08:43 AM EDT, 04/10/2025 (MT Newswires) -- Arcturus Therapeutics Holdings ( ARCT ) said Thursday the US Food and Drug Administration granted fast-track designation to its mRNA vaccine candidate ARCT-2304 for pandemic influenza A H5N1.

The company said the vaccine candidate, which uses self-amplifying mRNA technology, began phase 1 testing in November. The designation is intended to speed up the regulatory review process and improve communication with the FDA, according to Arcturus.

ARCT-2304, also called LUNAR-H5N1, is backed by funding from the US Department of Health and Human Services under a contract with the Biomedical Advanced Research and Development Authority.