Drugs / ARCT-154
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | COVID-19 | 2023-09-05 | “announced today that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for ARCT-154” csl.com ↗ “the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for ARCT-154” arcturusrx.com ↗ |
| Filed | Japan (PMDA) | — | COVID-19 | 2023-08-07 | “A New Drug Application (NDA) for ARCT-154 was submitted in April by Meiji Seika Pharma to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).” arcturusrx.com ↗ “Meiji Seika Pharma submitted ARCT-154 New Drug Application in Japan” arcturusrx.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05037097 | Aug 2021 → Dec 2023 | COVID-19 | Arcturus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT05012943 | Aug 2021 → Jan 2023 | — | Vinbiocare Biotechnology Joint Stock Company | Completed | Met primary |
News releases announcing trial results or a regulatory action · 30
| Date | Issuer | Release |
|---|---|---|
| 2025-02-14 | CSL Behring | Regulatory European Commission Approves CSL and Arcturus Therapeutics' KOSTAIVE®, the First Self-amplifying mRNA COVID-19 Vaccine csl.com ↗
CSL (ASX: CSL; USOTC: CSLLY) and sa-mRNA pioneer Arcturus Therapeutics (Nasdaq: ARCT) today announced that the European Commission has granted marketing authorization for KOSTAIVE ® (ARCT-154), a self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older. |
| 2025-02-14 | Arcturus Therapeutics, Inc. | Regulatory European Commission Approves CSL and Arcturus Therapeutics’ KOSTAIVE®, the First Self-amplifying mRNA COVID-19 Vaccine arcturusrx.com ↗
Global biotechnology leader CSL (ASX: CSL; USOTC: CSLLY) and sa-mRNA pioneer Arcturus Therapeutics (Nasdaq: ARCT) today announced that the European Commission has granted marketing authorization for KOSTAIVE ® (ARCT-154), a self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older. |
| 2024-09-30 | CSL Behring | Results Self-Amplifying mRNA COVID-19 Vaccine Demonstrates Superior Immune Response Compared with mRNA Vaccine at 12 Months Post-Vaccination csl.com ↗
Head-to-head data, presented at OPTIONS XII for the Control of Influenza Conference, demonstrates advantage of sa-mRNA over conventional mRNA in duration of immune response; |
| 2024-09-30 | Arcturus Therapeutics, Inc. | Results Self-Amplifying mRNA COVID-19 Vaccine Demonstrates Superior Immune Response Compared with mRNA Vaccine at 12 Months Post-Vaccination arcturusrx.com ↗ |
| 2024-05-20 | CSL Behring | Results Nature Communications Publishes Pivotal Data Demonstrating Efficacy and Tolerability of CSL and Arcturus Therapeutics' COVID-19 Vaccine csl.com ↗
The results demonstrate that two 5 μg doses of ARCT-154, sa-mRNA vaccine, were well-tolerated, immunogenic and provided significant protection against multiple strains of COVID-19. |
| 2024-05-20 | Arcturus Therapeutics, Inc. | Results Nature Communications Publishes Pivotal Data Demonstrating Efficacy and Tolerability of CSL and Arcturus Therapeutics’ COVID-19 Vaccine arcturusrx.com ↗
The results demonstrate that two 5 μg doses of ARCT-154, sa-mRNA vaccine, were well-tolerated, immunogenic and provided significant protection against multiple strains of COVID-19. |
| 2024-02-05 | CSL Behring | Results New COVID-19 sa-mRNA Results from CSL and Arcturus Therapeutics Demonstrate Longer Duration of Immunity Compared to Conventional COVID-19 mRNA Vaccine Booster csl.com ↗
The new analysis at 6 months post-vaccination shows that ARCT-154 induces a longer immune response as compared to Comirnaty for both the original Wuhan strain and Omicron BA.4/5 variant and an advantage in antibody persistence. |
| 2024-02-05 | Arcturus Therapeutics, Inc. | Results New COVID-19 sa-mRNA Results from CSL and Arcturus Therapeutics Demonstrate Longer Duration of Immunity Compared to Conventional COVID-19 mRNA Vaccine Booster arcturusrx.com ↗
The new analysis at 6 months post-vaccination shows that ARCT-154 induces a longer immune response as compared to Comirnaty for both the original Wuhan strain and Omicron BA.4/5 variant and an advantage in antibody persistence. |
| 2023-12-21 | CSL Behring | Results CSL and Arcturus Therapeutics' ARCT-154 Demonstrates Non-Inferiority to Original Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster csl.com ↗
Both vaccines were well-tolerated, with no causally associated severe or serious adverse events. |
| 2023-12-21 | Arcturus Therapeutics, Inc. | Results CSL and Arcturus Therapeutics’ ARCT-154 Demonstrates Non-Inferiority to Original Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster arcturusrx.com ↗
ARCT-154 results were achieved with one sixth the dose of Comirnaty ® (5 μg vs 30 μg). |
| 2023-11-28 | CSL Behring | Regulatory Japan's Ministry of Health, Labour and Welfare Approves CSL and Arcturus Therapeutics' ARCT-154, the first Self-Amplifying mRNA vaccine approved for COVID in adults csl.com ↗ |
| 2023-11-28 | Arcturus Therapeutics, Inc. | Regulatory Japan's Ministry of Health, Labour and Welfare Approves CSL and Arcturus Therapeutics’ ARCT-154, the First Self-Amplifying mRNA Vaccine Approved for COVID in Adults arcturusrx.com ↗ |
| 2023-09-19 | Arcturus Therapeutics, Inc. | Results Study Shows Novel sa-mRNA Vaccines Offer Robust, Broad, Enduring Protection Against COVID-19 Variants arcturusrx.com ↗
Current mRNA technologies provide effective initial immunogenicity against COVID-19, but the results of this study show that our sa-mRNA vaccine platform can offer improvements in duration and breadth of protection against new and emerging variants, |
| 2023-09-05 | CSL Behring | Regulatory Arcturus Therapeutics and CSL Announce European Medicines Agency Validates Marketing Authorization Application for ARCT-154 Vaccine to Prevent COVID-19 csl.com ↗
the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for ARCT-154 |
| 2023-09-05 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics and CSL Announce European Medicines Agency Validates Marketing Authorization Application for ARCT-154 Vaccine to Prevent COVID-19 arcturusrx.com ↗ |
| 2023-08-07 | Arcturus Therapeutics, Inc. | Results Arcturus Therapeutics Announces Second Quarter 2023 Financial Update and Pipeline Progress arcturusrx.com ↗
ARCT-154 Phase 3 COVID-19 booster trial achieved primary endpoint demonstrating strong immune response and favorable safety profile |
| 2023-05-09 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Announces First Quarter 2023 Financial Update and Pipeline Progress arcturusrx.com ↗
New Drug Application (NDA) for ARCT-154, a next generation COVID-19 vaccine, was submitted in Japan , leading to potential approval in 2023 |
| 2022-08-18 | Arcturus Therapeutics, Inc. | Results Arcturus Reports Durability Data Against Omicron Variants, Including BA.5, at Six-Month Timepoint Following Booster with ARCT-154 COVID-19 Vaccine arcturusrx.com ↗
The new results demonstrate broad neutralizing antibody response against Omicron variants of concern, including BA.5, lasting for up to at least six months after administration of low-dose (5 mcg) ARCT-154 booster. |
| 2022-08-09 | Arcturus Therapeutics, Inc. | Results Arcturus Therapeutics Announces Second Quarter 2022 Financial Update and Pipeline Progress arcturusrx.com ↗
Additional data from our Phase 1/2 booster study demonstrates that ARCT-154 provides sustained neutralizing antibodies against Omicron variants BA.1/BA.2 three months after booster vaccination. |
| 2022-05-09 | Arcturus Therapeutics, Inc. | Results Arcturus Therapeutics Announces First Quarter 2022 Financial Update and Pipeline Progress arcturusrx.com ↗
In addition, ARCT-154 has shown promising booster data against all SARS-CoV-2 variants tested, including Omicron BA.1 and BA.2. |
| 2022-05-05 | Arcturus Therapeutics, Inc. | Results Arcturus Reports Strong Three-Month Durability Results from ARCT-154 Booster Trial arcturusrx.com ↗
today provided updated data from its Phase 1/2 booster clinical trial showing durability of antibody response with ARCT-154 for at least three months after low-dose (5 mcg) booster. |
| 2022-04-20 | Arcturus Therapeutics, Inc. | Results Arcturus Announces Self-amplifying COVID-19 mRNA Vaccine Candidate ARCT-154 Meets Primary Efficacy Endpoint in Phase 3 Study arcturusrx.com ↗
We are very pleased with these results, and to see ARCT-154 providing protection against symptomatic COVID-19 and almost complete protection against severe disease in a placebo-controlled vaccine efficacy study. |
| 2022-02-28 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Announces Fourth Quarter and Full Year 2021 Financial Update and Pipeline Progress arcturusrx.com ↗ |
| 2022-01-25 | Arcturus Therapeutics, Inc. | Results Arcturus Therapeutics Reports New Data Demonstrating Neutralizing Antibody Immune Response to the SARS-CoV-2 Omicron Variant from ARCT-154 and ARCT-165 Booster Clinical Trial arcturusrx.com ↗
Analysis of sera from Phase 1/2 booster study demonstrates 54- and 47-fold increases in geometric mean neutralizing antibody titers against the Omicron variant at Day 29 for ARCT-154 (5 mcg) and ARCT-165 (5 mcg) respectively |
| 2022-01-24 | Arcturus Therapeutics, Inc. | Results Arcturus Therapeutics Updates Data from ARCT-154 and ARCT-165 Booster Clinical Trial Demonstrating Robust Neutralizing Antibody Responses to SARS-CoV-2 and Several Variants arcturusrx.com ↗ |
| 2021-12-16 | Arcturus Therapeutics, Inc. | Results Arcturus Therapeutics Reports New Data and Provides Additional Updates from ARCT-154 and ARCT-165 Clinical Trials arcturusrx.com ↗
Additional data shows activity against several variants of concern and variants of interest upon boosting with ARCT-154 (5 mcg) and ARCT-165 (5 mcg) in a surrogate virus neutralization (sVNT) assay |
| 2021-10-12 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Announces Approval from Vietnam Ministry of Health to Proceed into Phase 3b Study for ARCT-154, a Next Generation STARR™ mRNA Vaccine Targeting SARS-CoV-2 Delta Variant and Other Variants of Concern arcturusrx.com ↗
Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a leading clinical-stage messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, today announced that the Vietnam Ministry of Health has approved initiation of the Phase 3b part of the placebo-controlled, observer-blind Phase 1/2/3 clinical trial of ARCT-154 self-replicating RNA vaccine targeting the SARS-CoV-2 delta variant and other variants of concern. |
| 2021-09-22 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Announces Approval from Vietnam Ministry of Health to Proceed into Phase 2 and Phase 3a for ARCT-154, Next Generation STARR™ mRNA Vaccine Targeting SARS-CoV-2 Delta Variant and Other Variants of Concern arcturusrx.com ↗
The Vietnam Ministry of Health has reviewed the safety data following both injections in the Phase 1 part of the study and has given permission to proceed with enrollment of Phase 2 and Phase 3a. |
| 2021-08-03 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Announces Approval of Singapore Clinical Trial Application to Advance ARCT-154 and ARCT-165, Next Generation STARR™ mRNA Vaccines Targeting SARS-CoV-2 Variants of Concern, in a Phase 1/2 Study arcturusrx.com ↗ |
| 2021-08-02 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Announces Approval of a Clinical Trial Application to Advance ARCT-154, a Next Generation STARR™ mRNA Vaccine Targeting the SARS-CoV-2 Delta Variant and Other Variants of Concern arcturusrx.com ↗ |
All press releases naming this drug 30 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ARCT-154 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05012943 ↗ |
| Modality | Small activating RNA (saRNA) | “ARCT-154 Self-Amplifying RNA Vaccine” NCT05012943 ↗ |