Bavarian Nordic Initiates Rolling Submission of Biologics License Application with FDA for its Chikungunya Vaccine Candidate [Yahoo! Finance]
BAVARIAN NORDIC R/I S/ADR (BVNRY)
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Source: Yahoo! Finance
Food and Drug Administration (FDA) for a Biologics License Application (BLA) for the licensure of its CHIKV VLP vaccine candidate for immunization against chikungunya virus infection in individuals 12 years of age and older. Bavarian Nordic will submit additional data over the coming months, aiming to complete the BLA submission before the end of the first half of 2024 to support a potential FDA approval of the vaccine in the first half of 2025. “We are pleased to advance our chikungunya vaccine candidate into the registration phase and look forward to working with the regulators in our efforts to bring this novel product to the market. We have generated robust data in adolescents, adults and older adults, suggesting a strong and durable antibody response against the chikungunya virus and a fast onset of protection, which supports our belief that we can establish our vaccine as the preferred choice in this emerging market,” said Paul Chaplin, President and CEO of Bavarian Nordic.
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