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Arcturus Therapeutics Holdings Inc. ARCT announced that the FDA has granted a Fast Track designation to its self-amplifying mRNA (sa-mRNA) vaccine candidate, ARCT-2304, for active immunization to protect against the influenza A H5N1 virus.
The Fast Track designation from the FDA facilitates rapid development and expedites the review of vaccines that are being developed to treat serious conditions and have the potential to address unmet medical needs.
The Fast Track tag is likely to expedite the development path for ARCT-2304 and help in faster regulatory filing for the vaccine in the United States.
ARCT’s Price Performance
Year to date, shares of Arcturus have plunged 44.9% compared with the industry’s decline of 7.9%.
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In November 2024, the FDA cleared the investigational new drug (IND) application to begin clinical studies on the sa-mRNA vaccine candidate, ARCT-2304, for active immunization to prevent pandemic influenza disease caused by the H5N1 virus.
The phase I study in the United States is funded by Biomedical Advanced Research and Development Authority.
ARCT’s sa-mRNA Vaccine for COVID-19
Arcturus developed the first sa-mRNA COVID-19 vaccine, Kostaive. The company has a collaboration agreement with renowned vaccine company CSL Seqirus for making innovative mRNA vaccines.
In November 2023, Japan's Ministry of Health, Labor and Welfare (MHLW) approved Kostaive for initial vaccination and booster for adults aged 18 years and above. The regulatory body in Japan also approved/authorized the updated formulation of the sa-mRNA COVID-19 vaccine, Kostaive, targeting the variant JN.1 in September 2024.
Arcturus launched Kostaive in Japan in the same month. The vaccine is marketed in Japan by Meiji Seika Pharma, which obtained the rights for distribution from CSL Seqirus.
A biologics license application for Kostaive in the United States is expected to be filed later in 2025.
ARCT’s Wholly-Owned mRNA Therapeutic Candidates
Arcturus' wholly-owned mRNA therapeutic candidates include ARCT-032 and ARCT-810, which are being developed to treat cystic fibrosis (CF) and ornithine transcarbamylase (OTC) deficiency, respectively.
Arcturus initiated dosing in a phase II multiple-ascending dose study to evaluate ARCT-032 in people with CF in December 2024. Interim data from the same is expected by the end of the second quarter of 2025.
Arcturus is evaluating ARCT-810 in a phase II multiple-ascending dose study for the treatment of OTC deficiency. Interim data from this study is expected by the end of the second quarter of 2025.