VALNEVA SE WKN: A0MVJZ ISIN: FR0004056851 Kürzel: VLA Forum: Aktien Thema: Hauptdiskussion

Was man Valneva mal zu Gute halten muss (kann gar nicht glauben das ich so etwas sage) - wir halten uns "relativ" OK betrachtet man mal den Gesamtmarkt die letzten Wochen.

wenn bis ende April keine Zulassung - sind wir bei 2.xx - sowas von sinnlos hier

ich versteh auch VAL nicht, warum sie immer wieder Zeiten der Zulassung nennen (.. im letzt.Quartal 2024 erwartet, im 1. Qu. 25 erwartet usw), am Besten gar nichts melden uns sich "überraschen" lassen

Ist ja eh immer so dass sie die Leute anzuckern wollen mit einer Einreichung um dann später was negatives zu melden

Vielleicht kommt später noch eine Meldung. Wegen der Zeitverschiebung....😴

6 Valneva Responds to French Government's Call for Vaccine Supply of IXCHIQ® against Chikungunya Outbreak in La Réunion - Valneva (https://valneva.com/press- release/valneva-responds-to-french-governments-call-for-vaccine-supply-of- ixchiq-against-chikungunya-outbreak-in-la-reunion/) 7 Valneva Reports Further Positive Pivotal Phase 3 Data in Adolescents for its Single-Shot Chikungunya Vaccine - Valneva (https://valneva.com/press- release/valneva-reports-further-positive-pivotal-phase-3-data-in-adolescents- for-its-single-shot-chikungunya-vaccine/) 8 Valneva Reports High Sustained Immune Response in Adolescents One Year After Single Vaccination with its Chikungunya Vaccine - Valneva (https://valneva.com/press-release/valneva-reports-high-sustained-immune- response-in-adolescents-one-year-after-single-vaccination-with-its-chikungunya- vaccine/) 9 CEPI Expands Partnership with Valneva with a $41.3 Million Grant to Support Broader Access to the World's First Chikungunya Vaccine - Valneva (https://valneva.com/press-release/cepi-expands-partnership-with-valneva-with-a- 41-3-million-grant-to-support-broader-access-to-the-worlds-first-chikungunya- vaccine/) 10 Valneva Successfully Expands Access to Asia for its Chikungunya Vaccine with Serum Institute of India - Valneva (https://valneva.com/press-release/valneva- successfully-expands-access-to-asia-for-its-chikungunya-vaccine-with-serum- institute-of-india/) 11 https://jvi.asm.org/content/jvi/88/20/11644.full.pdf 12 https://cmr.asm.org/content/31/1/e00104-16 13 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-

1 Valneva Receives Marketing Authorization in the UK for the World's First Chikungunya Vaccine, IXCHIQ® - Valneva (https://valneva.com/press- release/valneva-receives-marketing-authorization-in-the-uk-for-the-worlds-first- chikungunya-vaccine-ixchiq/) 2 Valneva Receives EMA's Positive CHMP Opinion for Adolescent Label Extension for Chikungunya Vaccine IXCHIQ (https://valneva.com/press-release/valneva- receives-emas-positive-chmp-opinion-for-adolescent-label-extension-for- chikungunya-vaccine-ixchiq/)(®) (https://valneva.com/press-release/valneva- receives-emas-positive-chmp-opinion-for-adolescent-label-extension-for- chikungunya-vaccine-ixchiq/) - Valneva (https://valneva.com/press- release/valneva-receives-emas-positive-chmp-opinion-for-adolescent-label- extension-for-chikungunya-vaccine-ixchiq/) 3 Valneva Announces U.S. FDA Approval of World's First Chikungunya Vaccine, IXCHIQ (https://valneva.com/press-release/valneva-announces-u-s-fda-approval-of- worlds-first-chikungunya-vaccine-ixchiq/)(®) (https://valneva.com/press- release/valneva-announces-u-s-fda-approval-of-worlds-first-chikungunya-vaccine- ixchiq/) - Valneva (https://valneva.com/press-release/valneva-announces-u-s-fda- approval-of-worlds-first-chikungunya-vaccine-ixchiq/) 4 Valneva Receives Marketing Authorization in Europe for the World's First Chikungunya Vaccine, IXCHIQ (https://valneva.com/press-release/valneva-receives- marketing-authorization-in-europe-for-the-worlds-first-chikungunya-vaccine- ixchiq/)(®) (https://valneva.com/press-release/valneva-receives-marketing- authorization-in-europe-for-the-worlds-first-chikungunya-vaccine-ixchiq/) - Valneva (https://valneva.com/press-release/valneva-receives-marketing- authorization-in-europe-for-the-worlds-first-chikungunya-vaccine-ixchiq/) 5 Valneva Announces Health Canada Approval of the World's First Chikungunya Vaccine, IXCHIQ (https://valneva.com/press-release/valneva-announces-health- canada-approval-of-the-worlds-first-chikungunya-vaccine-ixchiq/)(®) (https://valneva.com/press-release/valneva-announces-health-canada-approval-of- the-worlds-first-chikungunya-vaccine-ixchiq/) - Valneva

large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas(12). Between 2013 and 2023, more than 3.7 million cases were reported in the Americas(13) and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem.(14) About Valneva SE We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions. We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world's first chikungunya vaccine, as well as certain third-party vaccines. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world's most clinically advanced tetravalent Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at www.valneva.com (http://www.valneva.com).

Valneva is focused on expanding the vaccine's label and access. Label extension applications to adolescent were submitted in Europe, the United-States, Canada and the UK based on positive six-month adolescent Phase 3 data which showed that a single-dose vaccination with IXCHIQ(®) induces a high and sustained immune response in 99.1% of adolescents, and that the vaccine was generally well tolerated(7). Valneva reported further positive Phase 3 data in adolescents earlier this year, which showed a sustained 98.3% sero-response rate one-year after single vaccination with IXCHIQ(®)(8). The Lancet Infectious Diseases, a world leading infectious diseases journal, also published an article (https://www.thelancet.com/journals/laninf/article/PIIS1473- 3099(24)00458-4/abstract) showing that the vaccine was well tolerated in adolescents aged 12 to 17 years 28 days after a single injection, regardless of previous chikungunya virus (CHIKV) infection. Additionally, in the third quarter of 2024, the Company expanded its partnership with the Coalition for Epidemic Preparedness (CEPI)(9), with support from the EU Horizon Europe program, through a $41.3 million grant to advance broader access to the vaccine in Low- and Middle-Income Countries (LMICs), post-marketing studies and research to support potential label extensions in children, adolescents and pregnant women. Within the framework of this partnership, Valneva recently announced the signing of an exclusive license agreement with the Serum Institute of India (SII)(10), the world's largest manufacturer of vaccines by number of doses, enabling the supply of the vaccine in Asia, with a commitment to priority supply of the chikungunya vaccine at an affordable price to public health markets in LMICs. This new agreement complements the license agreement Valneva signed in 2021 with Instituto Butantan in Brazil for the development, manufacturing and marketing of a local chikungunya vaccine at an affordable price for distribution in Latin American countries and selected LMICs affected by the disease. About Chikungunya Chikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years(11).

Saint Herblain (France), March 31, 2025 - Valneva SE (https://valneva.com/?lang=fr) (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted a label extension application to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) to potentially expand the use of its chikungunya vaccine, IXCHIQ(®), currently approved in adults(1), to adolescents aged 12 to 17 years in the UK. This submission follows the recent positive opinion of the European Medicines Agency (EMA) on extension of IXCHIQ(®) label to adolescents in the European Union (EU)(2). IXCHIQ(®) is the world's first licensed chikungunya vaccine available to address this significant unmet medical need. It is approved in the U.S.(3), Europe(4), Canada(5) and the UK for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. Chikungunya has become an increasingly pressing public health issue, with outbreaks currently ongoing in India, Brazil and the French Island of La Réunion. Valneva announced last week that it has responded to the French government's call for supply of IXCHIQ(®) in La Réunion and that it will provide 40,000 doses to the Island's wholesalers, with an option to provide more(6). Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, 'Given the substantial risk that chikungunya presents to people residing in or traveling to endemic regions, it's imperative to ensure the vaccine is available to all age groups. Broader accessibility would certainly help provide protection and mitigate the burden of this debilitating illness, which is currently spreading in areas that were previously unaffected. The long-term durability of the immune response is also extremely important, especially for endemic countries where access to immunization can be difficult.'

Für die Messdiener unter uns sollte es jemand auf Latein posten. 🙏

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Ja aber wo bleibt die Brasilienzulassung? Quartalsende haben wir. :(

Valneva press release, da steht es

Guten Morgen was für Neuigkeiten gibt es?