मूलभूत आँकड़े
CIK | 1836564 |
SEC Filings
SEC Filings (Chronological Order)
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. |
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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 |
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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. |
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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 |
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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. |
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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 |
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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 |
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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. |
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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 |
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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®. |
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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 |
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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). |
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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. |
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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 |
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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 |
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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. |
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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 |
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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) |
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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. |
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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) |
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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 |
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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) |
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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) |
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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. |
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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. |
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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) |
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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. |
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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. |
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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 |
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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 |
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April 18, 2025 |
Valneva Provides Update on ACIP Recommendation for its Chikungunya Vaccine IXCHIQ® Among U. |
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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 |
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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. |
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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. |
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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 |
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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 |
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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. |
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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 |
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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). |
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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. |
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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 |
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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 |
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March 25, 2025 |
As filed with the Securities and Exchange Commission on March 24, 2025 Registration No. |
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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 |
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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 |
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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. |
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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. |
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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. |
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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. |
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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. |
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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 |
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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 |
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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. |
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March 24, 2025 |
VALNEVA SE European company with a Board of Directors with a share capital of 24,378,228. |
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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®. |
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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 |
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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 |
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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. |
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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. |
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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. |
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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 |
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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 |
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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 |
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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. |
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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 |
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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. |
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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 |
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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. |
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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. |
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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 |
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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 |
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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. |
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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 |
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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. |
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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®. |
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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 |
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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 |
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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, |
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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 |
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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. |
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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. |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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. |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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. |
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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. |
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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 |
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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 |
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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 |
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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. |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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) |
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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 |
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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 |
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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 |
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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 |
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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 |
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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) |
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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. |
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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) |
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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 |
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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) |
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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 |
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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 |
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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) |
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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) |
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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 |
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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 |
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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) |
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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. |
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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) |
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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 |
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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 |
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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 |
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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. |
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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 |
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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. |
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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. |
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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. |
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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 |
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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. |
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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. |
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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 |
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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 |
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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. |
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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. |
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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 |
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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. |
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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 |
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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. |
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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. |
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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 |
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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 |
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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 |
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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. |
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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 |
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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. |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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February 29, 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: February 29, 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 |
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February 29, 2024 |
EXHIBIT 99.1 U.S. CDC Advisory Committee (ACIP) Recommends Use of Valneva’s Single-Dose Chikungunya Vaccine IXCHIQ® Recommendation for use in travelers and laboratory workers follows U.S. Food and Drug Administration (FDA) approval in November 20231 IXCHIQ® is the first and only vaccine approved to address this unmet medical need in adults aged 18 years and older who are at increased risk of expos |
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February 15, 2024 |
EXHIBIT 99.1 Valneva Reports Full Year 2023 Revenue and Cash, Provides First 2024 Guidance Valneva Reports Full Year 2023 Revenue and Cash, Provides First 2024 Guidance 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 |
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February 15, 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: February 15, 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 |
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February 14, 2024 |
FR:VALN / Valneva SE / Deep Track Capital, LP Passive Investment SC 13G/A 1 deeptrack-valn123123a1.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 1)* 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) December 31, 2023 |
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February 5, 2024 |
Valneva Announces Sale of Priority Review Voucher for $103 Million EXHIBIT 99.1 Valneva Announces Sale of Priority Review Voucher for $103 Million Saint-Herblain (France), February 5, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced it sold the Priority Review Voucher (PRV) it received from the U.S. Food and Drug Administration (FDA) for $103 million (€95 million). The Company was awarded a tropical disease PRV i |
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February 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: February 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 off |
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January 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: January 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 |
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January 10, 2024 |
Valneva Vaccinates First Participant in Pediatric Trial of Single-Shot Chikungunya Vaccine EXHIBIT 99.1 Valneva Vaccinates First Participant in Pediatric Trial of Single-Shot Chikungunya Vaccine Saint-Herblain (France), January 10, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that the first participant has been vaccinated in the Phase 2 clinical trial evaluating the safety and Immunogenicity in children of two different dose levels of Valneva’s single-shot chiku |
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January 8, 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: January 08, 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 |
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January 8, 2024 |
Valneva to Conduct Investor Meetings during the J.P. Morgan Healthcare Conference and Oddo BHF Forum EdgarFiling EXHIBIT 99.1 Valneva to Conduct Investor Meetings during the J.P. Morgan Healthcare Conference and Oddo BHF Forum Saint-Herblain (France), January 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that members of its management team including Thomas Lingelbach, CEO and Peter Bühler, CFO will hold investor meetings during the 42nd Ann |
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December 29, 2023 |
Valneva Provides Updated 2023 Financial Guidance EXHIBIT 99.1 Valneva Provides Updated 2023 Financial Guidance Saint-Herblain (France), December 29, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Company is modifying its financial guidance for 2023. Product sales guidance remains unchanged, as do anticipated R&D expenses. The €90 million to €110 million of other income related to proc |
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December 29, 2023 |
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 29, 2023 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 |
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December 21, 2023 |
EXHIBIT 99.1 Valneva Shareholders Approve EGM Resolutions Including the Transition to a Board of Directors Anne-Marie Graffin is appointed as Chair of the Board of Directors Saint-Herblain (France), December 20, 2023 –Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its shareholders approved the resolutions recommended by the Management Board at its |
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December 21, 2023 |
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 21, 2023 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 |
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December 5, 2023 |
EXHIBIT 99.1 Valneva Reports Positive 24-Month Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ® Primary endpoint met with 97% seroresponse rate 24 months after a single vaccination Antibody levels remained high and well above the seroresponse threshold, further supporting the anticipated long-term durability of the immune response No safety concerns identified in long-term |
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December 5, 2023 |
EXHIBIT 99.2 Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15 9,437* participants enrolled at sites across the U.S., Europe and Canada in areas where Lyme disease is endemic Trial conclusion expected by year-end 2025 Pfizer aims to submit regulatory filings in the U.S. and Europe in 2026 New York, NY, and Saint-Herblain (France), December 4, |
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December 5, 2023 |
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 5, 2023 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 |
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November 27, 2023 |
EXHIBIT 99.1 EMA Accepts Valneva’s Chikungunya Vaccine Marketing Authorization Application for Accelerated Assessment Saint-Herblain (France), November 27, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) has performed a technical validation of the Marketing Authorization Application (MAA) for Valneva’s sin |
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November 27, 2023 |
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 27, 2023 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 |
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November 15, 2023 |
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 15, 2023 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 |
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November 15, 2023 |
EdgarFiling EXHIBIT 99.1 Valneva Announces the Availability of Documentation for its Extraordinary General Meeting including Planned Changes to its Future Board of Directors Saint-Herblain (France), November 15, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the availability of documentation for its Extraordinary General Meeting (“General Meetin |
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November 13, 2023 |
Valneva Announces U.S. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ® EdgarFiling EXHIBIT 99.1 Valneva Announces U.S. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ® Saint-Herblain (France), November 10, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Administration (FDA) has approved IXCHIQ®, Valneva’s single-dose, live-attenuated vaccine indicated for the prevention of disea |
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November 13, 2023 |
EdgarFiling EXHIBIT 99.2 Valneva Reports Positive Pivotal Phase 3 Immunogenicity Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate Saint-Herblain (France), November 13, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive pivotal Phase 3 immunogenicity data in adolescents for its single-dose chikungunya virus (CHIKV) vaccin |
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November 13, 2023 |
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, 2023 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 |
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November 9, 2023 |
Valneva Reports Nine-Month 2023 Financial Results and Provides Corporate Updates VALNEVA SE Campus Bio-Ouest | 6, Rue Alain Bombard 44800 Saint-Herblain, France Valneva Reports Nine-Month 2023 Financial Results and Provides Corporate Updates Product sales of €106. |
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November 9, 2023 |
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 9, 2023 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 |
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November 9, 2023 |
VALNEVA SE - NINE-MONTH 2023 FINANCIAL STATEMENTS 2 UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS AT SEPTEMBER 30, 2023 1 UNAUDITED INTERIM CONSOLIDATED STATEMENTS OF INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) 1. |
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November 7, 2023 |
Valneva to Present and Hold Investor Meetings at the Jefferies London Healthcare Conference EXHIBIT 99.1 Valneva to Present and Hold Investor Meetings at the Jefferies London Healthcare Conference Saint-Herblain (France), November 7, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and participate in 1-on-1 meetings with institutional investors at the Jefferies London Healthcare Conference, to take |
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November 7, 2023 |
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, 2023 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 |
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October 27, 2023 |
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 27, 2023 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 |
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October 27, 2023 |
EXHIBIT 99.1 Valneva Submits Chikungunya Vaccine Marketing Application to EMA and Announces CHMP Accelerated Assessment Saint-Herblain (France), October 25, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the submission of a marketing application with the European Medicines Agency (EMA) for approval of the Company’s single-shot chikungunya vaccin |
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October 13, 2023 |
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 13, 2023 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 |
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October 13, 2023 |
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 11, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today it will present on the mosquito-borne chikungunya disease at several leading scientific conferences during the fourth quarter of 2023. At IDWeek, the annual meeting of the In |
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September 26, 2023 |
EXHIBIT 99.1 Valneva Announces New IXIARO® Supply Contract with the U.S. Government Worth a Minimum of $32 Million Saint Herblain (France), September 25, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the signing of a new $32 million contract with the United States (U.S.) Department of Defense (DoD) for the supply of its Japanese encephalitis (J |
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September 26, 2023 |
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 26, 2023 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 |
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September 21, 2023 |
Thomas Lingelbach President and Chief Executive Officer VALNEVA SE - 2023 HALF-YEAR FINANCIAL REPORT 2 TABLE OF CONTENTS GENERAL INTRODUCTORY COMMENTS AND DISCLAIMER 3 I. |
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September 21, 2023 |
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 21, 2023 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 |
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September 21, 2023 |
Valneva Reports Half Year 2023 Financial Results and Provides Corporate Updates VALNEVA SE Campus Bio-Ouest | 6, Rue Alain Bombard 44800 Saint-Herblain, France Valneva Reports Half Year 2023 Financial Results and Provides Corporate Updates Product sales more than doubled in the first half of 2023 to €69. |
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September 7, 2023 |
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 7, 2023 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 |
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September 7, 2023 |
EdgarFiling EXHIBIT 99.1 Valneva and Pfizer Report Positive Pediatric and Adolescent Phase 2 Booster Results for Lyme Disease Vaccine Candidate Strong immune response shown in both children and adolescents one month after booster dose (month 19) in VLA15-221 study Previously observed high anamnestic antibody response in adults confirmed VLA15 well-tolerated in all age groups following booster dose |
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September 1, 2023 |
Valneva to Participate in Investor Conferences in the United States and Europe in September 2023 EXHIBIT 99.1 Valneva to Participate in Investor Conferences in the United States and Europe in September 2023 Saint-Herblain (France), August 31, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that members of its senior leadership team are scheduled to participate in 1-on-1 meetings with institutional investors at the following investor conferen |
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September 1, 2023 |
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 1, 2023 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 |
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August 29, 2023 |
EdgarFiling EXHIBIT 99.1 Valneva Reports Positive Initial Phase 3 Safety Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate Saint-Herblain (France), August 28, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive initial Phase 3 safety data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA155 |
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August 29, 2023 |
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 29, 2023 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 |
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August 29, 2023 |
Health Canada Accepts Valneva’s Chikungunya Vaccine License Application for Review EXHIBIT 99.2 Health Canada Accepts Valneva’s Chikungunya Vaccine License Application for Review Saint-Herblain (France), August 29, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that Health Canada has completed screening validation of the Company’s regulatory application for marketing approval of its single-shot chikungunya vaccine candidate VL |
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August 17, 2023 |
EdgarFiling EXHIBIT 99.1 Valneva Announces Extension of Existing Loan Agreement Up to an additional $100 million made available in two tranches Saint-Herblain (France), August 17, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced an agreement to increase the principal amount of its existing $100 million senior secured debt financing agreement with |
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August 17, 2023 |
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 17, 2023 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 |
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August 14, 2023 |
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 14, 2023 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 |
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August 14, 2023 |
Valneva Announces PDUFA Date Extension for Chikungunya Virus Vaccine Candidate EXHIBIT 99.1 Valneva Announces PDUFA Date Extension for Chikungunya Virus Vaccine Candidate Saint-Herblain (France), August 14, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Administration (FDA) has revised the Prescription Drug User Fee Act (PDUFA) action date for the Biologics License Application (BLA) for VLA1553, |
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August 11, 2023 |
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 |
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August 11, 2023 |
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 |
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August 11, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F/A (Amendment No. 1) (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, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 13(d) O |
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August 10, 2023 |
Katie Kazem +1 703 456-8043 [email protected] VIA EDGAR August 10, 2023 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Eric Atallah Lyn Dicker Re: Valneva SE Form 20-F for the fiscal year ended December 31, 2022 Filed March 30, 2023 File number 001-40377 Ladies and Gentlemen: This letter is submitted on behalf of Valneva SE ( |
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June 30, 2023 |
FR:VALN / Valneva SE / Bpifrance Participations SA - SC 13D/A Activist Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 1 )* 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 |
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June 30, 2023 |
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 |
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June 22, 2023 |
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 22, 2023 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 |
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June 22, 2023 |
EXHIBIT 99.1 Valneva Announces Successful Outcome of its AGM and the Appointment of Pfizer’s Former Vaccine R&D Head to its Supervisory Board Saint-Herblain (France), June 21, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Management Board were approved by the shareholders at its Annual General Meeting |
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June 22, 2023 |
EXHIBIT 99.2 Valneva Supervisory Board Recommends Transition from a Two-Tier Governance Model to a Board of Directors Saint-Herblain (France), June 22, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its Supervisory Board has recommended a change of governance model. The Company’s Supervisory Board members voted in favor of recommending to t |
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June 14, 2023 |
Valneva Announces Publication of its Chikungunya Vaccine Candidate Phase 3 Data in The Lancet EdgarFiling EXHIBIT 99.1 Valneva Announces Publication of its Chikungunya Vaccine Candidate Phase 3 Data in The Lancet Saint-Herblain (France), June 13, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that the Company’s pivotal Phase 3 data for its single-shot chikungunya vaccine candidate, VLA1553, have been published in The Lancet , the world’s |
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June 14, 2023 |
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 14, 2023 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 |
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May 31, 2023 |
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, 2023 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) |
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May 31, 2023 |
Valneva to Present and Hold Investor Meetings at Upcoming Conferences in June EdgarFiling EXHIBIT 99.3 Valneva to Present and Hold Investor Meetings at Upcoming Conferences in June Saint-Herblain (France), May 31, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will attend the Jefferies Healthcare Conference (June 7-9 in New York), Goldman Sachs Annual Global Healthcare Conference (June 12-15 in |
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May 31, 2023 |
Valneva Announces the Availability of Documentation for its Shareholder Meeting EdgarFiling EXHIBIT 99.2 Valneva Announces the Availability of Documentation for its Shareholder Meeting Saint-Herblain (France), May 31, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the availability of documentation for its Combined General Meeting to be held on June 21, 2023 at 2 p.m. CEST, at the hotel InterContinental Lyon – Hotel Dieu, 20 |
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May 31, 2023 |
Valneva Files for Chikungunya Vaccine Authorization with Health Canada EdgarFiling EXHIBIT 99.1 Valneva Files for Chikungunya Vaccine Authorization with Health Canada Saint-Herblain (France), May 30, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the filing of a regulatory application with Health Canada for marketing approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553, in persons aged 18 ye |
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May 4, 2023 |
Press release dated May 4, 2023 VALNEVA SE Campus Bio-Ouest | 6, Rue Alain Bombard 44800 Saint-Herblain, France Valneva Reports First Quarter 2023 Financial Results and Provides Corporate Updates Product sales increased 98. |
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May 4, 2023 |
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 4, 2023 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) |
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March 31, 2023 |
Valneva Announces Filing of 2022 Universal Registration Document and US Form 20-F EXHIBIT 99.2 Valneva Announces Filing of 2022 Universal Registration Document and US Form 20-F Saint-Herblain (France), March 31, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today the filing, on March 30 2023, of its 2022 Universal Registration Document (URD) with the French Financial Markets Authority (AMF) under the filing number D.23-0199 and it |
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March 31, 2023 |
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, 2023 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 |
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March 31, 2023 |
EdgarFiling EXHIBIT 99.1 Valneva to Present on its Chikungunya Vaccine Candidate and Host a Roundtable at the 23rd World Vaccine Congress in Washington D.C. Saint Herblain (France), March 30, 2023 –Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today it will present on its single-shot chikungunya vaccine candidate, VLA1553, and host a roundtable on Zika vacc |
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March 30, 2023 |
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 |
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March 30, 2023 |
) of the Registrant (English translation) This document is a free translation. In case of discrepancy between the French and the English version, the French version shall prevail. VALNEVA SE European company with an Management Board and Supervisory Board with a share capital of 20,752,045.20 Euros Registered office: 6 rue Alain Bombard, 44800 Saint-Herblain Identification N° 422 497 560 RCS Nantes - ARTICLES OF ASSOCIATION As amended by t |
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March 30, 2023 |
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 |
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March 30, 2023 |
Special Free Ordinary Share Plan 2022-2025 N°2 VALNEVA SE Terms and conditions of the 2022 Senior Leadership Group Stock Option Plan Page | 1 1. |
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March 30, 2023 |
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 |