VLA

Valneva Confirms WHO Recommendations for its Inactivated COVID-19 Vaccine

Retrieved on: 
Tuesday, August 23, 2022
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Saint-Herblain (France), August 23, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, confirms today that the World Health Organization (WHO) has issued recommendations for use of the Companys inactivated COVID-19 vaccine.

Key Points: 
  • Saint-Herblain (France), August 23, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, confirms today that the World Health Organization (WHO) has issued recommendations for use of the Companys inactivated COVID-19 vaccine.
  • WHO may further update its interim recommendations to include additional uses of Valnevas COVID-19 vaccine as new data are made available.
  • Valneva currently has agreements to supply VLA2001 to certain EU Member States2 and the Kingdom of Bahrain3.
  • Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.

Valneva Initiates Rolling Submission of FDA Biologics License Application for its Single-Shot Chikungunya Vaccine Candidate

Retrieved on: 
Thursday, August 18, 2022
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Chikungunya is a major public health threat that continues to grow, and no vaccine or specific treatments are currently available for this debilitating disease.

Key Points: 
  • Chikungunya is a major public health threat that continues to grow, and no vaccine or specific treatments are currently available for this debilitating disease.
  • This rolling BLA submission is part of the accelerated approval pathway agreed upon with the FDA in 20204.
  • Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes.
  • VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 120 countries.

Valneva Provides Update on IXIARO® Supply Contract with U.S. Department of Defense

Retrieved on: 
Thursday, August 18, 2022
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Due to the past and ongoing impact of the COVID-19 pandemic on its operations, the DoD considers its existing IXIARO supply levels sufficient to meet current needs.

Key Points: 
  • Due to the past and ongoing impact of the COVID-19 pandemic on its operations, the DoD considers its existing IXIARO supply levels sufficient to meet current needs.
  • The DoD has communicated an interest in negotiating a new supply contract in 2023, once inventory returns to standard levels.
  • The DoD has relied on IXIARO since 2010 to help protect personnel who are deployed to JE endemic areas, for whom JE vaccination is recommended.
  • Thomas Lingelbach, President and Chief Executive Officer of Valneva, commented: We thank the DoD for their partnership and look forward to further contract negotiations in the future.

Valneva Establishes an At-the-Market (ATM) Program on Nasdaq

Retrieved on: 
Monday, August 15, 2022
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Only eligible investors (as described in greater detail below) may purchase ADSs under the ATM Program.

Key Points: 
  • Only eligible investors (as described in greater detail below) may purchase ADSs under the ATM Program.
  • The new ordinary shares will be admitted to trading on the regulated market of Euronext in Paris and the issued ADSs will trade on the Nasdaq Global Select Market (Nasdaq).
  • No offers or sales of ADSs under the ATM Program can be made until the Registration Statement is declared effective by the SEC.
  • This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the proposed ATM Program and the expected use of proceeds, if any, from the ATM Program.

Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15

Retrieved on: 
Monday, August 8, 2022
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The randomized, placebo-controlled, Phase 3 VALOR study is planned to enroll approximately 6,000 participants 5 years of age and older.

Key Points: 
  • The randomized, placebo-controlled, Phase 3 VALOR study is planned to enroll approximately 6,000 participants 5 years of age and older.
  • As per the terms of the collaboration agreement between Pfizer and Valneva, Pfizer will make a $25 million milestone payment to Valneva upon initiation of the Phase 3 study.
  • VLA15 is the only Lyme disease vaccine candidate currently in clinical development.
  • This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease.

Valneva Confirms Amendment of Advance Purchase Agreement with European Commission for Valneva’s Inactivated COVID-19 Vaccine

Retrieved on: 
Monday, August 1, 2022
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Under this amendment, the Member States purchases of VLA2001, Valnevas inactivated whole-virus COVID-19 vaccine, consist of 1.25 million doses of VLA2001 in 2022, with the option to purchase an equivalent quantity later this year for delivery in 2022.

Key Points: 
  • Under this amendment, the Member States purchases of VLA2001, Valnevas inactivated whole-virus COVID-19 vaccine, consist of 1.25 million doses of VLA2001 in 2022, with the option to purchase an equivalent quantity later this year for delivery in 2022.
  • The Company expects to deliver the first vaccine doses to participating EU Member States (Germany, Austria, Denmark, Finland, and Bulgaria) in the coming weeks.
  • VLA2001 is produced on Valnevas established Vero-cell platform, leveraging the manufacturing technology for Valnevas licensed Japanese encephalitis vaccine, IXIARO.
  • Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.

European Commission Approves Purchase Agreement Amendment for Valneva’s Inactivated COVID-19 Vaccine

Retrieved on: 
Wednesday, July 20, 2022
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Saint-Herblain (France), July 20, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that the European Commission (EC) has approved an amendment to the Advance Purchase Agreement (APA) it signed in November 20211 for Valnevas inactivated whole-virus COVID-19 vaccine, VLA2001.

Key Points: 
  • Saint-Herblain (France), July 20, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that the European Commission (EC) has approved an amendment to the Advance Purchase Agreement (APA) it signed in November 20211 for Valnevas inactivated whole-virus COVID-19 vaccine, VLA2001.
  • The first vaccine doses will be delivered to participating EU Member States (Germany, Austria, Denmark, Finland and Bulgaria) in the coming weeks.
  • Despite this, we have decided to enter into this amendment to make our vaccine available to the Europeans who have been waiting for it.
  • VLA2001 is produced on Valnevas established Vero-cell platform, leveraging the manufacturing technology for Valnevas licensed Japanese encephalitis vaccine, IXIARO.

Valneva Receives Positive CHMP Opinion for Marketing Authorization of its Inactivated COVID-19 Vaccine Candidate in Europe

Retrieved on: 
Thursday, June 23, 2022
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The European Commission (EC) will review the CHMP recommendation, and a decision on the marketing authorization application for VLA2001 is expected shortly.

Key Points: 
  • The European Commission (EC) will review the CHMP recommendation, and a decision on the marketing authorization application for VLA2001 is expected shortly.
  • If granted, this will be the first COVID-19 vaccine to receive a standard marketing authorization in Europe.
  • Thomas Lingelbach, Chief Executive Officer of Valneva, commented, We are pleased that the CHMP has recommended VLA2001, the only inactivated COVID-19 vaccine candidate in Europe, for full marketing authorization and are now looking forward to receiving marketing authorization from the EC.
  • VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe.

Valneva and Pfizer Enter into an Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15

Retrieved on: 
Monday, June 20, 2022
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Valneva is planning to use the proceeds from Pfizers equity investment to support its Phase 3 development contribution to the Lyme disease program.

Key Points: 
  • Valneva is planning to use the proceeds from Pfizers equity investment to support its Phase 3 development contribution to the Lyme disease program.
  • In addition, Valneva and Pfizer updated the terms of their collaboration and license agreement which they announced on April 30, 20201.
  • Valneva will now fund 40% of the remaining shared development costs compared to 30% in the initial agreement.
  • Pfizer will pay Valneva tiered royalties ranging from 14% to 22%, compared to royalties starting at 19% in the initial agreement.

Valneva and Pfizer Enter into an Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15

Retrieved on: 
Monday, June 20, 2022
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Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE) today announced that they have entered into an Equity Subscription Agreement and have updated the terms of their Collaboration and License Agreement for Lyme disease vaccine candidate VLA15.

Key Points: 
  • Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE) today announced that they have entered into an Equity Subscription Agreement and have updated the terms of their Collaboration and License Agreement for Lyme disease vaccine candidate VLA15.
  • Valneva is planning to use the proceeds from Pfizers equity investment to support its Phase 3 development contribution to the Lyme disease program.
  • In addition, Valneva and Pfizer updated the terms of their collaboration and license agreement which they announced on April 30, 20201.
  • Pfizer will pay Valneva tiered royalties ranging from 14% to 22%, compared to royalties starting at 19% in the initial agreement.