Valneva obtains exclusive worldwide license for LimmaTech's S4V Shigella vaccine candidate and adds an attractive Phase 2 clinical asset to Valneva's R&D pipeline LimmaTech to receive upfront payment, is eligible for future milestone and royalty payments, and will collaborate on S4V clinical development through Phase 2 Valneva will host a live webcast on this announcement at 3 p.m. CEST/9 a.m. EDT today. Please refer to this link: https://edge.media-server.com/mmc/p/ck932u2n Saint-Herblain (France) and Schl ...

Valneva to receive up to $41.3 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 use in adults 18 years of age and older in the U.S., Canada and Europe CEPI will provide Valneva up to U.S. $41.3 million of additional funding over th ...

Significance of the IXCHIQ Vaccine Expanding Market Potential An additional marketing authorization application is under review by the Brazilian Health Regulatory Agency to make the vaccine available in certain low- and middle-income countries, with a potential approval in 2024. Valneva's latest approval from the EC turns out to be in favor of market growth. Valneva SE (VALN) recently announced that the European Commission (EC) has given it the marketing authorization for Valneva's single-dose Chikungunya v ...

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 ...