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, which focuses on the development, manufacturing, and commercialization of prophylactic vaccines for infectious 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 develops, manufactures, and distribute related to COVID-19 vaccine candidate, VLA2001. The Vaccine Candidates segment focuses on proprietary research and development programs aiming to generate new approvable products to generate future cash flows from product sales or from commercialization through partnering with pharmaceutical companies. The Technologies and Services segment offers services and inventions at a commercialization stage. The company was founded on April 7, 1999 and is headquartered in Saint-Herblain, France.

Pfizer

SAINT-HERBLAIN, France & NEW YORK--(BUSINESS WIRE)--Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE) today announced that they have entered into an Equity Subscription Agreement and have updated the terms of their Collaboration and License Agreement for Lyme disease vaccine candidate VLA15. As previously announced on April 26, 2022, Pfizer plans to initiate the Phase 3 study of VLA15 in the third quarter of 2022. As part of the Equity Subs

Valneva and Pfizer Enter into an Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15

Though Valneva's (VALN) COVID-19 vaccine looks promising, the European Commission's intent to terminate the advance purchase agreement for the vaccine puts the future of the company's COVID-19 vaccine program into jeopardy.

Valneva (VALN) Stock Declines 59% in 3 Months: Here's Why

Dynavax Technologies

Saint- Herb lain (France ) , June 15 , 202 2 – Valneva SE, (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has entered into a settlement agreement with the Government of the United Kingdom (“HMG”) in relation to the termination of the supply agreement for Valneva's COVID-19 vaccine candidate, VLA2001.

Valneva Announces Settlement Agreement with the UK Government

Valneva (VALN) slides on a proposed remediation plan update after receiving the European Commission's notice of intent to terminate the Advance Purchase Agreement for its COVID-19 vaccine.

Valneva (VALN) Down on its COVID-19 Vaccine Update in Europe

Shares of Valneva SE VALN, -14.89% fell 13.3% in premarket trading on Monday after the company said it proposed a remediation plan to the European Commission after learning of plans to terminate the purchase agreement for Valneva's COVID-19 vaccine candidate. If the agreement reduces the total amount of vaccine in the order, that will impact the sustainability of the company's vaccine program, the company said.

Valneva's stock slides after saying Europe may not order the company's COVID-19 vaccine candidate

Valneva SE (NASDAQ: VALN) proposed a remediation plan after receiving the European Commission's notice of intent to terminate the advance purchase agreement for its inactivated COVID-19 vaccine candidate. "Some member states have confirmed their interest in having an.

Valneva Says Working On Remediation Plan For Investigational COVID-19 Vaccine

Saint-Herb lain (France ) , June 1 0 , 2 02 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today provides an update on its European inactivated whole-virus COVID-19 vaccine candidate VLA2001. Following receipt of the European Commission (EC)'s notice of intent to terminate the Advance Purchase Agreement (APA)1, Valneva proposed a remediation plan, which is now subject to further discussion within the EC and among the participating member states.

Valneva Provides Update on European Inactivated, Whole-Virus COVID-19 Vaccine Program VLA2001

Saint Herblain ( France), June 8 , 202 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced its inclusion in the Euronext Tech Leaders Index which was launched yesterday by Euronext.

Valneva Joins Euronext's Tech Leaders Index

Saint - Herblain ( France), June 7 , 20 22 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today it will present on its single-shot chikungunya vaccine candidate VLA1553 on June 9, 2022 at the 8th Northern European Conference on Travel Medicine (NECTM8) in Rotterdam.

Valneva to Present on its Single-Shot Chikungunya Vaccine Candidate, Host Symposium at NECTM8

Saint- Herb lain (France) , June 3 , 2 02 2 – 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 Jefferies Healthcare Conference which will take place from June 8 to 10, 2022 in New York.

Valneva to Present and Hold Investor Meetings at the Jefferies US Healthcare Conference

Saint Herblain ( France), June 2 , 202 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the availability of documentation for its Combined General Meeting and Special Meeting of holders of Convertible Preferred Shares.

Valneva Announces the Availability of Documentation for its Shareholder Meetings

Saint-Herblain (France), May 31, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today the appointment of leading vaccine experts Dr. Thomas Decker and Dr. Michael Pfleiderer to its Scientific Advisory Board (SAB).

Valneva Appoints Dr. Thomas Decker and Dr. Michael Pfleiderer to its Scientific Advisory Board

Saint Herblain ( France), May 25 , 202 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the successful completion of the lot-to-lot Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553. The final analysis included six-month follow-up data and confirmed the topline results reported in December 2021.

Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate

U.S.-listed shares of Valneva SE VALN, -3.09% VLA, +10.48% jumped 11.5% in premarket trading on Thursday after the company said that the European Medicines Agency has accepted the application of its COVID-19 vaccine candidate. If the experimental shot receives a positive recommendation from the EMA's Committee for Human Medicinal Products, the company said it expects a decision in June.

Valneva says the European Medicines Agency accepted application for its COVID-19 vaccine

Saint Herblain (France), May 1 9 , 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today confirmed that the European Medicines Agency (“EMA”) has accepted the filing of a marketing authorization application (MAA) for Valneva's inactivated, whole-virus COVID-19 vaccine candidate, VLA2001. Acceptance of the MAA means VLA2001 is advancing from the rolling review process and beginning the formal review process by the EMA's Committee for Human Medicinal Products (CHMP). If the CHMP accepts Valneva's conditional marketing authorization application, the Company confirms it would expect to receive a positive CHMP opinion in June 2022.

EMA Accepts Filing of Marketing Authorization Application for Valneva's Inactivated COVID-19 Vaccine Candidate

Per the agreement with the European Commission, Valneva (VALN) has 30 days from May 13, 2022 to win a marketing authorization in the EU for its COVID vaccine or offer an acceptable remediation plan.

Valneva (VALN) Down as EU Considers Ending COVID-Vaccine Deal

The European Commission said that no final decision had been made about the possible termination of a contract with Valneva SE (NASDAQ: VALN) to supply its COVID-19 vaccine to the European Union. Earlier today, Valneva said it received a notice of intent from the Commission to.

EU Says Final Decision Yet To Be Taken On Terminating Valneva COVID-19 Vaccine Deal

(Reuters) -Valneva lost nearly a fifth of its value on Monday after the French drugmaker said its COVID-19 vaccine agreement with the European Commission was likely to be scrapped and it might have to rethink its financial guidance.

Valneva shares slump after COVID vaccine deal with EU falls apart

Saint Herblain (France), May 1 6 , 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the United Arab Emirates (UAE) granted emergency use authorization for Valneva's inactivated, adjuvanted COVID-19 vaccine, VLA2001.

Valneva Receives Emergency Use Authorization from the United Arab Emirates for its Inactivated COVID-19 Vaccine

Valneva SE (NASDAQ:VALN ) Q1 2022 Earnings Conference Call May 5, 2022 10:00 AM ET Company Participants Thomas Lingelbach - Chief Executive Officer Peter Buhler - Chief Financial Officer Franck Grimaud - Chief Business Officer Conference Call Participants Samir Devani - Rx Securities Maury Raycroft - Jefferies Max Herrmann - Stifel Financial Corp. Evan Wang - Guggenheim Securities Jean-Jacques Le Fur - Bryan Garnier Franck Grimaud - Chief Business Officer Sebastiaan van der Schoot - Kempen & Company Thomas Lingelbach Good day, and welcome to our quarter one Financial Results and Corporate Update Call. Pleasure to be with you again today.

Valneva SE (VALN) CEO Thomas Lingelbach on Q1 2022 Results - Earnings Call Transcript

Valneva Reports Q1 2022 Results and Provides Corporate Updates

Pfizer Inc. PFE, +1.70% said Tuesday that an experimental Lyme disease vaccine it's developing with Valneva SE VALN, -13.23% will move into a Phase 3 clinical trial that includes children who are at least 5 years old, based on "positive" results among pediatric participants from the Phase 2 study. The Phase 3 trial is expected to begin in the third quarter.

Pfizer, Valneva plan to move Lyme disease vaccine candidate into Phase 3 trial

SAINT-HERBLAIN, France & NEW YORK--(BUSINESS WIRE)--Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE) today reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15. Based on these new results, Valneva and Pfizer plan to proceed with inclusion of pediatric participants in their planned Phase 3 trial. The trial will evaluate VLA15 in adults and pediatric subjects 5 years of age and above and is expected to be

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

Saint - Herblain (France), April 2 6 , 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced an agreement to increase the principal amount of its existing $60 million debt financing agreement with funds managed by leading US-based healthcare investment firms Deerfield Management Company and OrbiMed. This extension will provide Valneva immediate access to $20 million, with an additional $20 million available upon potential conditional approval of its inactivated COVID-19 vaccine candidate, VLA2001, by the European Medicines Agency. The increased funding will be used to further invest in R&D, including market access preparations for Valneva's chikungunya vaccine candidate, VLA1553.

Valneva Announces Upsized Financing Arrangement with Leading US Healthcare Funds Deerfield and OrbiMed

Saint Herblain (France), April 25 , 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today provided an update on the rolling review process of its inactivated, COVID-19 vaccine candidate, VLA2001, with the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”).

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