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.

Pfizer

Valneva SE VALN and Pfizer Inc PFE have reported further Phase 2 data for their Lyme disease vaccine candidate, VLA15.  Get the Inside Access Traders Are Using to Profit More and Win Bigger.

Valneva - Pfizer Choose Three-Dose Schedule For Lyme Vaccine Candidate Moving Forward

Saint-Herblain (France) and New York, February 4, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE) today reported further positive Phase 2 data for their Lyme disease vaccine candidate, VLA15. Based on these new results, Valneva and Pfizer plan to proceed with a three-dose primary series vaccination schedule in a planned Phase 3 clinical trial. The trial will evaluate VLA15 in adults and pediatric subjects 5 years of age and above and is expected to be initiated in 2022, subject to regulatory approval.

Valneva and Pfizer Report Further Positive Phase 2 Data for Lyme Disease Vaccine Candidate

Total revenues of €348.1 million in 2021 compared to €110.3 million in 2020 – an increase of 216%

Valneva Reports Full Year 2021 Revenue and Cash; Provides First 2022 Guidance

CEPI-funded trial intended to support potential label expansion in this age group

Valneva Announces Initiation of Adolescent Phase 3 Trial for its Single-Shot Chikungunya Vaccine Candidate

Valneva SE (NASDAQ: VALN) has started booster vaccinations in adult participants from its Phase 3 pivotal trial, Cov-Compare.  This booster extension is intended to provide both homologous and first heterologous booster data to complement previous positive Phase 1/2 booster results.

Valneva Advances Booster Phase Of Its Cov-Compare COVID-19 Vaccine Trial

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Three doses of Valneva's (VALN) inactivated COVID-19 vaccine candidate, VLA2001, neutralizes the Omicron variant of SARS-CoV-2, per data from preliminary lab studies. Shares rally.

Valneva (VALN) Up as COVID-19 Jab Neutralizes Omicron Variant

Valneva is picking up attention as the biotech firm is up more than 30% today. Will its vaccine candidate power VALN stock to new highs?

VALN Stock Alert: 4 Things to Know About the Vaccine News Sending Valneva Soaring

Valneva SE (NASDAQ: VALN) is trading significantly higher Wednesday following results from an initial laboratory study, which demonstrated that serum antibodies induced by three doses of Valneva's COVID-19 vaccine candidate, VLA2001, neutralize the omicron variant. Samples from 30 participants in the Phase 1/2 trial of Valneva's COVID-19 candidate were used in a pseudovirus assay to analyze neutralization of the ancestral SARS-CoV-2 virus as well as the delta and omicron variants.

Why Valneva Shares Are Soaring Today

Saint Herblain (France), January 19 , 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced results from an initial laboratory study demonstrating that serum antibodies induced by three doses of Valneva's inactivated COVID-19 vaccine candidate, VLA2001, neutralize the Omicron variant.

Valneva's Inactivated COVID-19 Vaccine Candidate Shown to Neutralize Omicron Variant

Saint Herblain (France), January 6 , 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today confirms the previously communicated timelines of its clinical trials and regulatory submissions for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

Valneva Confirms Clinical Trial and Regulatory Submission Timelines for its Inactivated COVID-19 Vaccine Candidate VLA2001

Shares in biotech company Valneva fell again on Wednesday, declining for the seventh day in a row due to a growing belief amongst investors that the COVID-19 Omicron variant might lessen the need for mass vaccination.

Shares in COVID-19 vaccine developer Valneva extend fall

Saint Herblain ( France), December 23 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it is in advanced discussions, with Scottish Enterprise, for a multi-million pound grant which will enable it to fully complete its strategic manufacturing site in Livingston, Scotland.

Valneva and Scottish Enterprise in Advanced Discussions for Major Grant to Complete Livingston Site

Saint Herblain ( France), December 21 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive topline results from the lot-to-lot Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553. The VLA1553-302 trial met its primary endpoint, demonstrating that three consecutively manufactured vaccine lots elicited equivalent immune responses measured by neutralizing antibody titer GMT ratios on Day 29 after vaccination.

Valneva Announces Positive Lot-to-Lot Consistency Trial Results for its Single-Shot Chikungunya Vaccine Candidate

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U.S.-listed shares of Valneva SE VALN, +12.95% were up 14.9% in trading on Thursday after the company said in a news release that its experimental COVID-19 booster shot boosted antibody levels in people who were already vaccinated with Valneva's primary series of shots. The Phase 1/2 study assessed antibody levels between seven to eight months after participants had been fully vaccinated with the company's shots, which are still considered investigational.

Valneva's stock is up 14% after the company shares promising data for its COVID-19 booster candidate

Saint Herblain ( France), December 16 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive homologous booster data from the Phase 1/2 study, of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Initial results confirm that VLA2001 significantly boosted immunity in participants who received VLA2001 as a primary vaccination.

Valneva Announces Positive Homologous Booster Data for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001

Saint-Herb lain (France ) , December 8 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the signing of an advance purchase agreement with the Kingdom of Bahrain for the supply of one million doses of the Company's inactivated COVID-19 vaccine candidate VLA2001. This is the second purchase agreement Valneva has secured for VLA2001 since reporting positive data for its Phase 3 clinical trial Cov-Compare.

Valneva Signs Advance Purchase Agreement with Bahrain for Inactivated COVID-19 Vaccine VLA2001

Valneva SE (NASDAQ: VALN) has responded to data published from the U.K COV-Boost COVID-19 vaccine trial that investigated the reactogenicity and immunogenicity of seven different COVID-19 vaccines at different dose levels in vaccinated individuals. All seven vaccines given in the COV-Boost study increased immunity when given as booster shots to people who had previously received two doses of AstraZeneca Plc's (NASDAQ: AZN) Vaxzevria.

Valneva's COVID-19 Shot Fails As Booster In Pfizer/BioNTech Vaccinated Population

Saint Herblain ( France), December 3 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today responded to data published from the COV-Boost COVID-19 vaccine trial, which investigated the reactogenicity and immunogenicity of seven different COVID-19 vaccines at different dose levels when administered as a third dose, or booster, to people primed with either Pfizer's Comirnaty or AstraZeneca's Vaxzevria.

Valneva Comments on COV-Boost Clinical Trial Data

Saint- Herb lain (France ) , December 2 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today confirmed that the European Medicines Agency (EMA) has started a rolling review of VLA2001, its whole-virus inactivated, adjuvanted COVID-19 vaccine candidate.

Valneva Confirms Initiation of Rolling Review with EMA and Provides Updates on its COVID-19 Vaccine Program VLA2001

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Valneva SE (NASDAQ: VALN) and IDT Biologika have announced their collaboration to produce Valneva's inactivated COVID-19 vaccine candidate VLA2001.  It follows last week's announcement that Valneva signed an Advance Purchase Agreement with the European Commission to supply up to 60 million doses of VLA2001 over two years.

Valneva Recruits IDT Biologika As Manufacturing Partner For Its COVID-19 Vaccine

Saint- Herb lain (France ) and Dessau - Roßlau (Germany), November 29 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and IDT Biologika today announced their collaboration for the production of Valneva's inactivated COVID-19 vaccine candidate VLA2001. This follows last week's announcement that Valneva signed an Advance Purchase Agreement with the European Commission to supply up to 60 million doses of VLA2001, over two years.

News for Valneva SE Stock (VALN)