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.

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.

Valneva Commences Rolling Submission to MHRA for its Inactivated, Adjuvanted COVID-19 Vaccine

Saint-Herblain (France), August 11th, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced the initiation of a further Phase 3 trial (VLA2001-304) for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

Valneva Initiates Further Phase 3 Clinical Trial for its COVID-19 Vaccine Candidate

Valneva Reports H1 2021 Financial Results and Provides Business Update

Saint Herblain ( France), August 5 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced positive topline results from the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553. VLA1553 was recently awarded Breakthrough Designation status by the Food and Drug Administration (FDA).

Valneva Announces Positive Phase 3 Pivotal Results for its Single-Shot Chikungunya Vaccine Candidate

Saint- Herblain (France), July 29 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced the appointment of Peter Buhler as Chief Financial Officer (CFO) and Management Board member.

Valneva Appoints Peter Buhler as Chief Financial Officer

Pfizer

Saint- Herblain ( France) and New York, NY , July 19 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, and Pfizer Inc. (NYSE: PFE), today announced that they have completed recruitment for the Phase 2 trial, VLA15-221, of Lyme disease vaccine candidate, VLA15. The trial builds on previous positive Phase 2 trials and includes both adult and pediatric participants with the aim to support acceleration of the vaccine candidate's pediatric program.

Valneva and Pfizer Complete Recruitment for Phase 2 Trial of Lyme Disease Vaccine Candidate

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The FDA grants Breakthrough Therapy Designation to Valneva SE's (NASDAQ: VALN) single-shot chikungunya vaccine candidate, VLA1553. This new U.S. milestone comes in addition to the FDA Fast Track designation and the European Medicines Agency's PRIME designation, which the Company received in December 2018 and in October 2020, respectively.

Valneva's Chikungunya Vaccine Candidate Gets FDA Breakthrough Tag

Saint- Herblain (France), July 6 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, announced today it has appointed Vincent Dequenne as Senior Vice President Operations and Joshua Drumm as Vice President Investor Relations.

Valneva Strengthens Management Team; Appoints Vincent Dequenne as SVP Operations and Joshua Drumm as VP Investor Relations

Saint Herblain ( France), July 5 , 2021 –Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, announced today it will host a virtual symposium titled, “Developing new vaccines to protect against infectious diseases at home and abroad” on July 9, 2021 at 14:15 CEST at the 31st European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).

Valneva to Host Symposium on COVID-19 and Chikungunya Vaccine Candidates at 31st European Congress of Clinical Microbiology & Infectious Diseases

Saint- Herblain (France), July 1 , 2021 – Following a media article published yesterday, Valneva SE, (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, indicated today it continues ongoing discussions with the European Commission regarding VLA2001, Valneva's inactivated COVID-19 vaccine candidate.

Valneva Continues Ongoing Discussions with the European Commission for Inactivated COVID-19 Vaccine Candidate

Saint - Herblain ( France), June 23 , 2021 – Valneva S E (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, announced today that all the resolutions recommended by the Management Board were approved by the shareholders at its Annual General Meeting (AGM) held as a closed session at its registered office on June 23, 2021.

Valneva Announces Successful Outcome of its AGM

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