VALN - Valneva stock rises as it seeks FDA approval of single-shot chikungunya vaccine

• Valneva ( NASDAQ: VALN ) ( OTCPK:INRLF ) said it completed a rolling submission of an application to the U.S. Food and Drug Administration (FDA) seeking approval of its single-shot chikungunya vaccine VLA1553 in people aged 18 years and above.
• The Biologics License Application (BLA) for VLA1553 is backed by data from a phase 3 study.
• The French company added that a trial of VLA1553 in adolescents is ongoing in Brazil, which may support future regulatory submissions in this group if the vaccine is initially approved in adults.
• Valneva started the rolling submission in August.
• The company noted that it plans to make regulatory submissions for VLA1553 in Europe in H2 2023.
• "Chikungunya is a major public health threat transmitted to humans by infected mosquitoes, and no vaccine or specific treatments for the disease are currently available," said Valneva Chief Medical Officer Juan Jaramillo.
• Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes.
• VALN +8.04% to $14.57 premarket Dec. 23

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