Grundläggande statistik
| CIK | 1836564 |
SEC Filings
All companies that sell securities in the United States must register with the Securities and Exchange Commission (SEC) and file reports on a regular basis.
These reports include company annual reports (10K, 10Q), news updates (8K), investor presentations (found in 8Ks), insider trades (form 4), ownership reports (13D, and 13G), and reports related to the specific securities sold, such as registration statements and prospectus. This page shows recent SEC filings related to Valneva SE
SEC Filings (Chronological Order)
Denna sida innehåller en komplett, kronologisk lista över SEC-arkiveringar, exklusive ägande-arkiveringar som vi tillhandahåller på andra ställen.
| June 5, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: June 4, 2026 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) Îlot Saint-Joseph, Bureaux Convergence 12ter Quai Perrache 69002 Lyon, France (Address o |
|
| June 5, 2026 |
Valneva Announces Availability of Documentation for its Annual General Meeting Valneva Announces Availability of Documentation for its Annual General Meeting Lyon (France), June 4, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company (“the Company”), today announced the availability of documentation for its Annual General Meeting (“the Meeting”) to be held on June 25, 2026 at 2:00 p. |
|
| June 4, 2026 |
As filed with the Securities and Exchange Commission on June 4, 2026 As filed with the Securities and Exchange Commission on June 4, 2026 Registration No. |
|
| June 4, 2026 |
Valneva SE F-3 Exhibit 107 Calculation of Filing Fee Tables Form F-3 (Form Type) Valneva SE (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Carry Forward Form Type Carry Forward File Number Carry Forward Initial effective date Filing Fee Previously Paid In Connection with Unsold Securities to be Carried Forward Newly Registered Securities Fees to Be Paid Equity Ordinary Shares, nominal value EUR 0. |
|
| June 1, 2026 |
Valneva to Participate at U.S. and European Investor Conferences in June Valneva to Participate at U.S. and European Investor Conferences in June Lyon (France), May 28, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and hold investor meetings at several upcoming investor conferences in the United States and Europe in June 2026. Key topics for discussion include Valneva’s commer |
|
| June 1, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: May 28, 2026 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) Îlot Saint-Joseph, Bureaux Convergence 12ter Quai Perrache 69002 Lyon, France (Address o |
|
| May 13, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: May 13, 2026 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) Îlot Saint-Joseph, Bureaux Convergence 12ter Quai Perrache 69002 Lyon, France (Address o |
|
| May 13, 2026 |
Valneva Reports First Quarter 2026 Financial Results and Provides Corporate Updates VALNEVA SE Îlot Saint-Joseph, Bureaux Convergence, Bât. A, 12 ter Quai Perrache 69002 Lyon, France Valneva Reports First Quarter 2026 Financial Results and Provides Corporate Updates •Total product sales of €30.5 million •Cash position of €105.3 million as of end March 2026, excluding proceeds from successful reserved offering completed in April 20261 •Program launched in April to further reduce o |
|
| May 13, 2026 |
1 Unaudited interim condensed consolidated financial statements as at March 31, 2026 Valneva SE I. |
|
| May 5, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: May 5, 2026 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) Îlot Saint-Joseph, Bureaux Convergence 12ter Quai Perrache 69002 Lyon, France (Address of |
|
| May 5, 2026 |
Valneva to Report First Quarter 2026 Consolidated Financial Results on May 13, 2026 Valneva to Report First Quarter 2026 Consolidated Financial Results on May 13, 2026 Lyon (France), May 05, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it will report its first quarter 2026 financial results on Wednesday, May 13, 2026. |
|
| April 30, 2026 |
rra Exhibit 99.3 FORM OF REGISTRATION RIGHTS AGREEMENT THIS REGISTRATION RIGHTS AGREEMENT (this “Agreement”), dated as of April 29, 2026, is entered into by and among Valneva SE, a Societas Europaea incorporated under the laws of France (the “Company”), and the several investors signatory hereto (individually as an “Investor” and collectively together with their respective permitted assigns, the “ |
|
| April 30, 2026 |
FORM OF SECURITIES PURCHASE AGREEMENT Exhibit 99.1 FORM OF SECURITIES PURCHASE AGREEMENT This SECURITIES PURCHASE AGREEMENT (this “Agreement”) is dated as of April 29, 2026, by and among Valneva SE, a Societas Europaea incorporated under the laws of France (the “Company”), and each of the entities listed on Exhibit A attached to this Agreement (each, an “Investor” and together, the “Investors”). WHEREAS, the Company and the Investors |
|
| April 30, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of April 2026 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) Îlot Saint-Joseph, Bureaux Convergence 12ter Quai Perrache 69002 Lyon, France (Address of |
|
| April 30, 2026 |
Valneva Announces the Successful Completion of a €84 million Reserved Offering VALNEVA SE Îlot Saint-Joseph, Bureaux Convergence, Bât. A, 12 ter Quai Perrache 69002 Lyon, France Valneva Announces the Successful Completion of a €84 million Reserved Offering Lyon (France), April 30, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (“Valneva” or the “Company”), a specialty vaccine company, announces the successful completion of an €84 million (including share issue premium |
|
| March 26, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: March 26, 2026 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) Îlot Saint-Joseph, Bureaux Convergence 12ter Quai Perrache 69002 Lyon, France (Address |
|
| March 26, 2026 |
Valneva to Participate in Multiple Events at the 26th World Vaccine Congress in Washington DC Valneva to Participate in Multiple Events at the 26th World Vaccine Congress in Washington DC Lyon (France), March 26, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced its participation in the upcoming 26th World Vaccine Congress, which will take place from March 31 to April 2, 2026 at the Walter E. |
|
| March 23, 2026 |
Pfizer and Valneva Announce Lyme Disease Vaccine Candidate Demonstrates Strong Efficacy in Phase 3 VALOR Trial •Vaccine candidate PF-07307405 (LB6V) demonstrated more than 70% efficacy in preventing Lyme disease in individuals aged five years and above •The investigational vaccine candidate was well tolerated with no safety concerns identified at time of analysis •Overall, results strengthen confidence in the vaccine candidate and Pfizer is planning submissions to regulatory authorities New York, NY, and Lyon (France), March 23, 2026 – Pfizer Inc. |
|
| March 23, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of March 2026 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) Îlot Saint-Joseph, Bureaux Convergence 12ter Quai Perrache 69002 Lyon, France (Address of |
|
| March 18, 2026 |
Valneva Reports Full Year 2025 Audited Consolidated Financial Results Valneva Reports Full Year 2025 Audited Consolidated Financial Results •Total revenues of €174. |
|
| March 18, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: March 18, 2026 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) Îlot Saint-Joseph, Bureaux Convergence 12ter Quai Perrache 69002 Lyon, France (Address |
|
| March 17, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 13(d) OF THE SECURITIES EXC |
|
| March 17, 2026 |
Valneva SE (the “Company”) 2025-2028 Performance-based Free Share Plan Terms and Conditions Exhibit 4.54 Valneva SE (the “Company”) 2025-2028 Performance-based Free Share Plan Terms and Conditions 1. Background and purpose of the plan The Combined Shareholders’ Meeting of the Company held on June 25, 2025 (the “Shareholders’ Meeting”) decided under its 36th resolution to authorize the Company’s Board of Directors (the “Board”) to allocate free ordinary shares of the Company for the benef |
|
| March 17, 2026 |
Exhibit 4.18 ***Certain identified information has been omitted from this exhibit because it is both (i) not material and (ii) of the type that the Registrant treats as private or confidential. Such omitted information is indicated by brackets (“[***]”) in this exhibit.*** AMENDMENT No. 1 to Distribution Agreement effective as of 23 June 2025 by and between Valneva Austria GmbH and Seqirus GmbH Th |
|
| March 17, 2026 |
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We hereby consent to the incorporation by reference in the Registration Statement on Form F-3 (No. |
|
| March 17, 2026 |
CERTIFICATION BY THE PRINCIPAL EXECUTIVE OFFICER PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Thomas Lingelbach, Chief Execu |
|
| March 17, 2026 |
Exhibit 4.21 ***Certain identified information has been omitted from this exhibit because it is both (i) not material and (ii) of the type that the Registrant treats as private or confidential. Such omitted information is indicated by brackets (“[***]”) in this exhibit.*** AMENDMENT No. 1 to the MASTER COLLABORATION AGREEMENT between Valneva Austria GmbH and Institute Butantan and Fundação Butanta |
|
| March 17, 2026 |
VALNEVA SE Terms and conditions of the 2025 Employee Stock Option Plan Exhibit 4.46 VALNEVA SE Terms and conditions of the 2025 Employee Stock Option Plan 1. Preliminary statement 1.1The 2025 Employee Stock Option Plan governed by these Terms and Conditions (the “2025 ESOP”) aims to promote the interests of Valneva SE (“Valneva” or “the Company” and, together with its subsidiaries, the “Group”) by offering an incentive to the Beneficiary Employees (as defined in Sect |
|
| March 17, 2026 |
Exhibit 1.1 VALNEVA SE European company with a Board of Directors with a share capital of 26,081,613 Euros Registered office: Îlot Saint-Joseph, Bureaux Convergence Bât. A, 12 ter Quai Perrache, 69002 Lyon Identification N° 422 497 560 RCS Lyon (the Company) - ARTICLES OF ASSOCIATION As amended on February 12, 2026 This document is a free translation. In case of discrepancy between the French and |
|
| March 17, 2026 |
MASTER COLLABORATION AGREEMENT Confidential Exhibit 4.20 ***Certain identified information has been omitted from this exhibit because it is both (i) not material and (ii) of the type that the Registrant treats as private or confidential. Such omitted information is indicated by brackets (“[***]”) in this exhibit.*** MASTER COLLABORATION AGREEMENT concluded by and between: Valneva Austria GmbH, CIN: FN 389960 x I HG Wien, with i |
|
| March 17, 2026 |
Exhibit 4.22 ***Certain identified information has been omitted from this exhibit because it is both (i) not material and (ii) of the type that the Registrant treats as private or confidential. Such omitted information is indicated by brackets (“[***]”) in this exhibit.*** AMENDMENT No. 2 to the MASTER COLLABORATION AGREEMENT between Valneva Austria GmbH and Instituto Butantan and Fundação Butanta |
|
| March 17, 2026 |
DESCRIPTION OF SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 Exhibit 2.3 DESCRIPTION OF SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 The following description of the ordinary shares, the American Depositary Shares and the articles of association, or bylaws, of Valneva SE (“Valneva,” the “Company,” “us” or “we”) is a summary and does not purport to be complete. This summary is subject to, and qualified in its entirety b |
|
| March 17, 2026 |
CERTIFICATION PURSUANT TO RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I Thomas Lingelbach, certify that: 1. |
|
| March 17, 2026 |
CERTIFICATION PURSUANT TO RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I, Peter Bühler, certify that: 1. |
|
| March 17, 2026 |
Exhibit 4.36 EXECUTION COPY LOAN AGREEMENT Dated as of October 6, 2025 among VALNEVA AUSTRIA GMBH (as Borrower and a Credit Party), VALNEVA SE (as Parent and an additional Credit Party), THE OTHER GUARANTORS SIGNATORY HERETO OR OTHERWISE PARTY HERETO FROM TIME TO TIME (as additional Credit Parties), BIOPHARMA CREDIT PLC (as Collateral Agent), BPCR LIMITED PARTNERSHIP (as a Lender) and BIOPHARMA CR |
|
| March 17, 2026 |
exhibit419-seqirusdistri DISTRIBUTION AGREEMENT - DUKORAL® - This Distribution Agreement ("Agreement") is entered into on 23 June 2025 (“Effective Date”) by and between: Valneva Sweden AB, CIN: [***], organized under the laws of Sweden, with its registered office at SE-105 21 Stockholm, Sweden, hereinafter referred to as “SUPPLIER”, and Seqirus GmbH, CIN: [***]organized under the laws of Germany, with its registered office at Stefan-George-Ring 23, 81929 München, Germany, hereinafter referred to as “DISTRIBUTOR”, (hereinafter each referred to as a “Party”, and collectively as the “Parties”). |
|
| March 17, 2026 |
AMENDMENT 3 to the MASTER COLLABORATION AGREEMENT Exhibit 4.23 Confidential ***Certain identified information has been omitted from this exhibit because it is both (i) not material and (ii) of the type that the Registrant treats as private or confidential. Such omitted information is indicated by brackets (“[***]”) in this exhibit.*** AMENDMENT 3 to the MASTER COLLABORATION AGREEMENT concluded by and between: Valneva Austria GmbH, CIN: [***], wit |
|
| March 17, 2026 |
exhibit417-seqirusdistri ***Certain identified information has been omitted from this exhibit because it is both (i) not material and (ii) of the type that the Registrant treats as private or confidential. |
|
| March 17, 2026 |
INSIDER TRADING POLICY POLICY OWNER: GENERAL COUNSEL MARCH 2026 Exhibit 19.1 INSIDER TRADING POLICY POLICY OWNER: GENERAL COUNSEL MARCH 2026 PREAMBLE As a result of the listing of the shares of Valneva SE (the “Company”) on Euronext Paris and Nasdaq, transactions in securities issued by the Company are subject to laws and regulations, including but not limited to French law, in particular the regulations of the French Financial Market Authority (hereinafter re |
|
| March 17, 2026 |
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We consent to the incorporation by reference in Registration Statement No. |
|
| March 17, 2026 |
CERTIFICATION BY THE PRINCIPAL FINANCIAL OFFICER PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Peter Bühler, Chief Financial |
|
| March 9, 2026 |
Valneva to Report Full Year 2025 Consolidated Financial Results on March 18, 2026 Valneva to Report Full Year 2025 Consolidated Financial Results on March 18, 2026 Lyon (France), March 9, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it will report its full year 2025 financial results on Wednesday, March 18, 2026. |
|
| March 9, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: March 9, 2026 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) Îlot Saint-Joseph, Bureaux Convergence 12ter Quai Perrache 69002 Lyon, France (Address |
|
| March 2, 2026 |
Valneva to Participate in Upcoming Investor Conferences Valneva to Participate in Upcoming Investor Conferences Lyon (France), March 2, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced its senior management will present and meet with investors at upcoming investor conferences in the United States and Europe. |
|
| March 2, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: March 2, 2026 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) Îlot Saint-Joseph, Bureaux Convergence 12ter Quai Perrache 69002 Lyon, France (Address |
|
| February 19, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: February 19, 2026 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) Îlot Saint-Joseph, Bureaux Convergence 12ter Quai Perrache 69002 Lyon, France (Addr |
|
| February 19, 2026 |
Valneva Reports Preliminary Unaudited 2025 Revenue and Cash and Provides 2026 Outlook Valneva Reports Preliminary Unaudited 2025 Revenue and Cash and Provides 2026 Outlook •Total Revenues of €174. |
|
| February 13, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: February 13, 2026 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) Îlot Saint-Joseph, Bureaux Convergence 12ter Quai Perrache 69002 Lyon, France (Addr |
|
| February 13, 2026 |
Valneva Provides Update on Recommendations for Use of IXCHIQ® in the United Kingdom Valneva Provides Update on Recommendations for Use of IXCHIQ® in the United Kingdom Lyon (France), February 13, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that following a review of the benefits and risks of the Company’s single-dose chikungunya vaccine, IXCHIQ®, the United Kingdom’s (UK) Commission on Human Medicines (CHM) has updated its recommendations for use of the vaccine. |
|
| February 3, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: February 3, 2026 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) Îlot Saint-Joseph, Bureaux Convergence 12ter Quai Perrache 69002 Lyon, France (Addre |
|
| February 3, 2026 |
Valneva and Instituto Butantan Announce Initiation of a Pilot Vaccination Campaign in Brazil with Single-Shot Chikungunya Vaccine IXCHIQ® Lyon (France), Sao Paulo, (Brazil), February 3, 2026 –Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company and Instituto Butantan, one of the world’s largest biomedical research centers, today announced the initiation of a Pilot Vaccination Strategy (PVS) in Brazil using Valneva’s single-shot chikungunya vaccine, IXCHIQ®. |
|
| January 20, 2026 |
Valneva Provides Update on Chikungunya Vaccine IXCHIQ® Valneva Provides Update on Chikungunya Vaccine IXCHIQ® •Company voluntarily withdraws IXCHIQ BLA and IND in the U. |
|
| January 20, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: January 19, 2026 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive off |
|
| January 9, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: January 9, 2026 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offi |
|
| January 9, 2026 |
Valneva to Meet with Investors during the J.P. Morgan Healthcare Conference Valneva to Meet with Investors during the J.P. Morgan Healthcare Conference Saint Herblain (France), January 09, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that members of its management team will meet one-on-one with existing shareholders and hold meetings with other institutional specialist investors during the 44th Annual J.P. Morgan Heal |
|
| December 31, 2025 |
Valneva and Serum Institute of India Announce Discontinuation of Chikungunya Vaccine License Agreement Saint-Herblain (France), Pune, (India), December 31, 2025 – Valneva SE (“Valneva” or “the Company”), a specialty vaccine company, and Serum Institute of India (SII), a Cyrus Poonawalla Group company today announced that they have mutually agreed to discontinue their license agreement for Valneva’s single-shot chikungunya vaccine. |
|
| December 31, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: December 31, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive of |
|
| December 11, 2025 |
Valneva Reports Positive Final Phase 2 Antibody Persistence and Safety Results in Children for its Chikungunya Vaccine IXCHIQ® •IXCHIQ® was well tolerated by children aged one to eleven years regardless of the dose or previous chikungunya infection (CHIKV) •Antibody levels remained high after twelve months in both dose groups, although more robust with the full dose •Twelve-month data continues to |
|
| December 11, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: December 11, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive of |
|
| November 28, 2025 |
Valneva to Further Consolidate its Operations in France Valneva to Further Consolidate its Operations in France •French operations to be concentrated at its Lyon site •Final consolidation of R&D in Vienna Saint-Herblain (France), November 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced a strategic initiative to optimize its organizational footprint in France as part of the Company’s ongoing efforts to increase operational effectiveness and position Valneva for long-term success. |
|
| November 28, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: November 28, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive of |
|
| November 26, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: November 26, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive of |
|
| November 26, 2025 |
Valneva Reports Nine-Month 2025 Financial Results and Provides Corporate Updates VALNEVA SE Campus Bio-Ouest | 6, Rue Alain Bombard 44800 Saint-Herblain, France Valneva Reports Nine-Month 2025 Financial Results and Provides Corporate Updates •Total revenues of €127. |
|
| November 20, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: November 20, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive of |
|
| November 20, 2025 |
1 Unaudited interim condensed consolidated financial statements as at September 30, 2025 Valneva SE I. |
|
| November 20, 2025 |
Valneva Reports Nine-Month 2025 Financial Results and Provides Corporate Updates VALNEVA SE Campus Bio-Ouest | 6, Rue Alain Bombard 44800 Saint-Herblain, France Valneva Reports Nine-Month 2025 Financial Results and Provides Corporate Updates •Total revenues of €127. |
|
| November 4, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: November 4, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive off |
|
| November 4, 2025 |
Valneva Reports Positive Results for Phase 1 Trial of Second-Generation Zika Vaccine Candidate Immune response successfully improved with second generation vaccine candidate Saint-Herblain (France), November 4, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive results of its Phase 1 clinical trial investigating the safety and immunogenicity of VLA1601, its second-generation adjuvanted inactivated vaccine candidate against the Zika virus (ZIKV). |
|
| October 6, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: October 6, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offi |
|
| October 6, 2025 |
Valneva Strengthens Financial Position by Refinancing Debt with Pharmakon Advisors and Provides Business Updates •New debt facility extends repayment from Q1 2026 to Q4 2030, lowers interest rate and provides access to additional capital for future business development •Company adjusts 2025 financial guidance and provides key business updates Saint-Herblain (France), October 6, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has entered into a debt facility for up to $500 million in non-dilutive financing with funds managed by Pharmakon Advisors, LP. |
|
| October 6, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: October 6, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offi |
|
| October 6, 2025 |
Valneva Strengthens Financial Position by Refinancing Debt with Pharmakon Advisors and Provides Business Updates •New debt facility extends repayment from Q1 2026 to Q4 2030, lowers interest rate and provides access to additional capital for future business development •Company adjusts 2025 financial guidance and provides key business updates Saint-Herblain (France), October 6, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has entered into a debt facility for up to $500 million in non-dilutive financing with funds managed by Pharmakon Advisors, LP. |
|
| October 6, 2025 |
Valneva Reports 95% Seroresponse Four Years After Single Shot of Chikungunya Vaccine IXCHIQ® Valneva Reports 95% Seroresponse Four Years After Single Shot of Chikungunya Vaccine IXCHIQ® •Long-lasting antibody persistence was comparable in older (65+) and younger adults •Long-term antibody persistence is a key competitive advantage for a vaccine targeting unpredictable outbreak diseases like chikungunya Saint-Herblain (France), September 30, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive antibody persistence data four years after vaccination with a single dose of its chikungunya vaccine IXCHIQ®. |
|
| October 6, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K/A REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: October 6, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive of |
|
| September 3, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: September 3, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive of |
|
| September 3, 2025 |
Valneva Reports Further Positive Phase 2 Safety and Valneva Reports Further Positive Phase 2 Safety and Immunogenicity Results for Lyme Disease Vaccine Candidate •Strong immune response after third yearly booster dose in children and adults •Significant anamnestic antibody response across all six serotypes •No safety concerns observed in any age group by independent Data Monitoring Committee (DMC), consistent with previous booster results. |
|
| August 25, 2025 |
Valneva Announces FDA’s Decision to Suspend License of Chikungunya Vaccine IXCHIQ® In the U.S. Valneva Announces FDA’s Decision to Suspend License of Chikungunya Vaccine IXCHIQ® In the U. |
|
| August 25, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: August 125 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offi |
|
| August 18, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: August 18, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offi |
|
| August 18, 2025 |
Valneva’s Chikungunya Vaccine IXCHIQ® Now Authorized in Canada for Individuals Aged 12 and Older Valneva’s Chikungunya Vaccine IXCHIQ® Now Authorized in Canada for Individuals Aged 12 and Older Saint Herblain (France), August 18, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that Health Canada has granted marketing authorization for its single-dose vaccine, IXCHIQ®, for the prevention of disease caused by the chikungunya virus in individuals aged 12 years and older. |
|
| August 12, 2025 |
Valneva Reports Half Year 2025 Financial Results and Provides Corporate Updates VALNEVA SE Campus Bio-Ouest | 6, Rue Alain Bombard 44800 Saint-Herblain, France Valneva Reports Half Year 2025 Financial Results and Provides Corporate Updates •Total revenues of €97. |
|
| August 12, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: August 12, 2025 Commission File Number: 001-40377 Valneva SE (Exact name of Registrant as specified in its charter and translation of Registrant’s name into English) France (Jurisdiction of inco |
|
| August 7, 2025 |
Valneva Announces Removal of FDA-Recommended Pause on Use of Chikungunya Vaccine IXCHIQ® in Elderly and Updates to the Prescribing Information Saint Herblain (France), August 7, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the FDA has removed its recommended pause in the use of IXCHIQ® in individuals 60 years of age and older and has approved updates to the Prescribing Information (PI) for IXCHIQ®. |
|
| August 7, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: August 7, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offic |
|
| July 11, 2025 |
Valneva Announces Lifting of European Medicines Agency’s Temporary Restriction on Use of Chikungunya Vaccine IXCHIQ® in Elderly Saint-Herblain, France, July 11, 2025 — Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) will lift the temporary restriction on vaccinating people aged 65 years and above after concluding a thorough review of Valneva’s single-dose chikungunya vaccine IXCHIQ® by EMA’s safety committee (PRAC). |
|
| July 11, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: July 11, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office |
|
| June 26, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: June 26, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office |
|
| June 26, 2025 |
Valneva Announces Exclusive Vaccine Marketing and Distribution Agreement for Germany with CSL Seqirus Saint-Herblain, France, June 26, 2025 – Valneva SE, (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced an exclusive agreement with CSL Seqirus, one of the world’s largest influenza vaccine companies, for the marketing and distribution of Valneva’s three proprietary vaccines in Germany. |
|
| June 25, 2025 |
Valneva Announces Successful Outcome of its Annual General Meeting, Confirms FY 2025 guidance Valneva Announces Successful Outcome of its Annual General Meeting, Confirms FY 2025 guidance Saint-Herblain (France), June 25, 2025 – Valneva SE (Nasdaq: VALN; Euronext 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 Annual General Meeting held today in Lyon, France. |
|
| June 25, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: June 25, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office |
|
| June 5, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: June 5, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office) |
|
| June 5, 2025 |
Valneva Reports Positive Six-Month Antibody Persistence and Safety Phase 2 Results in Children for its Single-Shot Chikungunya Vaccine IXCHIQ® •IXCHIQ® was well tolerated by children aged one to eleven years regardless of the dose or previous chikungunya infection (CHIKV) •Antibody levels remained high after six months in both dose groups, although more robust with the full dose •Six-month data co |
|
| June 4, 2025 |
Valneva Announces Availability of Documentation for its Combined Shareholder Meeting and Provides Corporate Update Saint-Herblain (France), June 4, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company (“the Company”), today announced the availability of documentation for its Combined General Meeting (“the Meeting”) to be held on June 25, 2025 at 2:00 p. |
|
| June 4, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: June 4, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office) |
|
| May 27, 2025 |
Valneva to Participate at U.S. and European Investor Conferences in June Valneva to Participate at U.S. and European Investor Conferences in June Saint-Herblain (France), May 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and hold investor meetings at several upcoming investor conferences in the United States and Europe in June 2025. Key topics for discussion include Valnev |
|
| May 27, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: May 27, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office) |
|
| May 12, 2025 |
Valneva Provides Update on Recommended Use of IXCHIQ® by Elderly Individuals in the United States Valneva Provides Update on Recommended Use of IXCHIQ® by Elderly Individuals in the United States Saint Herblain (France), May, 12 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U. |
|
| May 12, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: May 12, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office) |
|
| May 7, 2025 |
Valneva Reports First Quarter 2025 Financial Results and Provides Corporate Updates Valneva Reports First Quarter 2025 Financial Results and Provides Corporate Updates •Total revenues of €49. |
|
| May 7, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: May 7, 2025 Commission File Number: 001-40377 VALNEVA SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office) |
|
| May 7, 2025 |
Valneva Provides Update Following European Medicines Agency Announcement on Use of IXCHIQ® in Elderly Saint Herblain (France), May, 07 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) has started a review of Valneva’s single-dose live attenuated chikungunya vaccine IXCHIQ® based on reports of serious adverse events (SAEs) in elderly people. |
|
| April 28, 2025 |
Valneva Provides Update on Recommendation for Use of Its Chikungunya Vaccine by French Authorities Valneva Provides Update on Recommendation for Use of Its Chikungunya Vaccine by French Authorities Saint Herblain (France), April 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that France’s national public health agency, the Haute Autorité de Santé (HAS), has updated its recommendation for use of Valneva’s single-dose chikungunya vaccine IXCHIQ® for the prevention of disease caused by the chikungunya virus (CHIKV) following reports of serious adverse events (SAEs) in elderly people with comorbidities during the ongoing vaccination campaign in La Reunion and Mayotte. |
|
| April 28, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: April 28, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offic |
|
| April 18, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: April 18, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offic |
|
| April 18, 2025 |
Valneva Provides Update on ACIP Recommendation for its Chikungunya Vaccine IXCHIQ® Among U. |
|
| April 16, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: April 16, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offic |
|
| April 16, 2025 |
Valneva to Participate in Multiple Events at the 25th World Vaccine Congress, including a Presentation on its Chikungunya Vaccine IXCHIQ® Saint-Herblain (France), April 16, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced its presence at the forthcoming 25th World Vaccine Congress, which will take place from April 21-24, 2025 at the Walter E. |
|
| April 14, 2025 |
Valneva Receives First Marketing Authorization for IXCHIQ® in a Chikungunya Endemic Country Valneva Receives First Marketing Authorization for IXCHIQ® in a Chikungunya Endemic Country Saint Herblain (France), April 14, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company today announced that the Brazilian Health Regulatory Agency (ANVISA) has granted marketing authorization to its single-dose vaccine IXCHIQ® for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. |
|
| April 14, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: April 14, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offic |
|
| April 9, 2025 |
Valneva and LimmaTech Announce First Vaccination in Phase 2 Infant Study of Tetravalent Shigella Vaccine Candidate S4V2 Saint Herblain (France) and Schlieren (Zurich), April 9, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the first participant has been vaccinated in a Phase 2 infant safety and immunogenicity study of Shigella4V2 (S4V2), the world’s most clinically advanced tetravalent bioconjugate vaccine candidate against shigellosis. |
|
| April 9, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: April 9, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office |
|
| April 1, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: April 4, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office |
|
| April 1, 2025 |
Valneva’s Chikungunya Vaccine IXCHIQ® Now Authorized in EU for Adolescents Aged 12 and Above Valneva’s Chikungunya Vaccine IXCHIQ® Now Authorized in EU for Adolescents Aged 12 and Above April 1, 2025 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). |
|
| March 31, 2025 |
Valneva Submits Adolescent Label Extension Application for its Chikungunya Vaccine, IXCHIQ®, to UK MHRA Saint Herblain (France), March 31, 2025 – Valneva SE (Nasdaq: VALN; Euronext 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. |
|
| March 31, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: March 31, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offic |
|
| March 31, 2025 |
March 31, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Chris Edwards Re: Valneva SE Registration Statement on Form F-3 Filed March 25, 2025 File No. 333- 286071 Acceleration Request Requested Date: April 2, 2025 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the |
|
| March 28, 2025 |
March 28, 2025 Thomas Lingelbach Chief Executive Officer Valneva SE 6 rue Alain Bombard 44800 Saint-Herblain France Re: Valneva SE Registration Statement on Form F-3 Filed March 25, 2025 File No. |
|
| March 25, 2025 |
Valneva SE - F-3 Exhibit 107 Calculation of Filing Fee Tables Form F-3 (Form Type) Valneva SE (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Carry Forward Form Type Carry Forward File Number Carry Forward Initial Effective Date Filing Fee Previously Paid in Connection with Unsold Securities to be Carried Forward Newly Registered Securities Fees to Be Paid Equity Ordinary shares, €0. |
|
| March 25, 2025 |
As filed with the Securities and Exchange Commission on March 24, 2025 Registration No. |
|
| March 25, 2025 |
Valneva Announces Filing of 2024 Universal Registration Document and US Form 20-F Valneva Announces Filing of 2024 Universal Registration Document and US Form 20-F March 25, 2025 Saint-Herblain (France), March 25, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today the filing, on March 24, 2025, of its 2024 Universal Registration Document (URD) with the French Financial Markets Authority (AMF) under the filing number D. |
|
| March 25, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: March 25, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offic |
|
| March 25, 2025 |
AMENDED AND RESTATED OPEN MARKET SALE AGREEMENTSM Valneva SE - F-3 Exhibit 1.2 AMENDED AND RESTATED OPEN MARKET SALE AGREEMENTSM March 24, 2025 JEFFERIES LLC 520 Madison Avenue New York, New York 10022 Ladies and Gentlemen: Valneva SE, a Societas Europaea incorporated under the laws of France, having its registered office at 6 rue Alain Bombard, 44800 Saint-Herblain, France and registered with the registre du commerce et des sociétés of Nantes un |
|
| March 24, 2025 |
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We consent to the incorporation by reference in Registration Statement No. |
|
| March 24, 2025 |
MASTER COLLABORATION AND LICENSE AGREEMENT concluded by and between: [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) CUSTOMARILY AND ACTUALLY TREATED BY THE REGISTRANT AS PRIVATE OR CONFIDENTIAL. |
|
| March 24, 2025 |
Y (CfP-3i) → New scope & members [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) CUSTOMARILY AND ACTUALLY TREATED BY THE REGISTRANT AS PRIVATE OR CONFIDENTIAL. |
|
| March 24, 2025 |
Valneva SE (the “Company”) 2024-2027 Free Share Plan Terms and Conditions Valneva SE (the “Company”) 2024-2027 Free Share Plan Terms and Conditions 1.Background and purpose of the plan On December 20, 2023, the General Meeting of Valneva SE’s shareholders decided under its 23rd resolution to grant the Company’s Board of Directors (the “Board”) all powers necessary to decide the granting and issuance of free ordinary shares (“FS”) for the benefit of corporate officers or |
|
| March 24, 2025 |
CERTIFICATION BY THE PRINCIPAL FINANCIAL OFFICER PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Peter Bühler, Chief Financial |
|
| March 24, 2025 |
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We hereby consent to the incorporation by reference in the Registration Statement on Form F-3 (No. |
|
| March 24, 2025 |
Policy for Handling of Insider Information and Stock Trading by Employees and Directors Policy for Handling of Insider Information and Stock Trading by Employees and Directors 1. |
|
| March 24, 2025 |
VALNEVA SE Terms and conditions of the 2024 Senior Leadership Group Stock Option Plan VALNEVA SE Terms and conditions of the 2024 Senior Leadership Group Stock Option Plan 1. |
|
| March 24, 2025 |
VALNEVA SE European company with a Board of Directors with a share capital of 24,378,228. |
|
| March 24, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 13(d) OF THE SECURITIES EXC |
|
| March 24, 2025 |
EXECUTION COPY [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) CUSTOMARILY AND ACTUALLY TREATED BY THE REGISTRANT AS PRIVATE OR CONFIDENTIAL. |
|
| March 24, 2025 |
VALNEVA SE Terms and conditions of the 2024 Employee Stock Option Plan VALNEVA SE Terms and conditions of the 2024 Employee Stock Option Plan 1. Preliminary statement 1.1The 2024 Employee Stock Option Plan governed by these Terms and Conditions (the “2024 ESOP”) is aiming at promoting the interests of Valneva SE (“Valneva” or “the Company”) by offering an incentive to the Beneficiary Employees (as defined below) to acquire shares in the Company. The objective is to m |
|
| March 24, 2025 |
DESCRIPTION OF SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 Exhibit 2.3 DESCRIPTION OF SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 The following description of the ordinary shares, the American Depositary Shares and the articles of association, or bylaws, of Valneva SE (“Valneva,” the “Company,” “us” or “we”) is a summary and does not purport to be complete. This summary is subject to, and qualified in its entirety b |
|
| March 24, 2025 |
CERTIFICATION BY THE PRINCIPAL EXECUTIVE OFFICER PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Thomas Lingelbach, Chief Execu |
|
| March 24, 2025 |
Valneva Responds to French Government’s Call for Vaccine Supply of IXCHIQ® against Chikungunya Outbreak in La Réunion Saint Herblain (France), March 24, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it is responding to the chikungunya outbreak that is rapidly intensifying in France’s Island of La Réunion with its vaccine IXCHIQ®. |
|
| March 24, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: March 24, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offic |
|
| March 24, 2025 |
CERTIFICATION PURSUANT TO RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I Thomas Lingelbach, certify that: 1. |
|
| March 24, 2025 |
Exhibit 4.16 CERTAIN INFORMATION HAS BEEN EXCLUDED FROM THIS AGREEMENT (INDICATED BY “[***]”) BECAUSE SUCH INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30 1. REQUISITION NUMBER 1000186747 PAGE 1 OF 9 2. CONTRACT NO. SPE2DP-25-D-0002 3. AWARD/E |
|
| March 24, 2025 |
CERTIFICATION PURSUANT TO RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I, Peter Bühler, certify that: 1. |
|
| March 20, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: March 20, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offic |
|
| March 20, 2025 |
Valneva Reports Full Year 2024 Results and Provides Business Updates and Outlook Valneva Reports Full Year 2024 Results and Provides Business Updates and Outlook •Met 2024 growth targets for product sales (+13% vs 2023) and total revenues (+10% vs 2023) •Strong year-end cash position of €168. |
|
| March 3, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: March 3, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office |
|
| March 3, 2025 |
Valneva to Present at Upcoming TD Cowen and Van Lanschot Kempen Healthcare Investor Conferences Valneva to Present at Upcoming TD Cowen and Van Lanschot Kempen Healthcare Investor Conferences Saint-Herblain (France), March 3, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today announced that its senior management will participate at upcoming investor conferences in the United States and Europe. |
|
| February 28, 2025 |
Valneva Receives EMA’s Positive CHMP Opinion for Adolescent Label Extension for Chikungunya Vaccine IXCHIQ® If granted, IXCHIQ® will become the first vaccine against the chikungunya virus (CHIKV) available in the EU for adolescents 12 years of age and older Saint Herblain (France), February 28, 2025 – 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 adopted a positive opinion recommending authorization of a label extension for IXCHIQ®, Valneva’s single-dose vaccine for the prevention of disease caused by the chikungunya virus, to individuals 12 years of age and older. |
|
| February 28, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: February 28, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive of |
|
| February 18, 2025 |
Valneva Reports Preliminary Unaudited 2024 Revenue and Cash and Provides 2025 Outlook Valneva Reports Preliminary Unaudited 2024 Revenue and Cash and Provides 2025 Outlook February 18, 2025 •Met 2024 growth targets for sales revenue (+13% vs 2023) and total revenues (+10% vs 2023) •Strong year-end cash position of €168. |
|
| February 18, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: February 18, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive of |
|
| February 5, 2025 |
Valneva Receives Marketing Authorization in the UK for the World’s First Chikungunya Vaccine, IXCHIQ® Saint Herblain (France), February 5, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for the world’s first and only chikungunya vaccine, IXCHIQ®. |
|
| February 5, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: February 5, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive off |
|
| January 30, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: January 30, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive off |
|
| January 30, 2025 |
Valneva Announces New IXIARO® Supply Contract with the U.S. Government Worth a Minimum of $32.8 Million Saint Herblain (France), January 30, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the signing of a new $32.8 million contract with the United States (U.S.) Department of Defense (DoD) for the supply of its Japanese encephalitis (JE) vaccine, |
|
| January 23, 2025 |
Valneva Reports Positive Phase 2 Results in Children for its Chikungunya Vaccine and Announces Phase 3 Dose Decision Saint-Herblain (France), January 22, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced positive results for its Phase 2 clinical trial evaluating the safety and immunogenicity of two different dose levels of its single-shot chikungunya vaccine, IXCHIQ®, in 304 children. |
|
| January 23, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: January 23, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive off |
|
| January 21, 2025 |
Valneva Reports High Sustained Immune Response in Adolescents One Year After Single Vaccination with its Chikungunya Vaccine January 20, 2025 Saint-Herblain (France), January 20, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported further positive Phase 3 data in adolescents for its single-shot chikungunya virus (CHIKV) vaccine, IXCHIQ®, which showed a sustained 98. |
|
| January 21, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: January 21, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive off |
|
| January 7, 2025 |
Valneva to Meet with Investors during the J.P. Morgan Healthcare Conference Valneva to Meet with Investors during the J.P. Morgan Healthcare Conference January 6, 2025 Saint Herblain (France), January 6, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that members of its management team will meet one-on-one with existing shareholders and hold meetings with other institutional specialist investors during the 43rd Annual J |
|
| January 7, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: January 7, 2025 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offi |
|
| December 19, 2024 |
EXHIBIT 99.1 Valneva Successfully Expands Access to Asia for its Chikungunya Vaccine with Serum Institute of India Saint-Herblain (France), Pune, (India), December 19, 2024 – Valneva SE (“Valneva” or “the Company”), a specialty vaccine company, and Serum Institute of India (SII), the world’s largest manufacturer of vaccines by number of doses, today announced an exclusive license agreement for Val |
|
| December 19, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: December 19, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive of |
|
| December 4, 2024 |
6-K 1 f6k120424.htm FORM 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: December 4, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Addre |
|
| December 4, 2024 |
EXHIBIT 99.1 Valneva Announces Peer-Reviewed Publication on the Global Health and Economic Burden of Chikungunya in The British Medical Journal Saint-Herblain (France), December 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the publication of an article on the global health and economic burden of mosquito-borne disease chikungunya in The Bri |
|
| December 3, 2024 |
EXHIBIT 99.1 Valneva Reports Positive Three-Year Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ® Antibody levels remained high at 96% seroresponse in line with the two-year persistence data This long-lasting antibody persistence was comparable in older (65+) and younger adults Saint-Herblain (France), December 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a sp |
|
| December 3, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: December 3, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive off |
|
| November 26, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: November 26, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive of |
|
| November 26, 2024 |
EXHIBIT 99.1 Valneva Submits Label Extension Application for its Chikungunya Vaccine, IXCHIQ®, to the U.S. FDA To potentially include adolescents and antibody persistence up to two years Saint Herblain (France), November 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted a label extension application to the U.S. Food and Dr |
|
| November 13, 2024 |
EdgarFiling EXHIBIT 99.2 Valneva and LimmaTech Announce First Vaccination in Phase 2b Human Challenge Study of Tetravalent Shigella Vaccine Candidate S4V2 Saint Herblain (France) and Schlieren (Zurich), November 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention |
|
| November 13, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: November 13, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive of |
|
| November 13, 2024 |
Valneva to Present and Hold Investor Meetings at Upcoming U.S. and European Healthcare Conferences EXHIBIT 99.1 Valneva to Present and Hold Investor Meetings at Upcoming U.S. and European Healthcare Conferences Saint-Herblain (France), November 12, 2024 – 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 upcoming investor conferences in the United |
|
| November 7, 2024 |
1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: November 7, 2024 Commission File Number: 001-40377 VALNEVA SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive o |
|
| November 7, 2024 |
Valneva Reports Nine-Month 2024 Financial Results and Provides Corporate Updates VALNEVA SE Campus Bio-Ouest | 6, Rue Alain Bombard 44800 Saint-Herblain, France Valneva Reports Nine-Month 2024 Financial Results and Provides Corporate Updates Nine-Month Key Financial Highlights •Total revenues of €116. |
|
| October 21, 2024 |
Valneva to Present on Chikungunya at Several Leading Scientific Conferences EXHIBIT 99.1 Valneva to Present on Chikungunya at Several Leading Scientific Conferences Saint-Herblain (France), October 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today that members of its senior leadership team will present datasets on the world’s first and only approved chikungunya vaccine, IXCHIQ®, at several leading scientific conference |
|
| October 21, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: October 21, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive off |
|
| October 16, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: October 16, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive off |
|
| October 16, 2024 |
EXHIBIT 99.1 Valneva and LimmaTech Awarded FDA Fast Track Designation for Tetravalent Shigella Vaccine Candidate S4V Saint Herblain (France) and Schlieren (Zurich), October 16, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced |
|
| October 10, 2024 |
Valneva Hosts Investor Day in New York City Live event and webcast TODAY at 10 AM ET EXHIBIT 99.1 Valneva Hosts Investor Day in New York City Live event and webcast TODAY at 10 AM ET Saint Herblain (France), October 10, 2024 –Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, is hosting an investor day today in New York City to discuss the Company’s key value drivers over the next 12-18 months and beyond. Valneva’s Chief Executive Officer Thomas Lingelbac |
|
| October 10, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: October 10, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive off |
|
| October 3, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: October 3, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offi |
|
| October 3, 2024 |
Valneva to Host Investor Day in New York on Thursday, October 10, 2024 at 10:00 AM ET EXHIBIT 99.1 Valneva to Host Investor Day in New York on Thursday, October 10, 2024 at 10:00 AM ET Saint Herblain (France), October 3, 2024 –Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it will host an investor day at the Lotte New York Palace Hotel in New York, NY on Thursday, October 10, 2024 at 10:00 AM ET (4:00 pm CET). The meeting will be c |
|
| September 20, 2024 |
Exhibit 99.1 JOINT FILING AGREEMENT The undersigned acknowledges and agrees that the foregoing statement on Schedule 13D is filed on behalf of each of the undersigned and that all subsequent amendments to this foregoing shall be filed on behalf of each of the undersigned without the necessity of filing additional joint filing agreements. The undersigned acknowledges that each shall be responsible |
|
| September 20, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 2 )* Valneva SE (Name of Issuer) Ordinary Shares, nominal value €0.15 per share (Title of Class of Securities) 92025Y103 (American Depositary Shares, each representing two ordinary shares) (CUSIP Number) Sophie Paquin Bpifrance Participations S.A. 6-8, boule |
|
| September 18, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: September 18, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive o |
|
| September 18, 2024 |
EXHIBIT 99.1 Valneva Submits Label Extension Applications for its Chikungunya Vaccine, IXCHIQ®, to EMA and Health Canada To potentially include adolescents and antibody persistence up to two years Saint Herblain (France), September 18, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted label extension applications to the Europe |
|
| September 13, 2024 |
Valneva Announces the Success of its Private Placement Raising approximately €60 Million VALNEVA SE Campus Bio-Ouest | 6, Rue Alain Bombard 44800 Saint-Herblain, France Valneva Announces the Success of its Private Placement Raising approximately €60 Million Saint-Herblain (France), September 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (“Valneva” or the “Company”), a specialty vaccine company, today announces the successful pricing of its Private Placement (as defined below) for a final amount of €61,180,000. |
|
| September 13, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: September 13, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive o |
|
| September 13, 2024 |
VALNEVA SE Campus Bio-Ouest | 6, Rue Alain Bombard 44800 Saint-Herblain, France Valneva Announces the Launch of a Private Placement of Ordinary Shares for Approximately 60 Million Euros Saint-Herblain (France), September 12, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (“Valneva” or the “Company”), a specialty vaccine company, today announces its intention to issue, subject to market conditions, approximately 22. |
|
| September 3, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: September 3, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive of |
|
| September 3, 2024 |
EdgarFiling EXHIBIT 99.1 Valneva and Pfizer Report Further Positive Phase 2 Booster Results for Lyme Disease Vaccine Candidate VLA15-221 Phase 2 study: strong immune response shown one month after a second booster dose (month 31) in pediatric and adult populations Significant anamnestic antibody response observed across all six serotypes, consistent with previous results Favorable safety profile o |
|
| August 13, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: August 13, 2024 Commission File Number: 001-40377 Valneva SE (Exact name of Registrant as specified in its charter and translation of Registrant’s name into English) France (Jurisdiction of inco |
|
| August 13, 2024 |
Valneva Reports Half Year 2024 Financial Results and Provides Corporate Updates VALNEVA SE Campus Bio-Ouest | 6, Rue Alain Bombard 44800 Saint-Herblain, France Valneva Reports Half Year 2024 Financial Results and Provides Corporate Updates First-Half Sales Performance in Line with Full-Year 2024 Guidance •Total revenues of €70. |
|
| August 1, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: August 1, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offic |
|
| August 1, 2024 |
Exhibit 99.2 Valneva and LimmaTech Enter into a Strategic Partnership to Accelerate the Development of the World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate (“S4V”) August 01, 2024 Disclaimer This presentation does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, Valneva SE shares to any person in the USA or in any jurisdiction t |
|
| August 1, 2024 |
EXHIBIT 99.1 Valneva and LimmaTech Enter into a Strategic Partnership to Accelerate the Development of the World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate Valneva obtains exclusive worldwide license for LimmaTech’s S4V Shigella vaccine candidate and adds an attractive Phase 2 clinical asset to Valneva’s R&D pipeline LimmaTech to receive upfront payment, is eligible for futu |
|
| July 22, 2024 |
EXHIBIT 99.1 CEPI Expands Partnership with Valneva with a $41.3 Million Grant to Support Broader Access to the World’s First Chikungunya Vaccine Valneva to receive up to $41.3 million from CEPI and the European Union to expand access to chikungunya vaccine, IXCHIQ® Funding will support clinical trials in vulnerable groups, such as children and pregnant women Partnership will also support technolog |
|
| July 22, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: July 22, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office |
|
| July 18, 2024 |
Phase 3 VALOR Lyme Disease Trial: Valneva and Pfizer Announce Primary Vaccination Series Completion EXHIBIT 99.1 Phase 3 VALOR Lyme Disease Trial: Valneva and Pfizer Announce Primary Vaccination Series Completion Participants completed primary vaccination series (3 doses) with VLA15 Primary vaccination series to be followed by a booster approximately one year after completion New York, NY and Saint-Herblain (France), July 17, 2024 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext |
|
| July 18, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: July 18, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office |
|
| July 1, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: July 1, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office) |
|
| July 1, 2024 |
EXHIBIT 99.1 Valneva Receives Marketing Authorization in Europe for the World’s First Chikungunya Vaccine, IXCHIQ® Saint Herblain (France), July 1, 2024 – Valneva SE (Nasdaq: VALN; Euronext 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 diseas |
|
| June 27, 2024 |
EXHIBIT 99.1 Valneva Announces Successful Outcome of its Combined General Meeting and Appointment of a New Director to its Board Saint-Herblain (France), June 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext 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) he |
|
| June 27, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: June 27, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office |
|
| June 24, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: June 24, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office |
|
| June 24, 2024 |
Valneva Announces Health Canada Approval of the World’s First Chikungunya Vaccine, IXCHIQ® EXHIBIT 99.1 Valneva Announces Health Canada Approval of the World’s First Chikungunya Vaccine, IXCHIQ® Saint-Herblain (France), June 24, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that Health Canada has approved IXCHIQ®, Valneva’s single-dose vaccine for the prevention of disease caused by the chikungunya virus in individuals 18 years of ag |
|
| June 5, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: June 5, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office) |
|
| June 5, 2024 |
EXHIBIT 99.1 Valneva Announces Availability of Documentation for its Combined Shareholder Meeting and Provides Corporate Update Saint-Herblain (France), June 5, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company (“the Company”), today announced the availability of documentation for its Combined General Meeting (“the Meeting”) to be held on June 26, 2024 at 2:00 p.m. |
|
| June 4, 2024 |
Valneva to Present and Hold Investor Meetings at Upcoming Conferences in June EXHIBIT 99.1 Valneva to Present and Hold Investor Meetings at Upcoming Conferences in June Saint-Herblain (France), June 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that management will participate at several upcoming investor conferences in the United States and Europe during June 2024. Valneva will present and meet with global institutio |
|
| June 4, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: June 4, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office) |
|
| June 3, 2024 |
Valneva Announces Publication of Lyme Disease Phase 2 Trials in the Lancet Infectious Diseases EXHIBIT 99.1 Valneva Announces Publication of Lyme Disease Phase 2 Trials in the Lancet Infectious Diseases Saint-Herblain (France), June 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the results of two Phase 2 clinical trials of Lyme disease vaccine candidate, VLA15, were published in the peer-reviewed medical journal, The Lancet Infec |
|
| June 3, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: June 3, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office) |
|
| May 31, 2024 |
Valneva Receives EMA’s Positive CHMP Opinion for its Chikungunya Vaccine EXHIBIT 99.1 Valneva Receives EMA’s Positive CHMP Opinion for its Chikungunya Vaccine If approved, IXCHIQ® will become the first vaccine available in the EU against the chikungunya virus (CHIKV) Decision on EU marketing authorization expected in the third quarter of 2024 Saint Herblain (France), May 31, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today annou |
|
| May 31, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: May 31, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office) |
|
| May 21, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: May 21, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office) |
|
| May 21, 2024 |
Valneva Appoints Dr. Hanneke Schuitemaker, Ph.D. as Chief Scientific Officer EXHIBIT 99.1 Valneva Appoints Dr. Hanneke Schuitemaker, Ph.D. as Chief Scientific Officer Saint-Herblain (France), May 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext 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 Ex |
|
| May 13, 2024 |
EXHIBIT 99.1 Valneva Reports Further Positive Pivotal Phase 3 Data in Adolescents for its Single-Shot Chikungunya Vaccine Results Intended to Support Filing for Potential Label Extension for Use in Adolescents Saint-Herblain (France), May 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported further positive pivotal Phase 3 data in adolescents for i |
|
| May 13, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: May 13, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office) |
|
| May 7, 2024 |
Valneva Reports First Quarter 2024 Financial Results and Provides Corporate Updates VALNEVA SE Campus Bio-Ouest | 6, Rue Alain Bombard 44800 Saint-Herblain, France Valneva Reports First Quarter 2024 Financial Results and Provides Corporate Updates Q1 financial highlights •Total revenues of €32. |
|
| May 7, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: May 7, 2024 Commission File Number: 001-40377 VALNEVA SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office) |
|
| March 26, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: March 26, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offic |
|
| March 26, 2024 |
Valneva Initiates Phase 1 Trial of Second-Generation Zika Vaccine Candidate EXHIBIT 99.2 Valneva Initiates Phase 1 Trial of Second-Generation Zika Vaccine Candidate Saint-Herblain (France), March 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the initiation of a Phase 1 clinical trial to investigate the the safety and immunogenicity of VLA1601, its second-generation adjuvanted inactivated vaccine candidate against t |
|
| March 26, 2024 |
Valneva Announces Filing of 2023 Universal Registration Document and US Form 20-F EXHIBIT 99.1 Valneva Announces Filing of 2023 Universal Registration Document and US Form 20-F Saint-Herblain (France), March 25, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today the filing, on March 22, 2024, of its 2023 Universal Registration Document (URD) with the French Financial Markets Authority (AMF) under the filing number D.24-0157 and i |
|
| March 22, 2024 |
CONFIDENTIAL—DISCLOSURE PROHIBITED CONFIDENTIAL—DISCLOSURE PROHIBITED [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) CUSTOMARILY AND ACTUALLY TREATED BY THE REGISTRANT AS PRIVATE OR CONFIDENTIAL. |
|
| March 22, 2024 |
Execution Version [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) CUSTOMARILY AND ACTUALLY TREATED BY THE REGISTRANT AS PRIVATE OR CONFIDENTIAL. |
|
| March 22, 2024 |
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) CUSTOMARILY AND ACTUALLY TREATED BY THE REGISTRANT AS PRIVATE OR CONFIDENTIAL. |
|
| March 22, 2024 |
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) CUSTOMARILY AND ACTUALLY TREATED BY THE REGISTRANT AS PRIVATE OR CONFIDENTIAL. |
|
| March 22, 2024 |
DESCRIPTION OF SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 Exhibit 2.3 DESCRIPTION OF SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 The following description of the ordinary shares, the American Depositary Shares and the articles of association, or bylaws, of Valneva SE (“Valneva,” the “Company,” “us” or “we”) is a summary and does not purport to be complete. This summary is subject to, and qualified in its entirety b |
|
| March 22, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 13(d) OF THE SECURITIES EXC |
|
| March 22, 2024 |
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We hereby consent to the incorporation by reference in the Registration Statement on Form F-3 (No. |
|
| March 22, 2024 |
EXHIBIT 13.2 CERTIFICATION BY THE PRINCIPAL FINANCIAL OFFICER PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Peter Bühler, Chi |
|
| March 22, 2024 |
EXHIBIT 12.2 CERTIFICATION PURSUANT TO RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I, Peter Bühler, certify that: 1.I have reviewed this annual report on Form 20-F of Valneva SE (the “Company”); 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to st |
|
| March 22, 2024 |
EdgarFiling EXHIBIT 99.1 Valneva to Present on its Chikungunya Vaccine IXCHIQ®, Participate in Multiple Events at the 24th World Vaccine Congress in Washington D.C. Saint-Herblain (France), March 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced it will present on its single-shot chikungunya vaccine, IXCHIQ®, moderate a roundtable on the Zika a |
|
| March 22, 2024 |
Terms and conditions of the 2023 Employee Stock Option Plan VALNEVA SE Terms and conditions of the 2023 Employee Stock Option Plan Page | 1 1. |
|
| March 22, 2024 |
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We consent to the incorporation by reference in Registration Statement No. |
|
| March 22, 2024 |
EXHIBIT 13.1 CERTIFICATION BY THE PRINCIPAL EXECUTIVE OFFICER PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Thomas Lingelbach |
|
| March 22, 2024 |
Valneva SE (the “Company”) 2022 Special Free Share Plan Number 2 Terms and Conditions Valneva SE (the “Company”) 2022 Special Free Share Plan Number 2 Terms and Conditions 1. |
|
| March 22, 2024 |
EXHIBIT 12.1 CERTIFICATION PURSUANT TO RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I, Thomas Lingelbach, certify that: 1.I have reviewed this annual report on Form 20-F of Valneva SE (the “Company”); 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit |
|
| March 22, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: March 21, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offic |
|
| March 22, 2024 |
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) CUSTOMARILY AND ACTUALLY TREATED BY THE REGISTRANT AS PRIVATE OR CONFIDENTIAL. |
|
| March 22, 2024 |
VALNEVA SE Incentive Compensation Recoupment Policy Adopted by the Board of Directors on December 20, 2023 (in connection with the Company's change of governance on the same date, and as previously adopted by the Company's Supervisory Board) 1. |
|
| March 22, 2024 |
Valneva SE (the “Company”) 2023-2026 Free Share Plan Terms and Conditions Valneva SE (the “Company”) 2023-2026 Free Share Plan Terms and Conditions 1. Background and purpose of the plan On June 21, 2023, the General Meeting of Valneva SE’s shareholders decided under its 28th resolution to grant the Company’s Management Board (“MB”) all powers necessary to decide the granting and issuance of free ordinary shares (“FS”) for the benefit of members of the MB or employees of |
|
| March 22, 2024 |
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) CUSTOMARILY AND ACTUALLY TREATED BY THE REGISTRANT AS PRIVATE OR CONFIDENTIAL. |
|
| March 22, 2024 |
Execution Version [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) CUSTOMARILY AND ACTUALLY TREATED BY THE REGISTRANT AS PRIVATE OR CONFIDENTIAL. |
|
| March 22, 2024 |
Terms and conditions of the 2023 Senior Leadership Group Stock Option Plan VALNEVA SE Terms and conditions of the 2023 Senior Leadership Group Stock Option Plan Page | 1 1. |
|
| March 22, 2024 |
Exhibit 4.12 Certain information has been excluded from this agreement (indicated by “[***]”) because such information (i) is not material and (ii) is the type that the registrant treats as private or confidential. SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30 1. REQUISITION NUMBER 1000166785 PAGE 1 OF 8 2. CONTRACT NO. SPE2DP-23-D-0004 3. AWARD/E |
|
| March 20, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: March 20, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offic |
|
| March 20, 2024 |
Valneva Reports Full Year 2023 Results and Provides Business Updates and Outlook EXHIBIT 99.1 Valneva Reports Full Year 2023 Results and Provides Business Updates and Outlook Total revenues of €153.7 million, including product sales of €144.6 million Product sales surpassed pre-pandemic (2019) sales by 12% and 2022 sales by 26% Excluding COVID-19 vaccine sales, product sales grew by 63% compared to 2022 Cash position of €126.1 million at year-end 2023 enhanced by €95 million f |
|
| March 19, 2024 |
EXHIBIT 99.1 Valneva Announces Extension of the Interest-Only Period of Its Debt Facility with Deerfield and OrbiMed Reimbursements deferred by 18 months to start in January 2026 instead of July 2024 Saint-Herblain (France), March 18, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced an agreement with funds managed by leading U.S. healthcare invest |
|
| March 19, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: March 18, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive offic |
|
| March 4, 2024 |
Valneva to Present at Upcoming TD Cowen and Van Lanschot Kempen Healthcare Investor Conferences EXHIBIT 99.1 Valneva to Present at Upcoming TD Cowen and Van Lanschot Kempen Healthcare Investor Conferences Saint-Herblain (France), March 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will participate at upcoming investor conferences in the United States and Europe. CEO Thomas Lingelbach will present Valneva at t |
|
| March 4, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 Date of Report: March 4, 2024 Commission File Number: 001-40377 Valneva SE (Translation of registrant's name into English) 6 rue Alain Bombard 44800 Saint-Herblain, France (Address of principal executive office |
