Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, "The EC approval marks a crucial milestone toward making this vaccine available to as many European citizens as possible. In recent years, climate change has caused the Aedes mosquito, a known carrier of chikungunya and dengue viruses, to spread to areas in Europe that were previously unaffected. It is critical to provide a vaccine solution not only to European travelers going to endemic chikungunya areas, such as South America or Afr ...

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. The approval was unanimously endorsed by Member States following a stringent assessment by the European Medicines Agency (EMA)1. The EC decision marks ...

Ms. Danièle Guyot-Caparros was appointed to Valneva's Board of Directors for a three-year term. Ms. GuyotCaparros has a proven track record in finance and business operations. She started her career in Audit and Corporate Finance with PWC specializing in the Chemical/Pharma Industry. In 1992, she joined RhônePoulenc-Rorer (later Aventis and Sanofi) where she held several senior finance positions (CFO Global R&D, CFO Europe, Group Planning). She also held responsibilities in business development, pricing, an ...

Core Insights - Valneva SE has received approval for its single-dose chikungunya vaccine, IXCHIQ, from Health Canada, following similar approvals from the FDA and the European Medicines Agency [1][11][18] - The chikungunya virus, transmitted by Aedes mosquitoes, poses significant health risks, and the approval of IXCHIQ addresses an unmet medical need for travelers to endemic regions [2][4][10] Expanding Market Potential - Over 50 million North Americans, including approximately 7 million Canadians, travel to chikungunya-endemic regions annually, indicating a substantial market potential for IXCHIQ [4] - The approval positions Valneva to significantly impact the chikungunya vaccine market globally, with plans to launch in Canada in Q4 2024 [16][18] Addressing Global Health Challenges - The vaccine's approval is critical in combating the public health threat posed by chikungunya, especially as climate change increases the spread of Aedes mosquitoes [10][17] - Valneva's global strategy includes collaborations with CEPI and Instituto Butantan to enhance vaccine accessibility in low- and middle-income countries, supported by a funding agreement with CEPI [12] Efficacy and Durability - The pivotal Phase 3 study published in The Lancet showed a 98.9% seroresponse rate 28 days post-vaccination, with 96.3% of participants sustaining this immune response for six months [11]

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. This decision marks the second approval the Company has received for IXCHIQ® following approval from the U.S. Food and Drug Administration (FDA) in November 2023. The European Medicines Agency (EMA) also ...

Core Insights - Health Canada's approval of IXCHIQ® marks a significant advancement in combating the chikungunya virus, which is increasingly prevalent due to climate change, with hundreds of thousands of cases reported in the Americas, South Asia, and Africa this year [1][6][10] - Valneva, a specialty vaccine company, is focused on developing and commercializing vaccines for infectious diseases, with IXCHIQ® being the only licensed chikungunya vaccine available [2][11] - The vaccine is expected to be commercially available in Canada by Q4 2024, following its recent approval in the U.S. and a pending decision from the European Medicines Agency [6][8] Company Overview - Valneva SE is a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases, addressing unmet medical needs [2][11] - The company has a strong track record in advancing vaccines from early R&D to approvals and currently markets three proprietary travel vaccines, including IXCHIQ® [11] Vaccine Details - IXCHIQ® is intended for active immunization in individuals aged 18 and older, providing a single-dose immunization against chikungunya virus [4][6] - The pivotal Phase 3 study published in The Lancet demonstrated a 98.9% seroresponse rate at 28 days post-vaccination, with 96.3% of participants maintaining this immune response for six months [7][10] Market and Accessibility - Valneva is collaborating with CEPI and Instituto Butantan to enhance vaccine accessibility in low- and middle-income countries, with funding of up to $24.6 million from the European Union's Horizon 2020 program [8][9] - The chikungunya virus has been identified in over 110 countries, with more than 3.7 million cases reported in the Americas between 2013 and 2023, indicating a significant public health concern [10]

Saint-Herblain (France), June 5, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company ("the Company"), today announced the availability of documentation for its Combined General Meeting ("the Meeting") to be held on June 26, 2024 at 2:00 p.m. CEST at the Sofitel Lyon Bellecour Hotel, 20 quai du Docteur Gailleton, 69002 Lyon (France). The Preliminary Notice of Meeting – including the agenda, the draft resolutions proposed by the Board of Directors, and instructions for participation and vo ...

Group 1 - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [4][6] - The company is advancing multiple vaccine candidates, including VLA15, the leading Lyme Disease vaccine in Phase 3 development partnered with Pfizer, and VLA1601, a second-generation Zika virus vaccine in Phase 1 clinical development [2][6] - Valneva's commercial business includes the ongoing launch of IXCHIQ®, the first and only approved chikungunya vaccine, contributing to the funding of its vaccine pipeline [2][6] Group 2 - Valneva will participate in several investor conferences in June 2024, including the Jefferies Global Healthcare Conference and the Goldman Sachs 45th Annual Global Healthcare Conference, to discuss its vaccine candidates and commercial strategies [3] - Institutional investors are invited to request one-on-one meetings with management during these conferences [3]

Core Insights - Valneva SE is actively participating in several investor conferences in June 2024 to discuss its vaccine candidates and commercial business [1][2] Group 1: Vaccine Development - Valneva is developing VLA15, the leading Lyme Disease vaccine candidate, which is currently in Phase 3 development and partnered with Pfizer [2][6] - The company is also advancing VLA1601, a second-generation Zika virus vaccine candidate, which is in Phase 1 clinical development [2][6] Group 2: Commercial Business - Valneva is launching IXCHIQ®, the first and only approved chikungunya vaccine, as part of its growing commercial business [2][6] - The revenues from the commercial business are supporting the advancement of the vaccine pipeline, including the Lyme disease and Zika virus vaccine candidates [6] Group 3: Investor Engagement - Institutional investors can request one-on-one meetings with management at various conferences, including the Jefferies Global Healthcare Conference and Goldman Sachs 45th Annual Global Healthcare Conference [3] - The conferences will feature formats such as fireside chats and investor meetings, providing opportunities for direct engagement with the company's management [3] Group 4: Company Overview - Valneva is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases [4] - The company has a strong track record of advancing multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [5]

Saint-Herblain (France), June 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the results of two Phase 2 clinical trials of Lyme disease vaccine candidate, VLA15, were published in the peer-reviewed medical journal, The Lancet Infectious Diseases. These trials, as well as a third Phase 2 trial in pediatric participants, supported the design of the current pivotal Phase 3 trial, 'Vaccine Against Lyme for Outdoor Recreationists' (VALOR). Juan Carlos ...