Valneva

VALN

Market cap $847M

French drugmaker Valneva said on Monday it has voluntarily withdrawn its application seeking standard approval of its chikungunya vaccine in the United States after the FDA suspended the shot's license in August, citing safety concerns.

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.

Registered office: Îlot Saint Joseph Bureaux Convergence – 12T Quai Perrache – 69002 Lyon

Saint-Herblain (France), Pune, (India), December 31, 2025 – Valneva SE (“Valneva” or “the Company”), a specialty vaccine company, and Serum Institute of India (SII), a Cyrus Poonawalla Group company today announced that they have mutually agreed to discontinue their license agreement for Valneva's single-shot chikungunya vaccine.

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.

Registered office: 6 rue Alain Bombard, 44800 Saint-Herblain (France).

Valneva SE (NASDAQ: VALN) shared final immunogenicity and safety data on Wednesday from the Phase 2 study, VLA15-221, of the Lyme disease vaccine candidate, VLA15.

Saint- Herblain  (France),  November   26 ,  202 5  – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced a strategic initiative to optimize its organizational footprint in France  as part of the Company's ongoing efforts to increase operational effectiveness and position Valneva for long-term success.

Valneva said that antibody levels remained well above baseline across all six Lyme disease serotypes and all age groups in the trial.