Valneva SE

Valneva Announces the Availability of Documentation for its Extraordinary General Meeting including Planned Changes to its Future Board of Directors

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Wednesday, November 15, 2023
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As part of the proposed changes, three current Supervisory Board members will not join the future Board of Directors, Ms. Johanna Pattenier, Ms. Sharon Tetlow and Mr. Frederic Grimaud, current Chairman of the Supervisory Board.

Key Points: 
  • As part of the proposed changes, three current Supervisory Board members will not join the future Board of Directors, Ms. Johanna Pattenier, Ms. Sharon Tetlow and Mr. Frederic Grimaud, current Chairman of the Supervisory Board.
  • I wish Valneva every success in the future,” said Frederic Grimaud, Valneva’s Chairman of the Board and Groupe Grimaud’s President and Chief Executive Officer.
  • The future Board of Directors is expected to elect a new chairperson during its constitutional post EGM meeting.
  • The Company also intends to propose additional, complementary Board of Directors members to its shareholders at its Annual General Meeting in June 2024.

Valneva Reports Positive Pivotal Phase 3 Immunogenicity Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate

Retrieved on: 
Monday, November 13, 2023
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Saint-Herblain (France), November 13, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive pivotal Phase 3 immunogenicity data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553.

Key Points: 
  • Saint-Herblain (France), November 13, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive pivotal Phase 3 immunogenicity data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553.
  • These results complement the initial Phase 3 safety data the Company reported for the trial in August 20231.
  • The pivotal immunogenicity data showed that a single-dose vaccination with VLA1553 induced a robust immune response in adolescents aged 12 to
  • An independent Data Safety Monitoring Board has continuously evaluated safety data during the trial and has not identified any safety concerns.

Valneva Announces U.S. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ®

Retrieved on: 
Friday, November 10, 2023
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Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.

Key Points: 
  • Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.
  • As sponsor of the first chikungunya vaccine approved in the U.S., Valneva has received a Priority Review Voucher (PRV) from the FDA, which it intends to monetize to help finance its research and development (R&D) programs.
  • With this U.S. approval, IXCHIQ® becomes the world’s first licensed chikungunya vaccine available to address this unmet medical need and the third vaccine Valneva1 has brought from early R&D to approval.
  • Initial safety data from this trial were included in the submission to the European Medicines Agency (EMA) in October 202313.

Valneva to Present and Hold Investor Meetings at the Jefferies London Healthcare Conference

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Tuesday, November 7, 2023
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Saint-Herblain (France), November 7, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and participate in 1-on-1 meetings with institutional investors at the Jefferies London Healthcare Conference, to take place November 14-16, 2023 in London, UK.

Key Points: 
  • Saint-Herblain (France), November 7, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and participate in 1-on-1 meetings with institutional investors at the Jefferies London Healthcare Conference, to take place November 14-16, 2023 in London, UK.
  • Chief Executive Officer Thomas Lingelbach and Chief Financial Officer Peter Bühler will host a fireside chat at 2:30pm GMT on November 14 to discuss Valneva’s commercial business and pipeline of infectious disease vaccines.
  • A replay of the webcast will be available following the live events in the “Investor” section of the Valneva website at www.valneva.com .
  • To request a meeting at the event, please contact your representative at Jefferies.

Valneva Submits Chikungunya Vaccine Marketing Application to EMA and Announces CHMP Accelerated Assessment

Retrieved on: 
Wednesday, October 25, 2023
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Saint-Herblain (France), October 25, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the submission of a marketing application with the European Medicines Agency (EMA) for approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553.

Key Points: 
  • Saint-Herblain (France), October 25, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the submission of a marketing application with the European Medicines Agency (EMA) for approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553.
  • Valneva was also granted accelerated assessment1 for the application by EMA’s Committee for Medicinal Products for Human Use (CHMP) based on the vaccine candidate’s “major interest for public health and therapeutic innovation”.
  • VLA1553 is currently the first and only chikungunya vaccine candidate worldwide for which regulatory review processes are underway.
  • Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “We welcome EMA’s accelerated assessment and will work closely with them to bring this vaccine to market.

Valneva to Present on Chikungunya at Several Leading Scientific Conferences

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Wednesday, October 11, 2023
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Saint-Herblain (France), October 11, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today it will present on the mosquito-borne chikungunya disease at several leading scientific conferences during the fourth quarter of 2023.

Key Points: 
  • Saint-Herblain (France), October 11, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today it will present on the mosquito-borne chikungunya disease at several leading scientific conferences during the fourth quarter of 2023.
  • At IDWeek, the annual meeting of the Infectious Diseases Society of America (IDSA), Valneva will support the roundtable discussion “Chikungunya is an Increasing Global Threat: The Need for Better Protection” taking place on October 14, 2023 at 6:00 pm Eastern Daylight Time (EDT) in Boston, Massachusetts.
  • At the American Society of Tropical Medicine and Hygiene (ASTMH) 2023 Annual Meeting in Chicago, Illinois, Valneva will hold two chikungunya presentations on October 20, 2023 at 11:00 am and 12:15 pm Central Daylight Time (CDT).
  • At the International Society of Vaccines Annual Congress taking place in Lausanne, Switzerland Valneva will present on chikungunya on October 24, 2023 at 09:45 am Central European Summer Time (CEST).

Valneva Announces New IXIARO® Supply Contract with the U.S. Government Worth a Minimum of $32 Million

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Monday, September 25, 2023
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Saint Herblain (France), September 25, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the signing of a new $32 million contract with the United States (U.S.) Department of Defense (DoD) for the supply of its Japanese encephalitis (JE) vaccine, IXIARO®.

Key Points: 
  • Saint Herblain (France), September 25, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the signing of a new $32 million contract with the United States (U.S.) Department of Defense (DoD) for the supply of its Japanese encephalitis (JE) vaccine, IXIARO®.
  • Under this new one-year contract, the DoD will buy a minimum of $32 million worth of IXIARO® vaccines and has the possibility to purchase additional doses during the coming twelve months.
  • Dipal Patel, Chief Commercial Officer of Valneva commented, “We are excited to continue our long-term relationship with the DoD.
  • In the U.S., Valneva markets and distributes IXIARO® directly to the military and private travel market.

Valneva and Pfizer Report Positive Pediatric and Adolescent Phase 2 Booster Results for Lyme Disease Vaccine Candidate

Retrieved on: 
Thursday, September 7, 2023
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Saint-Herblain (France) & New York, September 7, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) and Pfizer Inc. (NYSE: PFE) announced today positive pediatric and adolescent immunogenicity and safety data for their Lyme disease vaccine candidate, VLA15, when given as a booster.

Key Points: 
  • Saint-Herblain (France) & New York, September 7, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) and Pfizer Inc. (NYSE: PFE) announced today positive pediatric and adolescent immunogenicity and safety data for their Lyme disease vaccine candidate, VLA15, when given as a booster.
  • Lyme disease continues to spread, representing an important unmet medical need that impacts the lives of many people in the Northern Hemisphere.
  • With each new set of positive data, we come one step closer to potentially bringing this vaccine to both adults and children living in areas where Lyme disease is endemic.”
    The Phase 2 booster results emphasize the vaccine candidate’s potential to provide immunity against Lyme disease in pediatric and adolescent populations.
  • “Protection against Lyme disease is important for anyone who lives or spends time outdoors in areas where Lyme disease is endemic.

Valneva to Participate in Investor Conferences in the United States and Europe in September 2023

Retrieved on: 
Thursday, August 31, 2023
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Saint-Herblain (France), August 31, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that members of its senior leadership team are scheduled to participate in 1-on-1 meetings with institutional investors at the following investor conferences in September 2023.

Key Points: 
  • Saint-Herblain (France), August 31, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that members of its senior leadership team are scheduled to participate in 1-on-1 meetings with institutional investors at the following investor conferences in September 2023.
  • The Company will also discuss its existing commercial vaccine portfolio, which has been resuming strong revenue growth since the lifting of the COVID-19 travel restrictions.
  • Additionally, the Company will hold a live conference call and webcast for its first half 2023 financial results on Thursday September 21, 2023, at 3 p.m. CEST / 9 a.m. EDT.
  • To request a meeting, please contact your representative at the respective hosting banks.

Health Canada Accepts Valneva’s Chikungunya Vaccine License Application for Review

Retrieved on: 
Tuesday, August 29, 2023
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Based on Health Canada’s performance standard to process an NDS application, the Company believes the regulatory review could be completed by mid-2024.

Key Points: 
  • Based on Health Canada’s performance standard to process an NDS application, the Company believes the regulatory review could be completed by mid-2024.
  • This is the second regulatory application for VLA1553 filed by Valneva, and the Company intends to make additional regulatory submissions in 2023.
  • A Biologic License Application (BLA) is currently under priority review1 by the U.S. Food and Drug Administration (FDA)2.
  • VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway and, if approved, it could become the first licensed chikungunya vaccine available to address this unmet medical need.