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Arcturus Therapeutics granted fast track designation for ARCT-2304 from FDA

Arcturus Therapeutics (ARCT) announced that the FDA has granted fast track designation for the self-amplifying mRNA vaccine candidate, ARCT-2304, designed for active immunization to protect against disease caused by influenza A H5N1 subtype contained in the vaccine. This designation recognizes the potential of ARCT-2304 as an innovative approach to address unmet medical needs for the prevention of disease caused by pandemic influenza A virus H5N1, a significant global health risk. The Phase 1 clinical study initiated in November 2024.

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