Saint-Herblain

Valneva Initiates Phase 1 Trial of Second-Generation Zika Vaccine Candidate

Retrieved on: 
Tuesday, March 26, 2024
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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.

Valneva Announces Filing of 2023 Universal Registration Document and US Form 20-F

Retrieved on: 
Monday, March 25, 2024
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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.

Valneva to Present on its Chikungunya Vaccine IXCHIQ®, Participate in Multiple Events at the 24th World Vaccine Congress in Washington D.C.

Retrieved on: 
Thursday, March 21, 2024
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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.

Valneva Announces Extension of the Interest-Only Period of Its Debt Facility with Deerfield and OrbiMed

Retrieved on: 
Monday, March 18, 2024
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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.

Valneva to Present at Upcoming TD Cowen and Van Lanschot Kempen Healthcare Investor Conferences

Retrieved on: 
Monday, March 4, 2024
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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.

U.S. CDC Advisory Committee (ACIP) Recommends Use of Valneva’s Single-Dose Chikungunya Vaccine IXCHIQ®

Retrieved on: 
Thursday, February 29, 2024
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ACIP recommends IXCHIQ® for persons aged ≥18 years traveling to a country or territory where there is a chikungunya outbreak.

Key Points: 
  • ACIP recommends IXCHIQ® for persons aged ≥18 years traveling to a country or territory where there is a chikungunya outbreak.
  • ACIP also recommended chikungunya vaccination for laboratory workers with potential for exposure to CHIKV.
  • IXCHIQ offers advantages to travelers on vacation and visiting family and to people engaged in business ventures, missions, or laboratory duties.
  • We embrace the ACIP endorsement, marking IXCHIQ® as the only approved and recommended vaccine for the target population.

Valneva Announces Sale of Priority Review Voucher for $103 Million

Retrieved on: 
Monday, February 5, 2024
VLA, PRV, Chikungunya, FDA, Euronext Paris, Saint-Herblain, Food, Disease, Vaccine, Risk, Lyme disease, Sale, Priority review, U.S. FDA, Pharmaceutical industry

Saint-Herblain (France), February 5, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced it sold the Priority Review Voucher (PRV) it received from the U.S. Food and Drug Administration (FDA) for $103 million (€95 million).

Key Points: 
  • Saint-Herblain (France), February 5, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced it sold the Priority Review Voucher (PRV) it received from the U.S. Food and Drug Administration (FDA) for $103 million (€95 million).
  • With this approval, IXCHIQ® became the world’s first licensed chikungunya vaccine available to address this unmet medical need.
  • As shown with the recent approval of our chikungunya vaccine, we remain committed to growing our portfolio of vaccines addressing unmet medical needs which have the potential to transform people’s lives.”
    Under the tropical Disease Priority Review Voucher Program, FDA awards priority review vouchers to sponsors of tropical disease product applications that meet certain criteria.
  • PRVs can be redeemed to receive priority review of a subsequent marketing application for a different product, sold or transferred.

Valneva Vaccinates First Participant in Pediatric Trial of Single-Shot Chikungunya Vaccine

Retrieved on: 
Wednesday, January 10, 2024
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Saint-Herblain (France), January 10, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that the first participant has been vaccinated in the Phase 2 clinical trial evaluating the safety and Immunogenicity in children of two different dose levels of Valneva’s single-shot chikungunya vaccine.

Key Points: 
  • Saint-Herblain (France), January 10, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that the first participant has been vaccinated in the Phase 2 clinical trial evaluating the safety and Immunogenicity in children of two different dose levels of Valneva’s single-shot chikungunya vaccine.
  • There is currently no approved chikungunya vaccine for children and Valneva’s vaccine IXCHIQ® is currently the only licensed chikungunya vaccine2 to address this unmet medical need in adults aged 18 years and older who are at increased risk of exposure to the virus.
  • Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “This pediatric trial is extremely important.
  • Given the significant threat that chikungunya poses to individuals living in or traveling to endemic areas, it is crucial to make the vaccine accessible to all age groups.

Valneva to Conduct Investor Meetings during the J.P. Morgan Healthcare Conference and Oddo BHF Forum

Retrieved on: 
Thursday, January 4, 2024
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Saint-Herblain (France), January 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that members of its management team including Thomas Lingelbach, CEO and Peter Bühler, CFO will hold investor meetings during the 42nd Annual J.P. Morgan Healthcare Conference, January 8 – 10, 2024 in San Francisco and virtually at the Oddo BHF Forum on January 15,2024.

Key Points: 
  • Saint-Herblain (France), January 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that members of its management team including Thomas Lingelbach, CEO and Peter Bühler, CFO will hold investor meetings during the 42nd Annual J.P. Morgan Healthcare Conference, January 8 – 10, 2024 in San Francisco and virtually at the Oddo BHF Forum on January 15,2024.
  • Valneva’s CEO and CFO will notably discuss the Company’s advanced vaccine development pipeline, including its Lyme disease vaccine candidate VLA15 (Phase 3 fully enrolled, partnered with Pfizer), as well as the Company’s growing commercial business, which now includes recently FDA-approved1 IXCHIQ®, the world’s first licensed vaccine for prevention of disease caused by chikungunya virus, launching in early 2024.
  • To schedule a 1on1 investor meeting with Valneva, institutional investors and analysts can

Valneva Provides Updated 2023 Financial Guidance

Retrieved on: 
Friday, December 29, 2023
Risk, U.S. FDA, Euronext Paris, Sale, Saint-Herblain, FDA, Disease, PRV, COVID-19, Chikungunya, VLA

Saint-Herblain (France), December 29, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Company is modifying its financial guidance for 2023.

Key Points: 
  • Saint-Herblain (France), December 29, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Company is modifying its financial guidance for 2023.
  • Product sales guidance remains unchanged, as do anticipated R&D expenses.
  • The Company’s previous guidance included expected total revenues and other income between €220 million and €260 million1.
  • Peter Bühler, Chief Financial Officer of Valneva, said, “We remain confident in our ability to sell our priority review voucher successfully at a price within the previously suggested range.