VALN News

Saint Herblain (France), January 19, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Company has decided to voluntarily withdraw the biologics license application (BLA) and Investigational New Drug (IND) application for its chikungunya vaccine, IXCHIQ®, in the United States, following suspension of the license by the U.S. Food and Drug Administration (FDA) in August 2025. The Company had been awaiting further information with respect to its formal response to the vaccine license suspension. Valneva was recently informed of the FDA’s further decision to now place the Investigational New Drug (IND) on clinical hold pending an investigation of a newly reported foreign Serious Adverse Event (SAE).

Saint Herblain (France), January 09, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that members of its management team will meet one-on-one with existing shareholders and hold meetings with other institutional specialist investors during the 44th Annual J.P. Morgan Healthcare Conference, January 12-14, 2026, in San Francisco.

Saint-Herblain (France), December 10, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive final antibody persistence and safety data 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, twelve months after vaccination. Partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the European Union, the trial results continue to support future Phase 3 development in children, which the Company plans to initiate after gathering additional real-world experience in the adolescent population.

Saint-Herblain (France), November 20, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported consolidated financial results for the first nine months of the year, ended September 30, 2025. The condensed consolidated interim financial results are available on the Company’s website (Financial Reports – Valneva).

Saint-Herblain (Frankreich), 20. November 2025 – Valneva SE Nasdaq: VALN; Euronext Paris: VLA), ein Spezialimpfstoffhersteller, hat heute seine konsolidierten Finanzergebnisse für die ersten neun Monate des Jahres zum 30. September 2025 bekannt gegeben. Der verkürzte konsolidierte Zwischenabschluss ist auf der Website des Unternehmens verfügbar (Financial Reports – Valneva).

Saint-Herblain (France), le 20 novembre 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), société spécialisée dans les vaccins, a publié aujourd’hui ses résultats financiers consolidés pour les neuf premiers mois de l’exercice clos au 30 septembre 2025. Les résultats financiers intermédiaires consolidés condensés sont disponibles sur le site internet de la Société (Financial Reports – Valneva).

(NASDAQ:VALN) Saint-Herblain (France), September 3rd, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) announced positive immunogenicity and safety data from the ongoing Phase 2 study of Lyme disease vaccine candidate, VLA15. The strong anamnestic immune response and favorable safety profile following a third booster dose were consistent with those reported after receiving previous annual booster doses1,2 further demonstrating compatibility with the anticipated benefits of a yearly vaccination prior to each Lyme season.

Saint Herblain (France), August 25, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the United States Food and Drug Administration (FDA) has suspended the license for IXCHIQ®, citing four new reports of serious adverse events (SAEs) consistent with chikungunya-like illness. The suspension of the license is effective immediately and requires Valneva to stop shipping and selling of IXCHIQ® in the United States.

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. This announcement adds to the adult marketing authorization already received in Canada1 and complements the adolescent label extension received in Europe in April 20252.

Saint-Herblain (France), August 12, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its condensed consolidated financial results for the first half of the year, ended June 30, 2025, and confirmed its 2025 financial guidance. The half year financial report, including the condensed consolidated interim financial report and the half year management report, is available on the Company’s website (Financial Reports – Valneva).

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®. IXCHIQ® remains indicated in the United States for the prevention of disease caused by the Chikungunya Virus (CHIKV) in individuals 18 years of age and older who are at high risk of exposure to CHIKV.

Valneva reports positive six-month data for Ixchiq in children, supporting a full dose approach ahead of a Phase 3 trial set for early 2026.

FDA and CDC recommend halting Ixchiq vaccine use in adults 60 and older after reports of serious adverse events, including deaths, trigger a new safety assessment.

Valneva's chikungunya vaccine Ixchiq receives Brazil approval, enabling expanded trials and access across Latin America and endemic regions.

Valneva (NASDAQ:VALN) will host a conference call at 09:00 AM ET on May 5, 2022, to discuss Q1 2022 earnings results. How to Attend Valneva (VALN) Conference Call Follow this link to access the live webcast.