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CSL and Arcturus Therapeutic’s self-amplifying mRNA vaccine shows stronger immune response than conventional mRNA vaccine for up to one year at lower dose.

Arcturus Therapeutics' self-replicating mRNA COVID-19 vaccine, developed with CSL, elicits better immune responses 12 months post-vaccination compared to BioNTech/Pfizer's Comirnaty. Arcturus' self-amplifying technology provides stronger immune responses to SARS-CoV-2. ARCT-154, one of Arcturus' vaccines, has been approved in Japan and is seeking approval in Europe. A Phase III trial showed ARCT-154 boosted neutralizing antibodies more effectively than Comirnaty. Arcturus and CSL are also developing a bivalent version, ARCT-2301, targeting newer virus strains.

Arcturus Therapeutics, with a $533.7M market cap, leverages its LUNAR LNP platform for next-gen vaccines and rare disease treatments. Despite mixed financials (sales from $206M in 2022 to projected $147.9M in 2024, EPS from $0.35 in 2022 to a projected -$4.72 in 2024), strategic partnerships with CSL and Meiji offer potential revenue streams. Arcturus faces competition in the vaccine market but aims to differentiate with superior efficacy and safety profiles enabled by its LUNAR technology.

FDA approves AstraZeneca's FluMist nasal spray flu vaccine for self-administration, the first of its kind. The vaccine, available through a third-party online pharmacy, requires a screening and eligibility assessment. Individuals aged 2-17 should still receive it from a caregiver.

FDA approves AstraZeneca's FluMist nasal spray flu vaccine for self-administration, the first of its kind. The vaccine, initially approved in 2003 for healthcare provider administration, will be available via third-party online pharmacies after a screening and eligibility assessment. Individuals aged 2-17 must still receive the vaccine from a caregiver.

Canaccord Genuity maintains Buy rating on Arcturus Therapeutics, following Japanese approval of Kostaive JN.1. Arcturus to distribute 4-4.5M doses in Oct, generating $85M, though revenue uncertain until 2025. Awaiting EMA decision on Kostaive approval in Q3 2024. Arcturus also advances cystic fibrosis treatment and reports Q2 2024 revenue of $49.9M despite net loss. Financial health and market performance analyzed by InvestingPro, highlighting volatility and negative gross profit margin.

CSL and Arcturus Therapeutics received approval from Japan's MHLW for their updated sa-mRNA Covid-19 vaccine, Kostaive, targeting the JN.1 Omicron subvariants for adults 18 and older. Meiji Seika Pharma will distribute the vaccine in time for the October Covid-19 vaccination campaign, marking the world's first commercially available sa-mRNA Covid-19 vaccine for adults. The approval is based on clinical evidence supporting the vaccine's safety and effectiveness, with data showing superior immunogenicity to Omicron BA 4/5 and duration of immunity up to one year.

CSL and Arcturus Therapeutics' KOSTAIVE®, the first self-amplifying mRNA COVID-19 vaccine, was approved for adults in Japan, targeting the JN.1 Omicron subvariants, with distribution starting in October.