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 the safety and immunogenicity of VLA1601, its second-generation adjuvanted inactivated vaccine candidate against the Zika virus (ZIKV). There are currently no preventive vaccines or effective treatments available against ZIKV. As such, this mosquito-borne disease remains a public health threat and is...
Saint-Herblain (France), March 25, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today the filing, on March 22, 2024, of its 2023 Universal Registration Document (URD) with the French Financial Markets Authority (AMF) under the filing number D.24-0157 and its Form 20-F with the U.S. Securities and Exchange Commission (SEC). Valneva’s 2023 Universal Registration Document – available in its entirety in French – includes the Company’s 2023...
Saint-Herblain (France), le 21 mars 2024 – Valneva SE (Nasdaq : VALN; Euronext Paris : VLA), société spécialisée dans les vaccins, a annoncé aujourd’hui qu’elle fera une présentation sur son vaccin à injection unique contre le chikungunya, IXCHIQ ® , animera une table ronde sur les virus Zika et chikungunya, et participera à un débat sur les efforts d'éradication du chikungunya lors du 24ème World Vaccine Congress, qui se tiendra du 1er au 4 avril 2024 au Walter E. Washington...
Total revenues of €153.7 million, including product sales of €144.6 million Product sales surpassed pre-pandemic (2019) sales by 12% and 2022 sales by 26% Excluding COVID-19 vaccine sales, product sales grew by 63% compared to 2022 Cash position of €126.1 million at year-end 2023 enhanced by €95 million from sale of Priority Review Voucher (PRV) 1 Extended the interest-only period of existing debt financing agreement to January 2026 significantly extending cash runway 2 Operational...
Reimbursements deferred by 18 months to start in January 2026 instead of July 2024 Saint-Herblain (France), March 18, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced an agreement with funds managed by leading U.S. healthcare investment firms Deerfield Management Company and OrbiMed to extend the interest-only period of its existing loan by eighteen months. Reimbursements of the first $100 million tranche will now start in January 2026 instead...
VALNEVA Déclaration d’actions et de droits de vote 29 février 2024 __________________________________________________________________________________________ Dénomination sociale : VALNEVA Adresse du siège social : 6 rue Alain Bombard, 44800 Saint-Herblain Marché réglementé Euronext Paris - Compartiment B Date de la déclaration : 6 mars 2024 Nombre d’actions composant le capital de Valneva Nombre total de droits de vote incluant les droits de vote suspendus* Origine de la variation...
Saint-Herblain (France), March 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will participate at upcoming investor conferences in the United States and Europe. CEO Thomas Lingelbach will present Valneva at the TD Cowen 44th Annual Health Care Conference, taking place March 4 - 6, 2024, in Boston, MA. Mr. Lingelbach and CFO Peter Bühler will also meet with institutional investors during the Van Lanschot Kempen...
Le Comité consultatif sur la vaccination aux États-Unis (ACIP) recommande l’utilisation d’IXCHIQ ® , le vaccin à injection unique contre le chikungunya de Valneva La recommandation pour l’utilisation chez les voyageurs et le personnel de laboratoire fait suite à l’approbation du vaccin par l’agence de santé américaine Food and Drug Administration (FDA) en novembre 2023 1 IXCHIQ ® est le premier et le seul vaccin autorisé au monde contre le chikungunya pour répondre à ce...
Valneva publie son chiffre d’affaires et sa trésorerie pour l’exercice 2023 et fournit des indications préliminaires pour l’exercice 2024 Chiffre d’affaires total de 153,7 millions d’euros dont 144,6 millions d’euros de ventes de produits Les ventes excèdent de 12% celles de 2019 (précédant la pandémie) et de 26% celles de 2022 Hormis les ventes du vaccin COVID-19, les ventes de produits progressent de 63% par rapport à 2022 Trésorerie de 126,1 millions d’euros au 31...
VALNEVA Declaration of shares and voting rights January 31, 2024 __________________________________________________________________________________________ Company name: VALNEVA Registered office: 6 rue Alain Bombard, 44800 Saint-Herblain (France) Regulated market of Euronext Paris - Compartment B Declaration date: February 7, 2024 Number of shares composing the share capital of Valneva Total number of voting rights including suspended voting rights* Description of the change Date on which this...
Saint-Herblain (France), February 5, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced it sold the Priority Review Voucher (PRV) it received from the U.S. Food and Drug Administration (FDA) for $103 million (€95 million). The Company was awarded a tropical disease PRV in November 2023 1 following U.S. FDA approval of IXCHIQ ® , Valneva’s single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya...
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. The Company reported positive pivotal Phase 3 data in adolescents two months ago confirming the immunogenicity and safety profile observed in adults 1 . There is currently no approved...
VALNEVA Déclaration d’actions et de droits de vote 31 décembre 2023 __________________________________________________________________________________________ Dénomination sociale : VALNEVA Adresse du siège social : 6 rue Alain Bombard, 44800 Saint-Herblain Marché réglementé Euronext Paris - Compartiment B Date de la déclaration : 5 janvier 2024 Nombre d’actions composant le capital de Valneva Nombre total de droits de vote incluant les droits de vote suspendus* Origine de la...
Saint-Herblain (France), 4 janvier 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), société spécialisée dans les vaccins, annonce aujourd’hui que des membres de son équipe dirigeante, dont Thomas Lingelbach, CEO, et Peter Bühler, CFO, rencontreront des investisseurs du 8 au 10 janvier 2024 lors de la 42 ème « J.P. Morgan Healthcare Conference » à San Francisco et participeront virtuellement au Oddo BHF Forum le 15 janvier 2024. Les CEO et CFO de Valneva évoqueront notamment...
Saint-Herblain (France), December 29, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Company is modifying its financial guidance for 2023. Product sales guidance remains unchanged, as do anticipated R&D expenses. The €90 million to €110 million of other income related to proceeds from potential sale of the Company’s priority review voucher (PRV), which was previously expected before year-end, is now expected in early 2024. The...
Anne-Marie Graffin is appointed as Chair of the Board of Directors Saint-Herblain (France), December 20, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its shareholders approved the resolutions recommended by the Management Board at its Extraordinary General Meeting (EGM) held on December 20, 2023. These included the immediate transition from the Company’s two-tier governance model to a one-tier model led by a Board of Directors....
VALNEVA Déclaration d’actions et de droits de vote 30 novembre 2023 __________________________________________________________________________________________ Dénomination sociale : VALNEVA Adresse du siège social : 6 rue Alain Bombard, 44800 Saint-Herblain Marché réglementé Euronext Paris - Compartiment B Date de la déclaration : 6 décembre 2023 Nombre d’actions composant le capital de Valneva Nombre total de droits de vote incluant les droits de vote suspendus* Origine de la...
Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15 9,437* participants enrolled at sites across the U.S., Europe and Canada in areas where Lyme disease is endemic Trial conclusion expected by year-end 2025 Pfizer aims to submit regulatory filings in the U.S. and Europe in 2026 New York, NY, and Saint-Herblain (France), December 4, 2023 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that they...
Valneva annonce des données positives sur la persistance des anticorps à 24 mois pour son vaccin à injection unique contre le chikungunya, IXCHIQ ® Critère d'évaluation principal atteint avec un taux de séro-réponse de 97 % vingt-quatre mois après vaccination avec une seule dose Les taux d'anticorps sont restés élevés et nettement au-dessus du seuil de séro-réponse défini, et sont ainsi en faveur d’une réponse immunitaire de long terme, comme attendu Aucun problème de...
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 required for scientific assessment were included in the application. The MAA was granted accelerated...