data provided, it was not possible, however, to draw any conclusion on the vac cine’s Lyme disease is the most common vector-borne illness in the Northern Hemisphere. Funded by the Coalition for Epidemic Preparedness […] S4V2 – The World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate. Milestone Follows FDA Fast Track and EMA PRIME Designations. Nov 9, 2023 · Nonetheless, the quality of the vaccine candidate and Valneva's willingness to support vaccine access in endemic countries convinced us to invest in their promising candidate. Valneva has announced positive outcomes from its Phase III VLA1553-321 trial of the single-shot IXCHIQ chikungunya virus (CHIKV) vaccine in adolescents. Jan 25, 2021 · Saint-Herblain (France), Sao Paulo, (Brazil), January 25, 2021 – Valneva SE (“Valneva” or “the Company”), a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need, and Instituto Butantan, producer of immunobiologic products, today announced the signing of definitive agreements for the development, manufacturing and marketing of Jun 24, 2022 · VLA2001 becomes the first COVID-19 vaccine to receive a standard marketing authorization in Europe. The vaccine contains whole particles of the original strain of SARS-CoV-2 that has been inactivated (killed) and cannot cause the disease. Dec 3, 2024 · Saint-Herblain (France), December 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive antibody persistence data three years after vaccination with a single dose of its chikungunya vaccine IXCHIQ ®. The trial demonstrated a ‘sustained’ sero A Chikungunya vaccine is a vaccine intended to provide acquired immunity against the chikungunya virus. It was approved by the U. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ® – Valneva. There are currently no preventive vaccines or effective Jun 23, 2022 · COVID-19 Vaccine (inactivated, adjuvanted) Valneva is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 to 50 years of age. Mar 21, 2024 · Saint-Herblain (France), March 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced it will present on its single-shot chikungunya vaccine, IXCHIQ ®, moderate a roundtable on the Zika and chikungunya viruses, and participate in a panel discussion on efforts to eradicate chikungunya at the 24th World Vaccine Congress, which will take place Mar 26, 2024 · Saint-Herblain (France), March 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the initiation of a Phase 1 clinical trial to investigate the safety and immunogenicity of VLA1601, its second-generation adjuvanted inactivated vaccine candidate against the Zika virus (ZIKV). Valneva’s cholera vaccine DUKORAL® is an oral vaccine indicated for the prevention of diarrhea caused by Vibrio cholera and/or heat labile toxin producing ETEC, the leading cause of travelers’ diarrhea. About Valneva’s Zika vaccine candidate (ZIKV) - VLA1601 VLA1601 is a highly Purified Inactivated Vaccine (“PIV”) candidate against the Zika virus, developed using the same manufacturing platform as Valneva’s IXIARO® (JESPECT®) North American Vaccine, Inc. (*) including 4,049,170 ordinary shares under the form of 2,024,585 American Depositary Shares (ADS), each ADS representing two ordinary shares of the Company (information as of December 31, 2024). Jan 6, 2022 · Speciality vaccines company Valneva said it was keeping its previous timetable on clinical trials and regulatory submissions for its VLA2001 COVID-19 vaccine candidate, with regulatory approvals Sep 7, 2023 · About Valneva SE. 1 Jul 11, 2019 · Valneva is a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ® - Valneva 5 days ago · Valneva SE is a vaccine company focused on developing life-saving vaccines. The results are in line with Valneva’s expectations for this vaccine, confirming a Oct 18, 2021 · VLA2001 successfully met both co-primary endpoints Superior neutralizing antibody titer levels compared to active comparator vaccine, AstraZeneca’s AZD1222 (ChAdOx1-S) Neutralizing antibody seroconversion rate above 95% VLA2001 induced broad T-cell responses with antigen-specific IFN-gamma-producing T-cells against the S, M and N proteins. 4 Valneva Announces U. Jun 23, 2022 · Saint-Herblain (France) and New York, June 23, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. 85 on Monday. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop Jan 25, 2021 · Saint-Herblain (France), Sao Paulo, (Brazil), January 25, 2021 – Valneva SE (“Valneva” or “the Company”), a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need, and Instituto Butantan, producer of immunobiologic products, today announced the signing of definitive agreements for the development, manufacturing and marketing of Jan 19, 2022 · Preliminary laboratory studies demonstrate that three doses of Valneva’s inactivated COVID-19 vaccine candidate VLA2001 induced neutralization of the Omicron variant (B. Saint Herblain (France), June 24, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Commission (EC) has granted marketing authorization in Europe for Valneva’s inactivated whole-virus COVID-19 vaccine, VLA2001, for use as Apr 30, 2020 · Phase 2 vaccine candidate, VLA15, is being evaluated for adult and pediatric indications in North America and Europe. The company’s fifty day Valneva Sweden was honored to attend the opening ceremony for International Vaccine Institute (IVI)’s new European office in Stockholm on May 3, 2024. This background document on the Valneva VLA2001 vaccine against COVID-19 was prepared by the Working Group on COVID-19 Vaccines of the Strategic Advisory Group of Experts (SAGE) on Immunization to inform SAGE deliberations. Medicinal product no longer authorised Apr 25, 2022 · Saint Herblain (France), April 25, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today provided an update on the rolling review process of its inactivated, COVID-19 vaccine candidate, VLA2001, with the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”). While the Danish biotechnology company has worked on vaccines since its founding in the early ‘90s, it has largely relied on government contracts, including for its VALNEVA SE Campus Bio-Ouest | 6, Rue Alain Bombard 44800 Saint-Herblain, France Valneva Initiates Phase 1 Trial of Second-Generation Zika Vaccine Candidate Saint-Herblain (France), March 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a 1 Valneva Reports Positive Pivotal Phase 3 Immunogenicity Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate - Valneva 2 Valneva Announces U. (NYSE: PFE), with the planned initiation of study Valneva‘s In-House Expertise and Capabilities for JE Vaccine (PIV) can be applied to Development of Zika Virus Vaccine 04-APRIL-2018 14 JE vaccine (PIV) + Successful collaboration and tech transfer (WRAIR) + Master & working cell bank characterization + Process development: modern production process / excellent FDA track-record. The firm has a market cap of $394. (NYSE: PFE), today announced further positive Phase 2 results, including booster response, for Lyme disease vaccine candidate VLA15. FDA Approval of World's First Chikungunya Vaccine 9 Meticulous Development Leveraging our Strengths in Development and Manufacturing Initial U. 5 million Net Profit of €24. The article, titled “Safety and immunogenicity of a single-shot […] vaccines being developed using Valneva´s innovative and validated technology platforms (EB66® ®vaccine production cell line, IC31 adjuvant). Valneva COVID-19 vaccine is a COVID-19 vaccine developed by French biotechnology company Valneva SE in collaboration with the American biopharmaceutical company Dynavax Technologies. Jul 7, 2021 · This new U. Funded by the Coalition for Epidemic Preparedness Innovations (CEPI Valneva is the first company to advance a chikungunya vaccine candidate into Phase 3. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ® - Valneva 3 Valneva Announces U. A full dose of the vaccine exhibited a more robust immune response compared to a half dose by providing protective antibody titers Aug 28, 2023 · Saint-Herblain (France), August 28, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive initial Phase 3 safety data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553. Saint Herblain (France), September 18, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted label extension applications to the European Medicines Agency (EMA) and Health Canada to potentially expand the use of its chikungunya vaccine, IXCHIQ Mar 8, 2021 · VLA15 is the only Lyme disease vaccine candidate in active clinical development Saint-Herblain (France) and New York, NY, March 8, 2021 – Valneva SE (“Valneva”), a specialty vaccine company focused on prevention of diseases with major unmet needs, and Pfizer Inc. When administered concomitantly, the vaccines should be injected in separate Oct 21, 2024 · Saint-Herblain (France), October 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today that members of its senior leadership team will present datasets on the world’s first and only approved chikungunya vaccine, IXCHIQ®, at several leading scientific conferences during the fourth quarter of 2024. Valneva´s vaccine candidate VLA15, under Fast Track Designation by the FDA, is a multivalent vaccine that targets the outer surface protein A (OspA) of Borrelia. The sponsor of the first chikungunya vaccine Biologics License Application (BLA) to be approved in the U. announced today positive immunogenicity and safety data from their VLA15-221 Phase 2 study following a second booster vaccination of their Lyme disease vaccine candidate, VLA15, given one year after receiving the first booster dose. FDA in November 2023 [4] , and the Centers for Disease Control and Prevention (CDC) recently adopted the Advisory Committee on Immunization Practices’ (ACIP Mar 8, 2022 · Valneva is a specialty vaccine company focused on the development, production and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Credit: Valneva SE. Approval Nov 9, 2023 Rolling BLA4 submission 2022 Phase 3 2020 –2021 NHP Study Phase 1 2018 –2019 In-licensing/ pre Valneva’s vaccine was highly immunogenic in both dose groups. The paper, entitled “Immunogenicity and 6 days ago · Valneva's vaccine was highly immunogenic in both dose groups. It was 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 COVID-19 May 5, 2020 · Saint-Herblain (France), Sao Paulo, (Brazil), May 5, 2020 – Valneva SE (“Valneva” or “the Company”), a specialty vaccine company, and Instituto Butantan, producer of immunobiologic products, today announced the signing of a binding term sheet for the development, manufacturing and marketing of Valneva’s single-shot chikungunya vaccine, VLA1553, in Low and Middle Income Countries Oct 4, 2022 · Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. COVID-19 Vaccine (inactivated, adjuvanted) Valneva works by preparing the body to defend itself against COVID-19. 12 million, a price-to-earnings ratio of -37. Food and Drug Administration (FDA) to potentially extend the use of its chikungunya vaccine IXCHIQ ®, which is Mar 2, 2023 · Saint-Herblain (France), March 2, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced additional data from remaining clinical studies and an update on regulatory submissions for its inactivated COVID-19 vaccine, VLA2001. The trial builds on recommendations for use of the Valneva vaccine VLA2001 against COVID-19 18 August 2022. 5 to 5 million deaths each year and have transformed global public health. [7][8][9] Jun 20, 2022 · Pfizer has agreed to pay €90. Inactive: 4/13/2016: NVX : Novavax, Inc. By Reuters. Saint Herblain (France), November 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted a label extension application to the U. Vaccines marketed by Valneva include Ixiaro, a vaccine against Japanese encephalitis (approved in Europe, America and Australia) [6] and Dukoral, a vaccine against cholera (approved in Europe and Australia). Valneva in-licensed S4V2 as part of an exclusive worldwide development, manufacturing, and commercialization agreement with LimmaTech Biologics AG [2]. Following receipt of the European Commission (EC)’s notice of intent to terminate the Advance Purchase Agreement (APA)[1], Valneva proposed a remediation plan, which is now subject to further discussion within 2 days ago · New data for Valneva and Pfizer's Lyme disease vaccine bolsters the case for the shot as the results of a phase 3 Valneva and Pfizer are now predicting a filing for approval of VLA15 in the US Dec 19, 2024 · Saint-Herblain (France), Pune, (India), December 19, 2024 – Valneva SE (“Valneva” or “the Company”), a specialty vaccine company, and Serum Institute of India (SII), the world’s largest manufacturer of vaccines by number of doses, today announced an exclusive license agreement for Valneva’s single-shot chikungunya vaccine that enables supply of the vaccine in Asia. When administered concomitantly, the vaccines should be injected in separate May 30, 2023 · Saint-Herblain (France), May 30, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the filing of a regulatory application with Health Canada for marketing approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553, in persons aged 18 years and above. 5mn for an 8. Dec 31, 2022 · Total revenues of €361. 11, Europe 12, and Canada 13 Nov 3, 2021 · Saint-Herblain (France), November 3, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (the “Company”), a specialty vaccine company, announced today the closing which occurred on November 2, 2021 of its previously announced global offering to specified categories of investors of an aggregate 5,175,000 new ordinary shares, after full exercise of the overallotment option granted […] Nov 13, 2024 · Saint Herblain (France) and Schlieren (Zurich), November 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the first participant has been vaccinated in a Phase 2b controlled human infection model (CHIM) […] May 31, 2024 · Saint Herblain (France), May 31, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of Valneva’s single-dose vaccine for the Aug 5, 2022 · vaccines and inferred from co-administration studies of other adult vaccines, COVID-19 vaccines may be given concomitantly with, or at any time before or after, other adult vaccines, including live attenuated, inactivated, adjuvanted, or non-adjuvanted vaccines. The use of this vaccine should be in accordance with official recommendations. / EU approved vaccine against Japanese encephalitis Most clinically advanced Lyme vaccine program worldwide Potential for first/best-in-class 4 Established Cholera (ETEC*) vaccine approved in >30 countries World‘s first and only approved chikungunya vaccine (U. Today, Takeda’s global vaccine business is applying innovation to tackle some of the world’s most challenging infectious diseases, such as dengue Jun 23, 2022 · Saint Herblain (France), June 23, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization in Europe for Valneva’s inactivated whole-virus COVID-19 vaccine candidate, VLA2001, for use as primary vaccination Oct 18, 2021 · The Valneva Covid vaccine that the UK cancelled a 100m dose order for last month, works well at priming the immune system to fight coronavirus, phase three trial results suggest. Aug 18, 2022 · This webpage was published on 18 August 2022. Dec 6, 2022 · Live event and webcast TODAY at 10 AM – 12 PM ET Saint-Herblain (France), December 06, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, is hosting an in-person investor day today in New York City to discuss the Company’s current vaccine pipeline, commercial products, and future directions. 31 and a beta of 1. 1 per cent stake in Valneva, in a move that will bolster the French vaccine company’s Lyme disease programme. S. The trials compared the immune response rates Jun 23, 2022 · How COVID-19 Vaccine (inactivated, adjuvanted) Valneva works. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ® - Valneva 5 ACIP Vaccine Recommendations and Schedules | CDC 6 Safety and immunogenicity of a single-shot live-attenuated chikungunya vaccine: a double-blind, multicentre, randomised, placebo-controlled, phase 3 trial - The Lancet Valneva press release: Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA15, Valneva and Pfizer Enter into an Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15; Valneva press release: Valneva Receives FDA Fast Track Designation for Nov 9, 2021 · Phase-three trials for the Valneva vaccine were carried out on more than 4,000 patients aged 18 years and older across 26 sites in the United Kingdom. Valneva's candidate is the only vaccine in clinical development worldwide. Valneva was also granted accelerated assessment[1] for the application by EMA’s Committee for Medicinal Products for Human Use (CHMP) based on the vaccine candidate’s “major interest for public Dec 3, 2024 · Valneva Successfully Expands Access to Asia for its Chikungunya Vaccine with Serum Institute of India December 4, 2024 Valneva Announces Peer-Reviewed Publication on the Global Health and Economic Burden of Chikungunya in The British Medical Journal Oct 6, 2019 · Valneva’s Lyme vaccine isn’t the first designed for people. Valneva is set to showcase its pioneering chikungunya vaccine, IXCHIQ®, at several esteemed scientific forums this quarter, highlighting two-year antibody VLA1553: Clinical Data Highlights1,2,5 Live-attenuated CHIKV vaccine demonstrates rapid and long-lasting immunity with a single shot VLA1553 was generally well tolerated among the >3,600 Apr 30, 2020 · Phase 2 vaccine candidate, VLA15, is being evaluated for adult and pediatric indications in North America and Europe. It is currently approved in the U. Following last week’s meeting, the […] Jun 20, 2022 · Pfizer will invest €90. Food and Drug Administration (FDA) has granted Fast Track designation to Shigella4V (S4V Aug 8, 2022 · Approximately 6,000 participants 5 years of age and older will be enrolled in Lyme disease-endemic regions in Europe and the U. We take a highly Jan 31, 2022 · CEPI-funded trial intended to support potential label expansion in this age group Saint-Herblain (France), January 31, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the initiation of a Phase 3 trial in adolescents for its single-shot chikungunya vaccine candidate, VLA1553. Valneva’s Chief Executive […] Sep 30, 2023 · In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results or delays, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, the Valneva is a specialty vaccine company focused on the development, manufacturing and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. This new designation from the EMA Sep 6, 2022 · Saint-Herblain (France), September 6, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that The Lancet Infectious Diseases (“The Lancet ID”), a peer-reviewed medical journal, has published the Company’s pivotal Phase 3 clinical data for its inactivated, whole-virus COVID-19 vaccine, VLA2001. will be eligible to receive a Priority Review Voucher (PRV) 5. in November 2023 1,2 and in Canada and Europe in June 2024 3,4. ); Review ongoing in Europe, Canada & Brazil There are no data available on the interchangeability of COVID-19 Vaccine (inactivated, adjuvanted) Valneva with other COVID-19 vaccines to complete the vaccination course. 6 million of COVID-19 vaccine sales €246. Dec 11, 2023 · The vaccine, Ixchiq, was developed by French specialty vaccine company Valneva, located in Saint-Herblain. 5 million in Valneva ; Planned Phase 3 study confirmed to initiate in Q3 2022; Saint-Herblain (France) and New York, June 20, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. 529 lineage) 100% of tested serum samples presented neutralizing antibodies against the ancestral virus and Delta variant, and 87% against the Omicron variant Saint Herblain (France), January 19, 2022 – Valneva SE Jul 25, 2019 · Oslo, Norway, and Saint-Herblain, France, July 25, 2019—Valneva SE (“Valneva”), a biotech company developing and commercializing vaccines for infectious diseases with major unmet needs, and the Coalition for Epidemic Preparedness Innovations (CEPI) hereby announce a new partnering agreement. Funded by the Coalition for Epidemic Preparedness Innovations […] Aug 5, 2022 · vaccines and inferred from co-administration studies of other adult vaccines, COVID-19 vaccines may be given concomitantly with, or at any time before or after, other adult vaccines, including live attenuated, inactivated, adjuvanted, or non-adjuvanted vaccines. The vaccine, which will be sold as Ixchiq, is approved for U. 3 million Includes €61. Shares of VALN opened at $4. VLA2001 was well tolerated, demonstrating a Aug 23, 2022 · Saint-Herblain (France), August 23, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, confirms today that the World Health Organization (WHO) has issued recommendations for use of the Company’s inactivated COVID-19 vaccine. Shigella4V2 (S4V2) is a tetravalent bioconjugate vaccine candidate against shigellosis. [8] The first chikungunya vaccine was approved for medical use in the United States in Jul 1, 2024 · Saint Herblain (France), July 1, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Commission (EC) has granted marketing authorization in Europe for Valneva’s single-dose vaccine, IXCHIQ ®, for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced the initiation of a Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), to Valneva’s single-shot chikungunya vaccine – VLA1553 / IXCHIQ® . Valneva Investor and Media Feb 4, 2022 · Saint-Herblain (France) and New York, February 4, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. 15. (NYSE: PFE) today reported further positive Phase 2 data for their Lyme disease vaccine candidate, VLA15. These WHO interim recommendations for use of the Valneva VLA2001 vaccine were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) on its 11 August 2022 extraordinary meeting and the evidence summary included in the background document and annexes referenced below. Saint Herblain (France), July 7, 2021 – Valneva SE (“Valneva” or “the Company”), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced that it has been awarded Breakthrough Therapy A Leading Specialty Vaccine Company Focused on vaccines that make a difference Proven Expertise: Three in-house vaccine approvals; three proprietary commercialized travel vaccines Focus on Innovation: Advancing first- , only- or best-in-class vaccine candidates; Experience across multiple vaccine platforms Aug 18, 2023 · Amongst vaccines in the pipeline, a live attenuated CHIKV vaccine developed by Valneva (with CEPI support) has completed Phase 3 studies and is nearing licensure in the US and EU followed by other Oct 21, 2024 · Valneva (VALN) has released an update. He has a long-standing and proven track record in corporate and business development as well as strategic management with more than 20 years in the biotech industry. At the International Society of […] Aug 18, 2022 · Overview . 7 million, including proceeds from the Priority Review Voucher (PRV)[1] sale Operating profit of €34. 1. For more information, visit www. adults 18 years and older who are at increased risk of exposure to the chikungunya virus. Context The COVID-19 Valneva (VLA2001) vaccine is a highly purified, inactivated, and adjuvanted whole virus SARS-CoV-2 vaccine. It is based on the Valneva core non-clinical and clinical data for regulatory evaluation. ); Review ongoing in Europe, Canada & Brazil Nov 27, 2023 · Saint-Herblain (France), November 27, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) has performed a technical validation of the Marketing Authorization Application (MAA) for Valneva’s single-shot chikungunya vaccine candidate VLA1553 and has determined that all essential regulatory elements IXCHIQ®: The 3rd Vaccine Valneva has brought from early R&D to approval1 U. IXCHIQ® was granted approval in the U. The WHO Strategic Advisory Group of Experts on Immunization (SAGE) has issued interim policy recommendations for the use of the Valneva (VLA2001) vaccine. Food and Drug Administration (FDA) has approved its Chikungunya single-dose vaccine in individuals aged 18 and above. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic Aug 18, 2022 · WHO recommends Valneva's COVID vaccine. (NYSE: PFE) today announced a collaboration to develop and commercialize Valneva’s Lyme disease vaccine candidate […] The chikungunya vaccine IXCHIQ® is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need. View More Jul 22, 2024 · Valneva to receive up to $41. This ceremony was special, as it marked a significant milestone for our partners in their commitment to fostering global health through innovative vaccine research and development. The Valneva vaccine is a purified, inactivated, and adjuvanted whole virus SARS-CoV-2 vaccine. Oct 16, 2024 · Saint Herblain (France) and Schlieren (Zurich), October 16, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the U. As previously announced, Valneva will not invest in further development of the vaccine, in the absence of a […] Aug 18, 2022 · This document refers to the COVID-19 Valneva vaccine (VLA2001) developed by Valneva. Jun 10, 2022 · Saint-Herblain (France), June 10, 2022 – Valneva SE, a specialty vaccine company, today provides an update on its European inactivated whole-virus COVID-19 vaccine candidate VLA2001. [5] The most commonly reported side effects include headache, fatigue, muscle pain, joint pain, fever, nausea and tenderness at the injection site. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that they have completed recruitment for the Phase 3 trial Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) for Lyme disease vaccine candidate VLA15. Dec 2, 2020 · Saint-Herblain (France), December 2, 2020 – Valneva SE (“Valneva”), a specialty vaccine company focused on prevention of diseases with major unmet needs, today announced its plans to accelerate pediatric development of its Lyme vaccine candidate, VLA15, in collaboration with Pfizer Inc. 3 million in 2022 compared to €348. 6 million, including product sales of €112. Valneva is headquartered in Lyon, France, listed on Euronext-Paris and the Vienna stock exchange and operates out of France, Austria and Scotland with approximately 270 employees. Based on these new results, Valneva and Pfizer plan to proceed with a three-dose primary Saint-Herblain (France), October 16, 2020 – Valneva SE (“Valneva” or “the Company”) a specialty vaccine company focused on prevention of diseases with major unmet needs, today announced that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation for its single-shot Phase 3 chikungunya vaccine candidate VLA1553. com and follow the Company on LinkedIn. Active: 10/8/2020: NYB Only U. 2 million in the first nine-months of 2023 Cash position of €156. While Novartis vaccines may still be in circulation, its status is set to not active. The Phase 3 trial “Cov-Compare Feb 17, 2023 · Valneva is a specialty vaccine company focused on the development, manufacturing and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. These results support and strengthen the pivotal data Nov 26, 2024 · To potentially include adolescents and antibody persistence up to two years. The Company will also have a display in the exhibit area at booth #46 for the duration of the Congress, from October 11 through 14, 2022. As announced on February 25, 2022, […] Jul 1, 2024 · Saint Herblain, July 1, 2024– Valneva SE, a specialty vaccine company, today announced that the European Commission has granted marketing authorization in Europe for Valneva’ s single-dose Sep 14, 2020 · The Company has various vaccines in development including unique vaccines against Lyme disease, chikungunya and COVID-19. Saint Herblain (France) and New York, NY, April 30, 2020 – Valneva SE (“Valneva”), a specialty vaccine company, and Pfizer Inc. 3 million from CEPI and the European Union to expand access to chikungunya vaccine, IXCHIQ® Funding will support clinical trials in vulnerable groups, such as children and pregnant women Partnership will also support technology transfer to an additional manufacturer to supply IXCHIQ® to Asian LMICs IXCHIQ® is already approved for […] Jan 21, 2025 · Valneva’s IXCHIQ claims to be the only licenced vaccine for CHIKV globally. The Phase 2 study, VLA15-202, is evaluating the immunogenicity and safety of […] Mar 11, 2022 · Saint Herblain (France), March 11, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today provided an update on the regulatory review of its inactivated, COVID-19 vaccine candidate, VLA2001, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). 2 million of travel vaccine sales and €29. The VLA15-221 Aug 5, 2022 · vaccines and inferred from co-administration studies of other adult vaccines, COVID-19 vaccines may be given concomitantly with, or at any time before or after, other adult vaccines, including live attenuated, inactivated, adjuvanted, or non-adjuvanted vaccines. First results of the trial are expected mid-2023. The global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032. 2 million compared to an operating loss of €57. August 18, 2022 5:52 PM UTC Updated ago. 1 million in 2021 Driven by product sales of €114. Without the support from CEPI and the European Union's Horizon 2020 Programme this vaccine might have remained a product principally targeting travellers from the Global Sep 3, 2024 · Valneva SE and Pfizer Inc. Twenty years ago, Reeder could have been immunized. 93. 3% sero-response rate one-year after single vaccination. This brings the total […] VLA1601 – Valneva’s Second-Generation Zika Vaccine Candidate VLA1601 is a highly purified inactivated vaccine candidate against the Zika virus. 3% increase compared to 2021), including €85. 5 million of Other Revenues, primarily driven by revenue recognition related to previous COVID-19 vaccine supply […] Feb 29, 2024 · Saint-Herblain (France), February 29, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today that the U. VLA1553 would expand Valneva’s existing travel vaccine portfolio and as such, Valneva Dec 8, 2022 · Vaccines prevent 3. If accepted, Health Canada will provide additional information on […] 5 days ago · Valneva estimates that the global market for a Shigella vaccine could be $500 million a year, targeted at people in LMICs, as well as travellers and military personnel staying in areas where Nov 7, 2024 · Nine-Month Key Financial Highlights Total revenues of €116. valneva. WHO’s interim recommendations for use of the Valneva VLA2001 vaccine were developed on the basis of advice issued by […] 6 days ago · IXCHIQ ® is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need. (NYSE: PFE) today announced that they have entered into an Equity Subscription Agreement and have updated the terms of their Collaboration and Sep 18, 2024 · Saint Herblain, September 18, 2024– Valneva SE, a specialty vaccine company, today announced that it has submitted label extension applications to the European Medicines Agency and Health Canada Only U. Feb 14, 2023 · Saint-Herblain (France), February 14, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it completed enrollment and vaccination for a Phase 3 trial in adolescents, VLA1553-321, of its single-shot chikungunya vaccine candidate, VLA1553. Today, Takeda, the largest drug company in Asia, owns that vaccine and is Sep 27, 2023 · Riding high from sales of an mpox vaccine, Bavarian Nordic began 2023 with one major goal in mind: becoming one of the largest pure-play vaccine manufacturers in the world. New York & Saint-Herblain (France), August 8, 2022 – Pfizer Inc. With support from the European Union’s (EU’s) Horizon 2020 programme, CEPI will provide Nov 10, 2023 · The Food and Drug Administration on Thursday cleared drugmaker Valneva's preventive chikungunya virus vaccine in adults, the first shot to prevent illness from the mosquito-borne disease. Jan 10, 2024 · Saint-Herblain, January 10, 2024– Valneva SE today announced that the first participant has been vaccinated in the Phase 2 clinical trial evaluating the safety and Immunogenicity in children of Apr 21, 2021 · Saint-Herblain (France), April 21, 2021 – Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced it has initiated a pivotal Phase 3 clinical trial for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Jan 20, 2025 · Saint-Herblain (France), January 20, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported further positive Phase 3 data in adolescents for its single-shot chikungunya virus (CHIKV) vaccine, IXCHIQ®, which showed a sustained 98. 2 million in Aug 5, 2021 · VLA1553 would expand Valneva’s existing travel vaccine portfolio and as such, Valneva intends to commercialize this vaccine, if approved, leveraging its existing manufacturing and commercial operations. Individuals who have received the first dose of COVID-19 Vaccine (inactivated, adjuvanted) Valneva should receive the . When administered concomitantly, the vaccines should be injected in separate Dec 4, 2023 · New York, NY, and Saint-Herblain (France), December 4, 2023 – Pfizer Inc. Nov 13, 2024 · Morningstar brands and products Company Portfolio + Global JE vaccines market valued at ~€150-200m6 › Traveler 65%, Military 15%, Endemic 20%5 › ~68,000 symptomatic cases in Asia each year7 + Significant growth potential in key markets Commercial position + Currently, no effective treatment for the disease3 + Valneva’s vaccine is the only approved vaccine available for US and EU travelers Feb 1, 2021 · Saint-Herblain (France), February 1st, 2021 – Valneva SE (“Valneva” or “the Company”), a specialty vaccine company focused on prevention against diseases with major unmet needs, today reported that the UK Government has exercised its option to order 40 million doses of its inactivated, adjuvanted COVID-19 vaccine candidate for supply in 2022. Background document on the Valneva vaccine (VLA2001) against COVID-19 -2- Sep 3, 2024 · About Valneva SE We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. (NYSE: PFE) today announced the closing of the equity investment announced on June 20, 2022. xv For more than 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend use of Valneva’s single-dose chikungunya vaccine IXCHIQ ® for the Jun 24, 2024 · Saint-Herblain (France), June 24, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that Health Canada has approved IXCHIQ ®, Valneva’s single-dose vaccine for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop Jul 11, 2019 · We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs Jan 10, 2024 · Saint-Herblain (France), January 10, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that the first participant has been vaccinated in the Phase 2 clinical trial evaluating the safety and Immunogenicity in children of two different dose levels of Valneva’s single-shot chikungunya vaccine. This document refers to the COVID-19 Valneva vaccine (VLA2001) developed by Valneva. (NYSE: PFE) today announced initiation of study VLA15-221. Dec 31, 2024 · Valneva’s share capital is comprised of 162,521,524 ordinary shares (*) (ISIN FR0004056851), with a par value of €0. Valneva logo and stock graph are seen displayed in this illustration taken, May 3, 2022. Immunogenicity data for the trial are expected in November 2023. part of Baxter: Inactive: 5/28/2010: NOV : Novartis Pharmaceutical Corporation: Novartis has sold its flu vaccines to Seqirus and other vaccines to GlaxoSmithKline. 8 million (82. Our strategy is based on an integrated business model that has allowed us to build a portfolio of differentiated clinical and pre-clinical assets as well as a robust commercial Franck Grimaud was co-founder, President and CEO of Vivalis and co-led its merger with Intercell to create Valneva. inzki pvofm otrufy datsnq fekv rwwequ ejqv hdjln itfcb nldmxpq