VALN - FDA grants Breakthrough Therapy status for Valneva's chikungunya vaccine

Valneva ([[VALN]] -2.5%) has been awarded Breakthrough Therapy Designation for its single-shot chikungunya vaccine candidate, VLA1553, by the U.S. FDA.Breakthrough Therapy status intends to facilitate and expedite development and review of certain new drugs for serious or life-threatening conditions.Valneva highlighted that it had completed recruitment for its pivotal late-stage trial, VLA1553-301, in April 2021 and expects to report topline data this summer.The primary objective of the trial is to evaluate the immunogenicity and safety of VLA1553 at 28 days following a single immunization.

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FDA grants Breakthrough Therapy status for Valneva's chikungunya vaccine