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

Earnings data Q2 2021

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.

Valneva SE is a French biotechnology company specializing in developing and commercializing vaccines. We expect approval of two attractive vaccine candidates targeting Chikungunya and Lyme disease by 2024-2025.

Valneva SE: Underfollowed French Biotech, 2 Interesting Vaccine Approvals Expected In 2023

Saint - Herblain ( France), February 20 , 2 02 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Administration (FDA) has completed a filing review of its Biologics License Application for Valneva's single-shot chikungunya vaccine candidate VLA1553 and has determined that the application is sufficiently complete to permit a substantive review. The review classification is Priority.

FDA Accepts Valneva's Chikungunya Vaccine License Application for Priority Review

Valneva stock plummeted Friday after Pfizer said it will drop roughly half of the participants enrolled in their Lyme disease vaccine study. The post Valneva Shares Topple As It Hits Ethics Roadblock With Pfizer In Lyme Disease Test appeared first on Investor's Business Daily.

Valneva Shares Topple As It Hits Ethics Roadblock With Pfizer In Lyme Disease Test

Pfizer

New York & Saint- Herblain (France), February 17, 2023 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announce that Pfizer, as the study sponsor, has decided to discontinue a significant percentage of participants in the U.S. who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. The study is investigating the efficacy, safety and immunogenicity of an investigational Lyme disease vaccine candidate, VLA15. These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator. The discontinuation of these participants was not due to any safety concerns with the investigational vaccine and was not prompted by a participant-reported adverse event.

Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

Total revenue s of €3 6 1 . 3 million in 202 2 were ahead of previously communicated guidance of €340 million to €360 million 1 (compared to €348 . 1 million in 2021)

Valneva Reports Full Year 2022 Revenue and Cash, Provides First 2023 Guidance

Saint - Herblain ( France), February 14 , 2 02 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it completed enrollment and vaccination for a Phase 3 trial in adolescents, VLA1553-321, of its single-shot chikungunya vaccine candidate, VLA1553. First results of the trial are expected mid-2023.

Valneva Completes Enrollment for Adolescent Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate

Valneva's (VALN) COVID-19 vaccine looks promising, but the European Commission's revised advance purchase agreement jeopardizes its COVID-19 vaccine program.

Valneva (VALN) Stock Down 61.5% in the Past Year: Here's Why

Valneva SE Sponsored ADR (VALN) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

What Makes Valneva SE Sponsored ADR (VALN) a New Buy Stock

Dynavax Technologies

Saint- Herb lain (France ) , December 30 , 202 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported further heterologous booster data from an exploratory, small clinical study for its inactivated COVID-19 vaccine, VLA2001.

Valneva Reports Further Heterologous Booster Data for its inactivated COVID-19 vaccine

Saint- Herb lain (France ) , December 23 , 2 02 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that it has completed rolling submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its single-shot chikungunya vaccine candidate, VLA1553. Valneva is seeking approval of its investigational chikungunya vaccine in persons aged 18 years and above.

Valneva Completes BLA Submission to U.S. FDA for its Single-Shot Chikungunya Vaccine Candidate

Valneva (VALN) posts encouraging 12-month antibody persistence data for its single-shot chikungunya vaccine candidate, VLA1553. Shares rise.

Valneva (VALN) Up on Antibody Persistence Data on Chikungunya Jab

Saint - Herblain ( France), December 5 , 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive antibody persistence data twelve months after vaccination with a single dose of its chikungunya vaccine candidate, VLA1553.

Valneva Reports Positive 12-Month Antibody Persistence Data for Single-Shot Chikungunya Vaccine Candidate

Persistence data from a mid-stage study showed that Valneva's (VALN) Lyme disease vaccine elicited antibody levels which remained above baseline six months after completing dose administration in children and adults.

Valneva (VALN) Up on 6-Month Lyme Disease Jab Persistence Data

Valneva stock rose Thursday after it said volunteers who received its Pfizer-partnered Lyme disease shot still had antibodies after six months. The post Will A Pfizer-Partnered Vaccine Help Valneva Stock Buck Its Recent Downtrend?

Will A Pfizer-Partnered Vaccine Help Valneva Stock Buck Its Recent Downtrend?

New York & Saint- Herblain (France) , December 1 , 2022 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today reported antibody persistence data six months after the completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule with their Lyme disease vaccine candidate, VLA15 in both children and adults. This is the first time antibody persistence data are reported in pediatric populations for this vaccine candidate.

Valneva and Pfizer Report Six-Month Antibody Persistence Data in Children and Adults for Lyme Disease Vaccine Candidate

Live event and webcast December 6, 2022 10 AM – 12 PM ET

Valneva to Host Investor Day in New York City

Saint- Herblain (France), November 1 7 , 202 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the appointment of Dipal Patel as Chief Commercial Officer (CCO) and Management Board member. With this newly created role, Valneva strengthens its management team with a recognized commercial industry leader as the Company advances its chikungunya vaccine candidate towards potential market entry in 2023.

Valneva Appoints Dipal Patel as Chief Commercial Officer

The mean of analysts' price targets for Valneva SE Sponsored ADR (VALN) points to a 65.1% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Wall Street Analysts See a 65% Upside in Valneva SE Sponsored ADR (VALN): Can the Stock Really Move This High?

Valneva SE (NASDAQ:VALN ) Q3 2022 Earnings Conference Call November 10, 2022 9:00 AM ET Company Participants Thomas Lingelbach – President and Chief Executive Officer Peter Buhler – Chief Financial Officer Conference Call Participants Maury Raycroft – Jefferies Samir Devani – Rx Securities Evan Wang – Guggenheim Partners Max Herrmann – Stifel Arsene Guekam – Kepler Cheuvreux Olga Smolentseva – Bryan Garnier Nick Hallatt – Goldman Sachs Operator Good day, and thank you for standing by. Welcome to the Valneva Reports Nine-Month 2022 Results and Provides Corporate Updates Call.

Valneva SE (VALN) Q3 2022 Earnings Call Transcript

Total n ine-month revenue s of €249.9 million , a ~ 3.5-fold increase compared to 2021

Valneva Reports Nine-Month 2022 Results and Provides Corporate Updates

Valneva SE Sponsored ADR (VALN) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

All You Need to Know About Valneva SE Sponsored ADR (VALN) Rating Upgrade to Buy

Saint- Herb lain (France ) , October 10 , 2 02 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today it will present on its single-shot chikungunya vaccine candidate at several leading scientific conferences during the fourth quarter of 2022.

Valneva to Present on its Single-Shot Chikungunya Vaccine Candidate at Leading Scientific Conferences

Saint Herblain (France), October 4, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (the “Company”), a specialty vaccine company, announced today the closing of its previously announced global offering to specified categories of investors of an aggregate 21,000,000 new ordinary shares, consisting of a public offering of 375,000 American Depositary Shares (“ADSs”), each representing two ordinary shares, in the United States at an offering price of $9.51 per ADS (the “U.S. Offering”), and a concurrent private placement of 20,250,000 ordinary shares in Europe (including France) and other countries outside of the United States at the corresponding offering price of €4.90 per ordinary share (the “European Private Placement”, and, together with the U.S. Offering, the “Global Offering”). Aggregate gross proceeds of the Global Offering, before deducting underwriting commissions and estimated expenses payable by the Company, were approximately €102.9 million ($99.9 million).

Valneva Announces Closing of Upsized €102.9 Million Global Offering

Saint Herblain (France), September 30, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (the “Company”), a specialty vaccine company, announced today the pricing of 21,000,000 ordinary shares in a global offering to specified categories of investors comprised of a public offering of 375,000 American Depositary Shares (“ADSs”), each representing two ordinary shares, in the United States (the “U.S. Offering”) and a concurrent private placement of 20,250,000 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 Pricing of €102.9 Million Global Offering of American Depositary Shares and Ordinary Shares

Saint Herblain (France), September 28, 2022 – 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, approximately $40 million 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”).

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