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.

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Pfizer

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

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Dynavax Technologies

Saint- Herb lain (France ) , September 2 6 , 202 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced a further update on its COVID-19 vaccine activities.

Valneva Provides Further Update on its COVID-19 Activities

Saint- Herb lain (France ) and Dessau - Roßlau (Germany), September 16 , 202 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and IDT Biologika today announced they have agreed to terminate their collaboration following the delivery of inactivated COVID-19 bulk vaccine to Valneva, and considering the current order levels and existing inventories.

Valneva and IDT Biologika Agree on Termination of their COVID-19 Collaboration

VBI Vaccines

SAINT-HERBLAIN, France & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (Valneva) and VBI Vaccines Inc. (Nasdaq: VBIV) (VBI) today announced a partnership in select European markets for the marketing and distribution of PreHevbri® [Hepatitis B vaccine (recombinant, adsorbed)], the only 3-antigen hepatitis B vaccine approved in Europe. Under the terms of the agreement, specialty vaccine company Valneva will promote and distribute PreHevbri throughout select Eur

Valneva and VBI Vaccines Announce European Partnership for Marketing and Distribution of PreHevbri®

Saint- Herb lain (France ) , September 6 , 2 02 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that The Lancet Infectious Diseases (“The Lancet ID ”), a peer-reviewed medical journal, has published the Company's pivotal Phase 3 clinical data for its inactivated, whole-virus COVID-19 vaccine, VLA2001.

Valneva Announces Publication of its COVID-19 Vaccine Phase 3 Data in The Lancet Infectious Diseases

Saint- Herblain (France), August 29 , 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported further positive Phase 3 results for its inactivated, adjuvanted COVID-19 vaccine VLA2001. Additional readouts from the Company's pivotal VLA2001-301 “Cov-Compare” trial showed persistent immunogenicity and first positive heterologous booster results following primary vaccination with ChAdOx1-S (AstraZeneca).

Valneva Reports Further Positive Phase 3 Immunogenicity and the First Heterologous Booster Results for its Inactivated, Adjuvanted COVID-19 Vaccine VLA2001

Saint-Herb lain (France) , August 2 3 , 2 02 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, confirms today that the World Health Organization (WHO) has issued recommendations for use of the Company's inactivated COVID-19 vaccine.

Valneva Confirms WHO Recommendations for its Inactivated COVID-19 Vaccine

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

Valneva Initiates Rolling Submission of FDA Biologics License Application for its Single-Shot Chikungunya Vaccine Candidate

Saint Herblain ( France), August 18 , 202 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today announced that the U.S. Department of Defense (DoD) has decided not to exercise the second option year of the contract1 to supply Valneva's Japanese encephalitis (JE) vaccine IXIARO®.

Valneva Provides Update on IXIARO® Supply Contract with U.S. Department of Defense

Saint- Herb lain (France ) , August 15 , 2 02 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has filed a prospectus supplement with the U.S. Securities and Exchange Commission (“SEC”) relating to an At-the-Market offering (the “ATM Program”). Pursuant to this new financing program, the Company may offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $75.0 million of American Depositary Shares (“ADS”), each ADS representing two of the Company's ordinary shares, from time to time in sales deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, and pursuant to the terms of an Open Market Sale Agreement (the “Sales Agreement”) with Jefferies LLC (“Jefferies”), acting as sales agent, subject to French regulatory limits. The timing of any sales will depend on a variety of factors and the Company is not under any obligation to utilize the ATM Program in a specified amount or at all.

Valneva Establishes an At-the-Market (ATM) Program on Nasdaq

Vaccine developer Valneva on Thursday cut its full-year revenue outlook to account for lower orders of its COVID-19 vaccine after both the European Union and the UK walked away from supply contracts worth more than $1 billion combined.

Valneva cuts full-year outlook on lower COVID-19 vaccine sales

Excellent progress on late-stage clinical programs

Valneva Reports H1 2022 Results and Provides Corporate Updates

DUNCANSVILLE, Pa. — Researchers are seeking thousands of volunteers in the U.S. and Europe to test the first potential vaccine against Lyme disease in 20 years — in hopes of better fighting the tick-borne threat.

Pfizer, Valneva begin major test of first possible Lyme vaccine in 20 years

NEW YORK & SAINT-HERBLAIN, France--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced the initiation of a Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), to investigate the efficacy, safety and immunogenicity of their investigational Lyme disease vaccine candidate, VLA15. “With increasing global rates of Lyme disease, providing a new option for people to help protect themselves from the disea

Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15

Valneva is a specialty vaccines company with an ongoing travelers vaccine business. Two major catalysts are around the corner: a BLA for chikungunya vaccine and a Phase 3 trial for the world's only Lyme vaccine candidate.

Valneva: Vaccine Business, Catalysts Ahead, And Pfizer's Lyme Love

Saint- Herb lain (France ) , August 1 , 2 02 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today confirms the signing of the amendment to its Advance Purchase Agreement (APA)1 with the European Commission (EC), following expiration of the Member States' opt-out period, as announced by the Company on July 20, 20222. Under this amendment, the Member States' purchases of VLA2001, Valneva's inactivated whole-virus COVID-19 vaccine, consist of 1.25 million doses of VLA2001 in 2022, with the option to purchase an equivalent quantity later this year for delivery in 2022.

Valneva Confirms Amendment of Advance Purchase Agreement with European Commission for Valneva's Inactivated COVID-19 Vaccine

European Commission to order 1.25 million doses of Valneva's whole-virus COVID-19 vaccine VLA2001 in 2022

European Commission Approves Purchase Agreement Amendment for Valneva's Inactivated COVID-19 Vaccine

Valneva (NASDAQ: VALN) has had a good run this week. It soared 49% at the beginning of trading day Monday and has continued its positive ride.

This Biotech Company Is Soaring; Do Not Be Left Out.

VLA2001 becomes the first COVID-19 vaccine to receive a standard marketing authorization in Europe

Valneva Receives Marketing Authorization in Europe for Inactivated Whole-Virus COVID-19 Vaccine VLA2001

Saint - Herblain ( France), June 24 , 202 2 – Valneva S E (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Management Board were approved by the shareholders at its Annual General Meeting (AGM) held yesterday in Paris.

Valneva Announces Successful Outcome of its AGM and Appointment of two New Supervisory Board Members

Saint- Herblain (France) and New York, June 2 3 , 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE) today announced the closing of the equity investment announced on June 20, 2022.1

Valneva and Pfizer Announce Closing of Equity Investment

Saint - Herblain ( France), June 2 3 , 202 2 – Valneva S E (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces the resumption of trading of its ordinary shares on the regulated market of Euronext in Paris, starting at 4:30pm CEST today.

Valneva announces resumption of trading of its ordinary shares on Euronext Paris

Saint Herblain (France ), June 23 , 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization in Europe for Valneva's inactivated whole-virus COVID-19 vaccine candidate, VLA2001, for use as primary vaccination in people from 18 to 50 years of age.

Valneva Receives Positive CHMP Opinion for Marketing Authorization of its Inactivated COVID-19 Vaccine Candidate in Europe

Valneva SE Sponsored ADR (VALN) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions may not translate into further price increase in the near term.

News for Valneva SE Stock (VALN)