Arcturus Gets FDA Fast-Track Designation for Pandemic Influenza A H5N1 Vaccine

Dow Jones2025-04-10

By Colin Kellaher

Arcturus Therapeutics Holdings has won U.S. Food and Drug Administration fast-track designation for its ARCT-2304 pandemic flu vaccine candidate.

Arcturus on Thursday said the designation recognizes the potential of ARCT-2304, a messenger RNA-based vaccine candidate, to address unmet medical needs for the prevention of disease caused by pandemic influenza A virus H5N1.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Arcturus, a San Diego medicines and vaccines company, in November launched a Phase 1 clinical study, supported in whole with federal funds from the Department of Health and Human Services.

Outbreaks of avian influenza A H5N1, also known as bird flu, have been decimating U.S. poultry flocks since 2022, and while the federal government currently assesses the risk from H5N1 viruses to the general U.S. population as low, it has committed hundreds of millions of dollars to push development of vaccines for a potential pandemic.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

April 10, 2025 08:44 ET (12:44 GMT)

Copyright (c) 2025 Dow Jones & Company, Inc.

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