Saint-Herblain

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.

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

Retrieved on: 
Monday, August 28, 2023
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Saint-Herblain (France), August 28, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive initial Phase 3 safety data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553.

Key Points: 
  • Saint-Herblain (France), August 28, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive initial Phase 3 safety data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553.
  • An independent DSMB has continuously evaluated safety data during the trial and has not identified any safety concerns.
  • Importantly, the initial data suggest a favorable safety profile in seropositive participants, confirming the observations following re-vaccination of individuals in Phase 1 trial VLA1553-1011.
  • If approved, VLA1553 could become the first licensed chikungunya vaccine available to address this unmet medical need.

Valneva Announces Extension of Existing Loan Agreement

Retrieved on: 
Thursday, August 17, 2023
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Saint-Herblain (France), August 17, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced an agreement to increase the principal amount of its existing $100 million senior secured debt financing agreement with funds managed by leading U.S. healthcare investment firms Deerfield Management Company and OrbiMed.

Key Points: 
  • Saint-Herblain (France), August 17, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced an agreement to increase the principal amount of its existing $100 million senior secured debt financing agreement with funds managed by leading U.S. healthcare investment firms Deerfield Management Company and OrbiMed.
  • The add-on loan facility provides Valneva with immediate access to $50 million, with an additional $50 million available at the Company’s discretion until December 31, 2023.
  • The original loan agreement was signed in February 20201.
  • Valneva announced amendments to the terms in January 20212 and upsizing in April 20223.

Valneva Announces PDUFA Date Extension for Chikungunya Virus Vaccine Candidate

Retrieved on: 
Monday, August 14, 2023
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The FDA extended the PDUFA date to allow sufficient time to align and agree on the phase 4 program necessary under the accelerated approval pathway.

Key Points: 
  • The FDA extended the PDUFA date to allow sufficient time to align and agree on the phase 4 program necessary under the accelerated approval pathway.
  • Valneva is committed to working with the FDA in its ongoing review of the BLA, and to potentially delivering the world’s first chikungunya vaccine.
  • This PDUFA extension does not impact Valneva’s current regulatory submission in Canada or its planned submission with the European Medicines Agency (EMA).
  • We are continuing to work closely and collaboratively with the FDA, and we believe it may be possible to obtain an approval before the new PDUFA date.”

Valneva Supervisory Board Recommends Transition from a Two-Tier Governance Model to a Board of Directors

Retrieved on: 
Thursday, June 22, 2023
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Saint-Herblain (France), June 22, 2023 – Valneva S E (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its Supervisory Board has recommended a change of governance model.

Key Points: 
  • Saint-Herblain (France), June 22, 2023 – Valneva S E (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its Supervisory Board has recommended a change of governance model.
  • The Company’s Supervisory Board members voted in favor of recommending to the shareholders to transition from the Company’s current two-tier governance model, which includes a Supervisory Board and a Management Board, to a one-tier model led by a Board of Directors, with CEO Thomas Lingelbach included as an executive member.
  • The Supervisory Board’s proposal also recommends the establishment of an Executive Committee to be comprised of, among others, the members of the current Management Board.
  • This proposed change in Valneva’s governance structure will be submitted to the vote of the Company’s shareholders at an Extraordinary General Meeting later this year.

  Valneva Announces Successful Outcome of its AGM and the Appointment of Pfizer’s Former Vaccine R&D Head to its Supervisory Board

Retrieved on: 
Wednesday, June 21, 2023
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Dr Kathrin U Jansen, Ph.D., a German national with over 30 years of vaccine R&D experience, was appointed to Valneva’s Supervisory Board for a three-year term.

Key Points: 
  • Dr Kathrin U Jansen, Ph.D., a German national with over 30 years of vaccine R&D experience, was appointed to Valneva’s Supervisory Board for a three-year term.
  • Prior to Wyeth, Dr. Jansen spent 12 years at Merck Research Laboratories supporting several vaccine efforts and leading the R&D activities of Gardasil®, the world’s first cervical cancer vaccine.
  • Additionally, the term of office of Supervisory Board members Ms. Johanna W. Pattenier and Ms. Sharon E. Tetlow was renewed until June 2026.
  • The AGM’s voting results will be made available in the “ Investors & Media ” section of Valneva’s corporate website in the coming days.

Valneva Announces Publication of its Chikungunya Vaccine Candidate Phase 3 Data in The Lancet

Retrieved on: 
Tuesday, June 13, 2023
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Saint-Herblain (France), June 13, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that the Company’s pivotal Phase 3 data for its single-shot chikungunya vaccine candidate, VLA1553, have been published in The Lancet , the world’s leading peer-reviewed medical journal.

Key Points: 
  • Saint-Herblain (France), June 13, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that the Company’s pivotal Phase 3 data for its single-shot chikungunya vaccine candidate, VLA1553, have been published in The Lancet , the world’s leading peer-reviewed medical journal.
  • This immunogenicity profile was similar in both younger and older adults, and 96% of participants maintained seroresponse six months after vaccination.
  • VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway.
  • If approved, VLA1553 could become the first licensed chikungunya vaccine available to address this unmet medical need.

Valneva Announces the Availability of Documentation for its Shareholder Meeting

Retrieved on: 
Wednesday, May 31, 2023
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The preliminary Notice of Meeting, containing the agenda, the draft resolutions and instructions for participation and voting, was published in the French Bulletin des Annonces Légales Obligatoires (BALO) on May 15, 2023.

Key Points: 
  • The preliminary Notice of Meeting, containing the agenda, the draft resolutions and instructions for participation and voting, was published in the French Bulletin des Annonces Légales Obligatoires (BALO) on May 15, 2023.
  • Documents and information relating to the Meeting are available on Valneva’s website (www.valneva.com) in the “Investors/General Meetings” section.
  • Shareholders can also obtain the Combined General Meeting documents upon request to the Company by sending an email to the following address: [email protected] .
  • The Company also recommends that shareholders regularly consult the Combined General Meeting section of its website, www.valneva.com.

Valneva to Present and Hold Investor Meetings at Upcoming Conferences in June

Retrieved on: 
Wednesday, May 31, 2023
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Valneva will also discuss its Phase 3 Lyme disease vaccine candidate (VLA15) and its currently commercialized vaccine products during the conferences.

Key Points: 
  • Valneva will also discuss its Phase 3 Lyme disease vaccine candidate (VLA15) and its currently commercialized vaccine products during the conferences.
  • Jefferies Healthcare Conference: Peter Buhler, Chief Financial Officer of Valneva will present on Wednesday, June 7, 2023, at 1.30pm ET.
  • A replay of the webcast will be available following the live events in the “Investor” section of the Valneva website at www.valneva.com .
  • Goldman Sachs Annual Global Healthcare Conference: The Company will be available for 1on1 investor meetings.