Associated tags: Vaccine, Infection, Chikungunya, Lyme disease, VLA, Euronext Paris, Saint-Herblain, COVID-19, Pharmaceutical industry, EMA, Valneva SE, Vaccination
Locations: CANADA, DEERFIELD, SAN FRANCISCO, AMERICAS, SCOTLAND, UNITED STATES, NORTH AMERICA, NY, NEW YORK, GERMANY, NETHERLANDS, WASHINGTON, CALIFORNIA, EU, LYME, DOMINICAN REPUBLIC, HONDURAS, TD, MA, NANTES, FR, FRANCE, BRAZIL, EUROPE
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Vaccine 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.
Key Points:
- 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 Jaramillo M.D., Chief Medical Officer of Valneva, said, “We are pleased that these results are now fully available to the broader infectious disease community.
- Lyme disease is the most prevalent vector-borne infectious disease in North America and Europe, and we are excited about the ongoing trials and progress towards potentially offering a vaccine against this unmet medical need."
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Brazilian Health Regulatory Agency If approved, it will become the first chikungunya vaccine available in Europe to address this unmet medical need.
Key Points:
- If approved, it will become the first chikungunya vaccine available in Europe to address this unmet medical need.
- In accordance with the International Recognition Procedure (IRP)1, Valneva is also preparing a Marketing Authorization Application (MAA) for submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA).
- The CHMP opinion follows the November 2023 approval of IXCHIQ® by the US Food and Drug Administration (FDA)2.
- Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “This positive CHMP opinion marks a crucial milestone toward introducing a preventative solution against chikungunya in the EU.
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Senior Saint-Herblain (France), May 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the appointment of Dr. Hanneke Schuitemaker, Ph.D. as Chief Scientific Officer (CSO) and Executive Committee member, effective June 3, 2024.
Key Points:
- Saint-Herblain (France), May 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the appointment of Dr. Hanneke Schuitemaker, Ph.D. as Chief Scientific Officer (CSO) and Executive Committee member, effective June 3, 2024.
- Valneva decided to complement its Executive Team with an accomplished R&D leader to oversee the further evolution of the Company´s R&D portfolio.
- Specifically, Dr. Schuitemaker will focus on accelerating Valneva’s pre-clinical and translational R&D activities in support of the Company’s strategic ambition to provide first-, best- or only-in-class vaccine solutions.
- She has a unique and solid scientific background, which is notably reflected in more than 350 scientific publications.
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Ageing Saint-Herblain (France), May 7, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its financial results for the first quarter ending March 31, 2024, and provided corporate updates.
Key Points:
- Saint-Herblain (France), May 7, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its financial results for the first quarter ending March 31, 2024, and provided corporate updates.
- The condensed consolidated interim financial results are available on the Company’s website ( Financial Reports – Valneva ).
- In the first quarter of 2024, IXIARO®/JESPECT® sales were €16.6 million compared to €17.4 million in the first quarter of 2023.
- IXIARO®/JESPECT® sales were €16.6 million in the first quarter of 2024 compared to €17.4 million in the first quarter of 2023.
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Vaccine 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
Key Points:
- 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).
- The randomized, placebo-controlled, Phase 1 trial, VLA1601-102, is planned to enroll approximately 150 participants aged 18 to 49 years in the United States.
- Phase 1 results from Valneva’s first-generation Zika vaccine candidate were reported in 2018 showing a favorable safety profile and immunogenicity in all tested doses and schedules2.
- This preference stems from the understanding that the primary recipients of a Zika vaccine are anticipated to be women of childbearing age, potentially including those who are pregnant.
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).
Key Points:
- 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 Annual Financial Report, the Company's Annual Management Report, the Board of Directors’ Corporate Governance Report and the Company’s Sustainability Report.
- These documents are available on Valneva’s website ( https://valneva.com/investors/financial-reports/ ) and will also be available on the AMF ( www.amf-france.org/ ) and SEC ( www.sec.gov/ ) websites, respectively.
- Hard copies of these documents may be obtained from the Company, free of charge, upon request at the following address: 6 rue Alain Bombard, 44800 Saint-Herblain, France.
Control,
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The 24th The Company will have a display in the exhibit area of the congress at booth #433.
Key Points:
- The Company will have a display in the exhibit area of the congress at booth #433.
- There will be two sessions, from 11:40 to 12:20 EST and again from 12:30 to 1:10pm EST.
- Advisory Committee on Immunization Practices (ACIP)1 and these recommendations were adopted by the Centers for Disease Control and Prevention (CDC)2.
- Additionally, Valneva CEO Thomas Lingelbach will present the Best Production / Process Development award at the event.
Retrieved on:
Wednesday, March 20, 2024
Valneva reported Phase 1 results from its first-generation Zika vaccine candidate in 2019 showing excellent immunogenicity and safety results in all tested doses and schedules29.
Key Points:
- Valneva reported Phase 1 results from its first-generation Zika vaccine candidate in 2019 showing excellent immunogenicity and safety results in all tested doses and schedules29.
- Valneva recorded an operating loss of €82.1 million in 2023 compared to an operating loss of €113.4 million in 2022.
- In 2023, Valneva generated a net loss of €101.4 million compared to a net loss of €143.3 million in 2022.
- Cash at the end of 2023 does not include $103 million of proceeds from the PRV, which Valneva sold in February 2024.
Reimbursements of the first $100 million tranche will now start in January 2026 instead of July 2024.
Key Points:
- Reimbursements of the first $100 million tranche will now start in January 2026 instead of July 2024.
- Maturity of this first tranche will remain in the first quarter of 2027.
- Peter Bühler, Chief Financial Officer of Valneva, said, “We greatly appreciate the continued support from Deerfield and OrbiMed.
- Valneva announced amendments to the terms in January 20212 and upsizing in April 20223 and August 20234.
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.
Key Points:
- 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 Life Sciences Conference, held April 16 - 17, 2024, in Amsterdam, The Netherlands.
- VLA15, the Company’s Lyme disease vaccine candidate, is currently in Phase 3 clinical development and partnered with Pfizer for this study and global commercialization.
