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 that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. It currently provides three proprietary travel vaccines: IXIARO, DUKORAL, and IXCHIQ. The IXIARO is an inactivated Vero cell culture-derived Japanese encephalitis vaccine indicated for active immunization against Japanese encephalitis in adults, adolescents, children, and infants aged two months and older. The DUKORAL is a drinkable vaccine that helps prevent diarrhea caused by heat-labile toxin-producing ETEC, as well as cholera. The IXCHIQ is a single-dose, live-attenuated vaccine for the prevention of disease caused by chikungunya virus. The company also offers additional vaccines, including VLA1553, VLA15, VLA160, VLA200, VLA1601 and others. Valneva was founded on May 28, 2013 and is headquartered in Saint-Herblain, France.

The stock price of Valneva SE (NASDAQ: VALN) increased by over 17% pre-market. This is why it happened.

Valneva SE (VALN) Stock: Why The Price Increased Today

Valneva SE (NASDAQ: VALN) has signed an Advance Purchase Agreement (APA) with the European Commission (EC) to supply up to 60 million doses of its inactivated COVID-19 vaccine candidate VLA2001, over two years.  The agreement follows the announcement made earlier this month that the EC had approved the APA.

Why Are Valneva Shares Trading Higher Today?

Saint- Herb lain (France ) , November 23 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has signed an Advance Purchase Agreement (APA) with the European Commission (EC) to supply up to 60 million doses of its inactivated COVID-19 vaccine candidate, VLA2001, over two years. The agreement follows the announcement made earlier this month that the EC had approved the APA1.

Valneva Signs Purchase Agreement with European Commission for its Inactivated COVID-19 Vaccine VLA2001

Valneva Reports Nine-Month 2021 Revenue and Cash

Saint - Herblain ( France), November 15 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced it will present its Chikungunya vaccine candidate, VLA1553, on November 18 and 19, 2021 during the American Society of Tropical Medicine & Hygiene (ASTMH) 2021 Annual Meeting.

Valneva to Present its Chikungunya Vaccine Candidate at the ASTMH 2021 Annual Meeting

Valneva (VALN) enters into a supply agreement for its COVID vaccine candidate with the European Commission. The stock price surges following the news.

Valneva (VALN) Stock Rises on Deal With EU for COVID-19 Jab

Saint- Herb lain (France ) , November 10 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Commission (“EC”) has approved an agreement pursuant to which Valneva would supply up to 60 million doses of VLA2001, its inactivated COVID-19 vaccine candidate, over two years including approximately 27 million doses in 2022.

Valneva Announces European Commission Approval of Advance Purchase Agreement for up to 60 Million Doses of Inactivated COVID-19 Vaccine VLA2001

Saint- Herblain (France), November 3 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (the “Company”), a specialty vaccine company, announced today the closing which occurred on November 2, 2021 of its previously announced global offering to specified categories of investors of an aggregate 5,175,000 new ordinary shares, after full exercise of the overallotment option granted to the underwriters (the “Option”), consisting of a public offering of 354,060 American Depositary Shares (“ADSs”), each representing two ordinary shares, in the United States at an offering price of $39.42 per ADS (the “U.S. Offering”), and a concurrent private placement of 4,466,880 ordinary shares in Europe (including France) and other countries outside of the United States at the corresponding offering price of €17.00 per ordinary share (the “European Private Placement”, and, together with the U.S. Offering, the “Global Offering”). Aggregate gross proceeds of the Global Offering, after full exercise of the Option and before deducting underwriting commissions and estimated expenses payable by the Company, were approximately $102.0 million (€88.0 million).

Valneva Announces Closing of Approximately $102.0 Million Global Offering

Saint-Herblain (France), October 29, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (the “Company”), a specialty vaccine company, announces trading resumption of its ordinary shares on the regulated market of Euronext in Paris as from 3:30 PM CET today.

Valneva announces trading resumption 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, 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

Revance Therapeutics

The Nasdaq looks poised to open slightly lower after a strong week.

These 2 Nasdaq Biotechs Are Making Huge Premarket Moves Monday

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.

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