SEC Form 20-F filed by Valneva SE

With this extension, IXCHIQ®, the first vaccine against the chikungunya virus (CHIKV), is now available for administration for individuals 12 years of age and older in the European Union (EU). Saint Herblain (France), April 1, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that the European Commission (EC) has granted marketing authorization in Europe for Valneva's single-dose vaccine, IXCHIQ®, for the prevention of disease caused by the chikungunya virus in individuals 12 years of age and older. This label extension complements the adult marketing authorization in Europe Valneva received in July 20241. With this approval, IXCHIQ® becomes available

Saint Herblain (France), March 31, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that it has submitted a label extension application to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) to potentially expand the use of its chikungunya vaccine, IXCHIQ®, currently approved in adults1, to adolescents aged 12 to 17 years in the UK. This submission follows the recent positive opinion of the European Medicines Agency (EMA) on extension of IXCHIQ® label to adolescents in the European Union (EU)2. IXCHIQ® is the world's first licensed chikungunya vaccine available to address this significant unmet medical need. It i

Saint-Herblain (France), March 26, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA) ("Valneva" or the "Company"), a specialty vaccine company, today announces that it has filed a prospectus supplement as part of the renewal of its registration statement on Form F-3, filed on March 25, 2025 with the U.S. Securities and Exchange Commission ("SEC") relating to its existing At-the-Market offering facility (the "ATM Program"), which was originally entered into in August 2022 and has not been utilized to-date. Pursuant to this financing program, the Company has the option to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $75.0 million

H.C. Wainwright initiated coverage of Valneva SE with a rating of Buy and set a new price target of $34.00

6-K - Valneva SE (0001836564) (Filer)

6-K - Valneva SE (0001836564) (Filer)

6-K - Valneva SE (0001836564) (Filer)

Saint-Herblain (France), June 26, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Board of Directors were approved by the shareholders at its Combined General Meeting (CGM) held today in Lyon, France. Among the adopted resolutions were approval of the 2023 financial statements, delegations for the management board to increase Valneva's share capital and/or issue financial instruments, and the appointment of a new director to its Board. Ms. Danièle Guyot-Caparros was appointed to Valneva's Board of Directors for a three-year term. Ms. Guyot-Caparros has a proven track record in finance and business

Saint-Herblain (France), May 21, 2024 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced the appointment of Dr. Hanneke Schuitemaker, Ph.D. as Chief Scientific Officer (CSO) and Executive Committee member, effective June 3, 2024. Valneva decided to complement its Executive Team with an accomplished R&D leader to oversee the further evolution of the Company´s R&D portfolio. Specifically, Dr. Schuitemaker will focus on accelerating Valneva's pre-clinical and translational R&D activities in support of the Company's strategic ambition to provide first-, best- or only-in-class vaccine solutions. Dr. Schuitemaker brings more than two decades of experience in vacc

Saint-Herblain (France), June 21, 2023 – Valneva SE (NASDAQ:VALN, 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 today in Lyon, France. Among the adopted resolutions were approval of the 2022 financial statements, delegations for the management board to increase Valneva's share capital and/or issue financial instruments, as well as the appointment of a new Supervisory Board member and the reappointment of two of them. Dr Kathrin U Jansen, Ph.D., a German national with over 30 years of vaccine R&D experience, was appointed to Valneva's Supervisory

Met 2024 growth targets for product sales (+13% vs 2023) and total revenues (+10% vs 2023)Strong year-end cash position of €168.3 million including sale of Priority Review Voucher1, successful private placement and 67% reduction in operating cash burnSubstantial clinical and regulatory progress in 2024; further data readouts, product approvals and label extensions anticipated in 20252025 outlook reflects solid revenue growth and positive commercial cash flows to support strategic R&D investments with lower operating cash burn Saint-Herblain (France), March 20, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today reported its consolidated financial results for the y

 Nine-Month Key Financial Highlights Total revenues of €116.6 million, including product sales of €112.5 millionNet Profit of €24.7 million, including proceeds from the Priority Review Voucher (PRV)1 sale Operating profit of €34.2 million compared to an operating loss of €57.2 million in the first nine-months of 2023 Cash position of €156.3 million Includes €61.2 million in gross proceeds from recent private placement2Lower cash burn expected in the second half of 2024 as cost contributions to the agreed R&D budget for partnered Lyme disease program were completed in the second quarter of the year Full-year 2024 Financial Guidance Narrowed Expected total product sales according to guidan

 First-Half Sales Performance in Line with Full-Year 2024 Guidance Total revenues of €70.8 million, including product sales of €68.3 million, in line with anticipated supply and sales phasingNet Profit of €34.0 million, including proceeds from PRV sale Operating profit of €46.7 million compared to an operating loss of €35.0 million in the first half of 2023 Cash position of €131.4 million  Substantially lower cash burn expected in the second half of 2024 as Valneva completed its cost contributions to the agreed R&D budget for its partnered Lyme disease program in the second quarterSignificantly extended cash runway with update of debt financing agreement1 Full-year 2024 Financial

SC 13D/A - Valneva SE (0001836564) (Subject)

SC 13G/A - Valneva SE (0001836564) (Subject)

SC 13D/A - Valneva SE (0001836564) (Subject)