TheTechno Optimist.

No dispatches yet.

KOSTAIVE (sa-mRNA COVID-19 vaccine)

by Arcturus TherapeuticsUS

Provide longer-lasting COVID-19 immunity with lower vaccine dose via self-amplifying mRNA.

DeployStage 4 of 5

Approved Japan (Nov 2023), EU (Feb 2025).

Updated 14 Feb 2025Checked 11 Oct0 updates this week

Milestones

No announced next step

Japan Ministry of Health approvalNov 2023Complete.
Sales begin in JapanOct 2024Complete.
EMA CHMP positive opinion12 Dec 2024Complete.
EU Commission approval14 Feb 2025Complete.

Most important updates

EU approves KOSTAIVE, first self-amplifying mRNA vaccine14 Feb 2025

Current obstacles

Innate immune activationRNA triggers pattern-recognition receptors, potentially limiting transfection.

Physics limits

Immune signal from RNARNA is intrinsic danger signal; high replication can over-activate immunity.

How it works

3 parts

Self-amplifying design

RNA replication in cells

KOSTAIVE contains RNA replication machinery; transfected mRNA replicates inside cells.

Lower vaccine dose

Amplification advantage

Amplification enables smaller initial doses vs. standard mRNA vaccines.

Durable immune response

Extended antigen exposure

Sustained intracellular production generates durable antibody responses.

Spec sheet

Spec	KOSTAIVE (sa-mRNA COVID-19 vaccine)
Antibody persistence	Superior to standard mRNA at 12+ months^R (reported)
Platform	Self-amplifying mRNA^R (reported)

^R reported by the company

Update log

1 update

Fri 14 Feb 2025

Major: EU approves KOSTAIVE, first self-amplifying mRNA vaccinePressRegulatory

About Arcturus Therapeutics

The team behind KOSTAIVE (sa-mRNA COVID-19 vaccine)

Arcturus Therapeutics

Self-amplifying mRNA vaccines, infectious disease

Late-stage clinical mRNA medicines company founded 2013. Develops self-amplifying mRNA vaccines for infectious diseases with CSL Seqirus partnership.

KOSTAIVE is world's first approved self-amplifying mRNA vaccine.
Approved in Japan (Nov 2023), EU (Feb 2025) for COVID-19.
Superior antibody persistence vs. standard mRNA at 12+ months.

arcturusrx.com (opens arcturusrx.com)Company profile →

Founded: 201313 yrs
Headquarters: United States
Status: Public
Listed: ARCT (opens google.com)NASDAQ
Valuation: public
Works in: BiotechRNA medicines
Coverage: 1 program · 1 updatelatest 14 Feb 2025checked 11 Oct
People: Joseph Payne (opens arcturusrx.com)President, CEO