Valneva SE

Valneva SE is a specialty vaccine company. The firm focuses on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. It takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. It operates through the following segments: Commercialized products, COVID, Vaccine candidates and Technologies and services. The Commercialized products segment markets vaccines, currently IXIARO and DUKORAL vaccines, as well as third-party products. The COVID segment engages in the development, manufacturing and distribution related to COVID-19 vaccine candidate, VLA2001. The Vaccine candidates segment engages in proprietary research and development programs aiming to generate new approvable products in order to generate future cash flows from product sales or from commercialization through partnering with pharmaceutical companies, excluding COVID-19 vaccine candidate, VLA2001. The Technologies and services segment provides services and inventions at a commercialization stage. The company was founded on April 7, 1999 and is headquartered in Saint-Herblain, France.

Earnings data Q1 2021

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Earnings data Q4 2021

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Valneva SE is a specialty vaccine company, which focuses on the development, manufacturing, and commercialization of prophylactic vaccines for infectious diseases. It operates through the following segments: Commercialized Products, COVID, Vaccine Candidates, and Technologies and Services. The Commercialized Products segment markets vaccines, currently IXIARO and DUKORAL vaccines, as well as third-party products. The COVID segment develops, manufactures, and distribute related to COVID-19 vaccine candidate, VLA2001. The Vaccine Candidates segment focuses on proprietary research and development programs aiming to generate new approvable products to generate future cash flows from product sales or from commercialization through partnering with pharmaceutical companies. The Technologies and Services segment offers services and inventions at a commercialization stage. The company was founded on April 7, 1999 and is headquartered in Saint-Herblain, France.

Saint- Herblain (France), October 29 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (the “Company”), a specialty vaccine company, announces that trading of its ordinary shares on the regulated market of Euronext in Paris (“Euronext Paris”) will be suspended, at the Company's request, from the opening of the market at 9:00 AM CET.

Valneva announces temporary trading suspension of its ordinary shares on Euronext Paris

Saint- Herblain (France), October 29 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (the “Company”), a specialty vaccine company, announced today the pricing of 4,500,000 ordinary shares in a global offering to specified categories of investors comprised of a public offering of 16,560 American Depositary Shares (“ADSs”), each representing two ordinary shares, in the United States (the “U.S. Offering”), and a concurrent private placement of 4,466,880 ordinary shares in certain jurisdictions outside of the United States (the “European Private Placement”, and, together with the U.S. Offering, the “Global Offering”). The Company granted the underwriters an option to purchase (the “Option”) for a 30-day period up to 337,500 additional ADSs, each representing two ordinary shares. The aggregate gross proceeds are expected to be approximately $88.7 million, equivalent to approximately €76.5 million, before deducting underwriting commissions and estimated expenses payable by the Company.

Valneva Announces the Pricing of its Global Offering of American Depositary Shares and Ordinary Shares

Saint Herblain ( France), October 2 7 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the publication of an amendment filed with the French Financial Markets Authority (“AMF”) on October 26, 2021 under the filing number D.21-0286-A01 (the “URD Amendment”) to its 2020 Universal Registration Document (“URD”), filed with the AMF on April 9, 2021 under the filing number D.21-0286. The key amendments made to the URD, including certain information updates, are discussed below.

Valneva Publishes Amendment to 2020 Universal Registration Document

Saint Herblain ( France), October 2 6 , 202 1 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (the “Company”), a specialty vaccine company, today announced its intention to issue and sell, subject to market conditions, 5,500,000 of its ordinary shares in a global offering to specified categories of investors comprised of (i) a public offering of its American Depositary Shares (“ADSs”), each representing two ordinary shares, in the United States (the “U.S. Offering”) and (ii) a concurrent private placement of its ordinary shares in certain jurisdictions outside of the United States (the “European Private Placement” and together with the U.S. Offering, the “Global Offering”).

Valneva Announces Launch of Proposed Global Offering of American Depository Shares and Ordinary Shares

Valneva's (VALN) shares surge after its COVID vaccine demonstrates superiority over AstraZeneca's COVID vaccine in a phase III study.

Valneva (VALN) Reports Positive Data From COVID Vaccine Study

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Valneva SE's (NASDAQ: VALN) COVID-19 vaccine elicits a robust immune response with far fewer side effects than the Oxford/AstraZeneca plc's (NASDAQ: AZN) jab, according to Phase 3 trial results. Valneva said its latest trial, Cov-Compare, included around 4,000 participants aged 18 and older across 26 trial sites.

Why Are Valneva's Shares Trading Higher Monday Premarket?

Valneva's wild stock-price rise continued on Monday after the French biotech said its coronavirus vaccine candidate outperformed AstraZeneca's in a trial.

Europe Markets: Valneva shares spike after saying vaccine candidate outperformed AstraZeneca's

Saint Herblain ( France), October 18 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive topline results from the Phase 3 pivotal trial Cov-Compare of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Valneva's Chief Executive Officer, Thomas Lingelbach, and the trial's Chief Investigator, Adam Finn, Professor of Paediatrics at the University of Bristol, will comment on the results in a live webcast beginning at 3 p.m. CET today. Please refer to this link: https://edge.media-server.com/mmc/p/3zmb7nnp.

Valneva Reports Positive Phase 3 Results for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001

Saint- Herb lain (France) , October 4 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Management Board has decided, during a meeting today, to cancel all ordinary shares held by the Company following the termination of its liquidity agreement with Oddo BHF on June 11, 2021 (i.e., 4,025 ordinary shares in total, representing 0.004% of the share capital).

Valneva Announces the Cancellation of Ordinary Shares Held by the Company following Termination of its Liquidity Agreement

Saint- Herb lain (France) , September 30 , 2 021 – 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 Guggenheim Vaccines and Infectious Disease Conference on October 6, 2021.

Valneva to Present and Hold Investor Meetings at the Guggenheim Vaccines and Infectious Disease Conference

Pfizer

Valneva SE (NASDAQ: VALN) and Pfizer Inc (NYSE: PFE) have announced more positive Phase 2 results, including the booster response, for their Lyme disease vaccine candidate VLA15. The 246-subject study is evaluating the immunogenicity and safety of VLA15 in a Month 0-2-6 vaccination schedule.

Valneva, Pfizer Lyme Disease Vaccine Candidate Drops-Off After 18 Months

Valneva, Pfizer's Phase 2 Data Suggests Booster Strategy For Lyme Disease Vaccine Candidate

Saint- Herblain ( France) and New York (United States) , September 28 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE), today announced further positive Phase 2 results, including booster response, for Lyme disease vaccine candidate VLA15.

Valneva and Pfizer Report Further Positive Phase 2 Results, Including Booster Response, for Lyme Disease Vaccine Candidate

Valneva SE (NASDAQ: VALN) has commenced recruitment of adolescents in its pivotal Phase 3 trial for its inactivated COVID-19 vaccine candidate VLA2001 in the U.K. Topline results from the trial, dubbed Cov-Compare, are expected early in Q4 of 2021 and are intended to form the basis for potential regulatory approval in adults.

Valneva Continues To Expand COVID-19 Vaccine Candidate Trials

Saint- Herb lain (France ) , September 23 , 2021 – Valneva SE, (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today announced that it has commenced recruitment of adolescents in its pivotal Phase 3 Clinical Trial (VLA2001-301, “Cov-Compare”) for its inactivated COVID-19 vaccine candidate VLA2001 in the United Kingdom. Topline results from the pivotal Cov-Compare trial are expected early in the fourth quarter of 2021 and are intended to form the basis for potential regulatory approval in adults. The Company has also started to provide boosters to volunteers in its Phase 1/2 VLA2001-201 trial. This planned expansion of VLA2001 clinical trials will support future approval in further age groups, in addition to adults.

Valneva Continues Expansion of Clinical Trials of its Inactivated COVID-19 Vaccine Candidate VLA2001

New York, New York--(Newsfile Corp. - September 21, 2021) - Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ: VALN). Such investors are advised to contact Robert S. Willoughby at newaction@pomlaw.com or 888-476-6529, ext. 7980.The investigation concerns whether Valneva and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about...

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN

Government serves notice to terminate contract over allegations of a ‘breach of obligations'

UK cancels Covid vaccine deal with French firm Valneva

The stock price of Valneva SE (NASDAQ: VALN) fell by over 35% pre-market today. This is why it happened.

VALN Stock: Why It Significantly Decreased Today

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The stock price of Valneva SE (NASDAQ: VALN) increased by over 12% pre-market. This is why it happened.

VALN Stock: Over 12% Increase Pre-Market Explanation

Saint Herblain ( France), September 3 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today announced that the U.S. Department of Defense (DoD) has exercised the first option of the contract signed in September 20201 to purchase further supply of its Japanese encephalitis (JE) vaccine IXIARO®.

Valneva: U.S. DoD Exercises First Year Option on IXIARO® Supply Contract

Saint- Herb lain (France) , September 1 , 2 021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will participate in 1-on-1 meetings with institutional investors at the Goldman Sachs Eleventh Annual Biotech Symposium on September 7, 2021.

Valneva to Participate in Goldman Sachs Eleventh Annual Biotech Symposium

Valneva (VALN) starts rolling submission for the initial approval of its COVID-19 vaccine candidate, VLA2001, in the United Kingdom.

Valneva (VALN) Begins Submission for COVID-19 Vaccine in UK

Saint-Herblain (France), August 23, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on prophylactic vaccines for infectious diseases, today commenced rolling submission, for initial approval of its COVID-19 vaccine candidate, VLA2001, with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK). VLA2001 is a whole virus, inactivated, adjuvanted vaccine candidate and is the only vaccine candidate of this type currently in clinical trials in Europe.

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