Valneva SE

Valneva Continues Ongoing Discussions with the European Commission for Inactivated COVID-19 Vaccine Candidate

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星期四, 七月 1, 2021
Medical research, Medical specialties, Health sciences, Medicine, Valneva SE, Vaccination, Virology, Clinical trials, COVID-19 vaccine, Vaccine, VLA2001, Vaxart

Saint-Herblain (France), July 1, 2021 Following a media article published yesterday, Valneva SE , (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, indicated today it continues ongoing discussions with the European Commission regarding VLA2001, Valnevas inactivated COVID-19 vaccine candidate.

Key Points: 
  • Saint-Herblain (France), July 1, 2021 Following a media article published yesterday, Valneva SE , (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, indicated today it continues ongoing discussions with the European Commission regarding VLA2001, Valnevas inactivated COVID-19 vaccine candidate.
  • Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.
  • We take a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options.
  • We then apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, as well as our established vaccine development capabilities, to develop prophylactic vaccines to address these diseases.

Valneva Announces Successful Outcome of its AGM

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星期三, 六月 23, 2021
Valneva SE, Medical specialties, Vaccination, Virology, Medical research, Medicine, Health sciences, COVID-19 vaccine, Vaccine, VLA2001

Valneva also confirmed at its AGM that it expects to announce topline data for the Phase 3 trials of its single-shot chikungunya vaccine candidate this summer and of its inactivated COVID-19 vaccine candidate by September 2021.

Key Points: 
  • Valneva also confirmed at its AGM that it expects to announce topline data for the Phase 3 trials of its single-shot chikungunya vaccine candidate this summer and of its inactivated COVID-19 vaccine candidate by September 2021.
  • The AGMs voting results will be made available in the Investors & Media section of Valnevas corporate website in the coming days.
  • Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.
  • In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future.

Valneva Completes Recruitment for Phase 3 Lot-to-Lot Consistency Trial of its Chikungunya Vaccine Candidate

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星期四, 六月 10, 2021
Health sciences, Health, Medicine, Clinical trials, COVID-19 vaccines, Valneva SE, Clinical research, Design of experiments, Chikungunya

VLA1553 is the only chikungunya vaccine candidate in Phase 3 clinical trials at this time.

Key Points: 
  • VLA1553 is the only chikungunya vaccine candidate in Phase 3 clinical trials at this time.
  • Weve now enrolled all participants for both our pivotal Phase 3 trial and lot-to-lot consistency trial so our VLA1553 program is progressing extremely well.
  • The lot-to-lot consistency Phase 3 trial runs in parallel to the ongoing, pivotal Phase 3 trial, VLA1553-301, for which the Company already announced recruitment completion in April 20211.
  • In the Phase 1 clinical trial of VLA1553, Valneva observed development of antibodies to chikungunya virus resulting in 100% seroconversion of the 120 healthy participants.

Valneva Completes Phase 3 Trial Recruitment for its Inactivated COVID-19 Vaccine Candidate

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星期四, 六月 3, 2021
Clinical trials, COVID-19 vaccines, Vaccines, Drugs, Vaccination, VLA2001, Valneva SE, COVID-19 vaccine, Inactivated vaccine, COVID-19 vaccination in Norway, COVID-19 vaccination in Hungary

Over 4,000 volunteers in the United Kingdom have been randomized in the Phase 3 trial Cov-Compare (VLA2001-301), which compares Valnevas SARS-CoV-2 vaccine candidate, VLA2001, against AstraZenecas conditionally approved vaccine, Vaxzevria1.

Key Points: 
  • Over 4,000 volunteers in the United Kingdom have been randomized in the Phase 3 trial Cov-Compare (VLA2001-301), which compares Valnevas SARS-CoV-2 vaccine candidate, VLA2001, against AstraZenecas conditionally approved vaccine, Vaxzevria1.
  • Based on our Phase 1/2 clinical data and, assuming successful Phase 3 results, we believe that our inactivated vaccine can make a major contribution to the ongoing fight against the COVID-19 pandemic.
  • Valneva recently announced that it is participating in the worlds first COVID-19 vaccine booster trial in the UK2.
  • VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe.

Valneva Reports Q1 2021 Financial Results and Business Update

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星期四, 五月 20, 2021
Companies, Valneva SE, Pfizer, Vaccine, Medical specialties, Life sciences

b'Saint Herblain (France), May 20, 2021 \xe2\x80\x93 Valneva SE (\xe2\x80\x9cValneva\xe2\x80\x9d or \xe2\x80\x9cthe Company\xe2\x80\x9d), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, reported today its first quarter financial results ending March 31, 2021.

Key Points: 
  • b'Saint Herblain (France), May 20, 2021 \xe2\x80\x93 Valneva SE (\xe2\x80\x9cValneva\xe2\x80\x9d or \xe2\x80\x9cthe Company\xe2\x80\x9d), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, reported today its first quarter financial results ending March 31, 2021.
  • The condensed consolidated interim financial results are available on the Company\xe2\x80\x99s website www.valneva.com .\nValneva will provide a live webcast of its first quarter financial results conference call beginning at 3 p.m. CET today.
  • The dosing of the first trial participant in March 20215 triggered a milestone payment from Pfizer of $10 million that was received in the second quarter of 2021.
  • Interest charges increased to \xe2\x82\xac4.6\xc2\xa0million in the first quarter of 2021 compared to \xe2\x82\xac1.3\xc2\xa0million in the same period of 2020.

Valneva to Participate in the World’s First COVID-19 Vaccine Booster Trial in the UK

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星期三, 五月 19, 2021
Clinical trials, COVID-19 vaccines, Medicine, Health sciences, Health, VLA2001, Valneva SE, COVID-19 vaccine, Vaccine

One booster will be provided to each volunteer and could be a different brand to the one they were originally vaccinated with.

Key Points: 
  • One booster will be provided to each volunteer and could be a different brand to the one they were originally vaccinated with.
  • Valneva has the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe and we believe our VLA2001 vaccine has an important role to play in the ongoing pandemic, including as a booster.
  • This trial compares Valneva\xe2\x80\x99s SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca\xe2\x80\x99s conditionally approved vaccine, Vaxzevria2.
  • Recruitment for the trial, conducted in the U.K. and supported by the National Institute for Health Research (NIHR), is ongoing ( https://www.ukcovid19study.com/ ).

Citi Appointed as Depositary Bank for Valneva SE’s ADR Programme

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星期二, 五月 11, 2021
Biotechnology, Professional services, Health, Finance, Citigroup, Companies, Finance, Economy of New York City, Valneva SE, Depositary receipt, Citibank, American depositary receipt, Valneva, Citi, VALNEVA, CITI

b'Citi, acting through Citibank N.A., has been appointed by Valneva SE (\xe2\x80\x9cValneva\xe2\x80\x9d), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, to act as depositary bank for its American Depositary Receipt (\xe2\x80\x9cADR\xe2\x80\x9d) programme.\nValneva\xe2\x80\x99s American Depositary Shares (\xe2\x80\x9cADS\xe2\x80\x9d) trade on the Nasdaq Global Select Market under the symbol \xe2\x80\x9cVALN\xe2\x80\x9d.

Key Points: 
  • b'Citi, acting through Citibank N.A., has been appointed by Valneva SE (\xe2\x80\x9cValneva\xe2\x80\x9d), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, to act as depositary bank for its American Depositary Receipt (\xe2\x80\x9cADR\xe2\x80\x9d) programme.\nValneva\xe2\x80\x99s American Depositary Shares (\xe2\x80\x9cADS\xe2\x80\x9d) trade on the Nasdaq Global Select Market under the symbol \xe2\x80\x9cVALN\xe2\x80\x9d.
  • Each ADS represents two ordinary shares of the company.
  • The Company has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.\nCiti, the leading global bank, has approximately 200 million customer accounts and does business in more than 160 countries and jurisdictions.
  • Citi provides consumers, corporations, governments and institutions with a broad range of financial products and services, including consumer banking and credit, corporate and investment banking, securities brokerage, transaction services, and wealth management.\nAdditional information may be found at www.citigroup.com | Twitter: @Citi | YouTube: www.youtube.com/citi | Blog: http://blog.citigroup.com | Facebook: www.facebook.com/citi | LinkedIn: www.linkedin.com/company/citi\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210511005487/en/\n'

Valneva Announces Launch of Proposed Global Offering, Start of the Roadshow and Nasdaq Listing

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星期四, 四月 29, 2021
Financial markets, Stock market, Financial economics, Finance, U.S. Securities and Exchange Commission, Initial public offering, Prospectus, Registration statement, Security, ADSS, Valneva SE, Book building

The Company\xe2\x80\x99s ordinary shares are listed on the regulated market of Euronext in Paris (\xe2\x80\x9cEuronext\xe2\x80\x9d) under the symbol \xe2\x80\x9cVLA.\xe2\x80\x9d The Company has applied to list its ADSs on the Nasdaq Global Market under the ticker symbol \xe2\x80\x9cVALN.\xe2\x80\x9d\nGoldman Sachs, Jefferies, Guggenheim Securities and Bryan, Garnier & Co. are acting as joint bookrunners for the Global Offering.

Key Points: 
  • The Company\xe2\x80\x99s ordinary shares are listed on the regulated market of Euronext in Paris (\xe2\x80\x9cEuronext\xe2\x80\x9d) under the symbol \xe2\x80\x9cVLA.\xe2\x80\x9d The Company has applied to list its ADSs on the Nasdaq Global Market under the ticker symbol \xe2\x80\x9cVALN.\xe2\x80\x9d\nGoldman Sachs, Jefferies, Guggenheim Securities and Bryan, Garnier & Co. are acting as joint bookrunners for the Global Offering.
  • Namsen Capital is acting as Valneva\xe2\x80\x99s capital markets advisor.\nThe offering price per ADS in U.S. dollars and the corresponding offering price per ordinary share in euros, as well as the final number of ADSs and ordinary shares sold in the Global Offering, will be determined following a bookbuilding process commencing immediately.
  • These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective.\nThe securities referred to in this press release will be offered in the United States only by means of a prospectus (as part of a registration statement on Form F-1).
  • The Company has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.\n"

Valneva Initiates Phase 3 Clinical Trial for its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001

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星期三, 四月 21, 2021
COVID-19 vaccines, Clinical trials, Medical specialties, Medicine, Infectious diseases, Valneva SE, VLA2001, Encephalitis vaccine, Japanese encephalitis vaccine, Oxford–AstraZeneca COVID-19 vaccine, Japanese encephalitis

The trial is powered to demonstrate superiority of VLA2001 in terms of GMT ratio (VLA2001/Vaxzevria).

Key Points: 
  • The trial is powered to demonstrate superiority of VLA2001 in terms of GMT ratio (VLA2001/Vaxzevria).
  • As COVID-19 continues to impact people\xe2\x80\x99s daily lives, we remain fully focused on developing another safe and efficacious vaccine solution.
  • We believe that VLA2001 has an important role to play including boosters or potential modifications to the vaccine to address variants.
  • VLA2001 is produced on Valneva\xe2\x80\x99s established Vero-cell platform, leveraging the manufacturing technology for Valneva\xe2\x80\x99s licensed Japanese encephalitis vaccine, IXIARO\xc2\xae.

Valneva Switches Focus to Bilateral Discussions to Supply its Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001

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星期二, 四月 20, 2021
Vaccines, Drugs, Vaccination, Medical specialties, Clinical trials, COVID-19 vaccines, VLA2001, Valneva SE, Virology, Japanese encephalitis vaccine, Hepatitis B vaccine, Vaccine

Despite our recent clinical data, we have not made meaningful progress and have not yet secured a supply agreement.

Key Points: 
  • Despite our recent clinical data, we have not made meaningful progress and have not yet secured a supply agreement.
  • It has been declared a pandemic by the World Health Organization (WHO) .\nVLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe.
  • VLA2001 is produced on Valneva\xe2\x80\x99s established Vero-cell platform, leveraging the manufacturing technology for Valneva\xe2\x80\x99s licensed Japanese encephalitis vaccine, IXIARO\xc2\xae.
  • CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B\xc2\xae vaccine.