Approval underscores CSL and Arcturus Therapeutics’ commitment to delivering disruptive technologies to combat COVID-19 and other respiratory viral diseases to protect public health KOSTAIVE ® , the world’s first self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, was approved for adults 18 years of age and older in November 2023 The updated sa-mRNA COVID-19 vaccine is tailored to protect against the JN.1 lineage of Omicron... Read More

SAN DIEGO / Sep 03, 2024 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global messenger RNA medicines company focused on the development of infectious disease vaccines and addressing unmet medical needs within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has issued a “Study May Proceed” notification for the Company’s... Read More

SAN DIEGO / Aug 27, 2024 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global messenger RNA medicines company focused on the development of infectious disease vaccines and addressing unmet medical needs within liver and respiratory rare diseases, today announced that the Company will participate in the following investor and scientific conferences: Wells Fargo 2024... Read More

IND submitted for Phase 2 trial of ARCT-032 targeting cystic fibrosis (CF) ARCT-810 (OTC deficiency) Phase 2 interim data on track for Q4 Kostaive® on track for Q4 commercial launch in Japan Investor conference call at 4:30 p.m. ET today SAN DIEGO / Aug 05, 2024 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global messenger RNA medicines company focused on the development... Read More

SAN DIEGO / Aug 01, 2024 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global messenger RNA medicines company focused on the development of infectious disease vaccines and medicines to treat unmet medical needs within liver and respiratory rare diseases, today announced that the Company will present at Canaccord Genuity 44th Annual Growth Conference in Boston, on Tuesday,... Read More

SAN DIEGO / Jul 18, 2024 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global messenger RNA medicines company focused on the development of infectious disease vaccines and medicines to treat unmet medical needs within liver and respiratory rare diseases, today announced that it will release its financial results for the quarter ended June 30, 2024 after the market close on... Read More

ARCT-810 Phase 2 study completed enrollment at 0.3 mg/kg dose level in Europe with data expected later this year ARCT-810 to expand Phase 2 clinical program in the U.S. to enroll patients with more severe disease ARCT-032 IND for Phase 2 multiple ascending dose study to be submitted in the next 60 days SAN DIEGO / Jul 01, 2024 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a... Read More

Previously Chief Scientific Advisor for Operation Warp Speed, advised U.S. President's Council of Advisors on Science and Technology, member of Advisory Committee to the Director of the NIH SAN DIEGO / Jun 20, 2024 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global messenger RNA medicines company focused on the development of infectious disease vaccines and medicines to... Read More

ARCT-032 is safe and well tolerated with no serious adverse events (SAEs) in 36 study participants, including 4 adults with cystic fibrosis (CF) Phase 1b interim data includes a CF participant with Class 1 mutations and three participants with F508del mutations being treated with Trikafta® Early trend of improved lung function with an average absolute response of +4.0% (ranging up to +9%) and relative change of +5.8% FEV1 on... Read More

Arcturus to present new Phase 1b interim data for ARCT-032 at European Cystic Fibrosis Conference on June 7, 2024 First four CF patients demonstrated an average improvement of 4% FEV1 after two administrations SAN DIEGO / May 28, 2024 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of... Read More

Data follow the approval of the world's first self-amplifying (sa-mRNA) COVID-19 vaccine for adults in Japan. These results add to recently published data on ARCT-154 demonstrating superior immunogenicity to Omicron BA 4/5 compared to conventional mRNA COVID-19 vaccine booster and follow-up data demonstrating longer duration of immunity compared to traditional COVID-19 mRNA vaccine booster. KING OF PRUSSIA, Pa. and SAN DIEGO... Read More

SAN DIEGO / May 15, 2024 / Business Wire / Arcturus Therapeutics Holdings Inc . (the “Company”, “Arcturus”, Nasdaq: ARCT), a global messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the Company will participate in the following investor and scientific conferences: TIDES USA: Oligonucleotide and Peptide... Read More

Commercial manufacture of Kostaive ® on track for delivery of initial 4 million doses in Q3 Kostaive ® European Marketing Authorization Application approval decision expected Q3 Multiple Kostaive ® Phase 3 trials further demonstrate breadth and durability of STARR ® vaccine platform ARCT-2138 (LUNAR-FLU) Phase 1 topline immunogenicity and safety data, anticipated in Q3 ARCT-810 (LUNAR-OTC) Phase 2 and ARCT-032 (LUNAR-CF)... Read More

SAN DIEGO / Apr 25, 2024 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that it will release its financial results for the quarter ended March 31, 2024 after the market close on Wednesday, May 8 and... Read More

Kostaive® anticipated to launch in Japan this year ARCT-032 remains on track for Phase 1b interim data in Q2 ARCT-810 remains on track for Phase 2 interim data by the end of Q2 ARCT-2138 (Quadrivalent LUNAR-FLU) Phase 1 study for seasonal influenza vaccine initiated New STARR® vaccine discovery programs initiated for Lyme Disease and Gonorrhea Cash runway extended to Q1 2027 Investor conference call at 4:30 p.m. ET today SAN... Read More

SAN DIEGO / Feb 26, 2024 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the Company will present at a Fireside Chat hosted by Barclays 26 th Annual Global Healthcare Conference... Read More

Access to protocol assistance, centralized authorization process, fee reductions and 10 years of market exclusivity SAN DIEGO / Feb 22, 2024 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and medicines to treat unmet medical needs within liver and respiratory... Read More

SAN DIEGO / Feb 20, 2024 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, today announced that it will release its financial results for the quarter and year ended December 31, 2023 after... Read More

Study conducted by Meiji Seika Pharma in Japan Short communication follows previously published data in The Lancet Infectious Diseases demonstrating Immunological Non-Inferiority to Wuhan Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster New data demonstrates continuous advantage of sa-mRNA over conventional mRNA vaccine in terms of duration of immune response... Read More

Study conducted by Meiji Seika Pharma in Japan Data follow approval of the world's first self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine for adults by Japan Ministry of Health, Labor and Welfare The randomized, double-blind, active-controlled study, conducted at 11 sites in Japan , was designed to compare the immunogenicity and tolerability of the sa-mRNA vaccine ARCT-154 with Comirnaty ® Phase 3 Study published in... Read More

SAN DIEGO / Dec 04, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, today announced that Joseph Payne, President & Chief Executive Officer, will present at the 42 nd Annual J.P.... Read More

Exclusive Partner in Japan , Meiji Seika Pharma advances regulatory approval This historic approval of the world's first Self-Amplifying messenger RNA (sa-mRNA) COVID-19 Vaccine underscores CSL's promise to develop and deliver innovations when there is a public health need First marketing approval milestone for CSL and Arcturus Therapeutics since closing the Global Collaboration and Licensing agreement in 2022 With the... Read More

First cystic fibrosis patient in Phase 1b study successfully completed two administrations of ARCT-032 On track to share interim Phase 1b data in H1 2024 SAN DIEGO / Nov 27, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver... Read More

Expected cash runway extended to the end of 2026 $35 million milestone achieved under CSL collaboration ARCT-154 remains on track for Japan-NDA approval in December Enrollment target reached in Phase 3 bivalent COVID vaccine comparison trial Enrollment initiated in ARCT-032 Phase 1b study; dosing first cystic fibrosis patient this month ARCT-032 received Rare Pediatric Disease Designation for cystic fibrosis from the FDA... Read More

SAN DIEGO / Oct 25, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, today announced that it will release its financial results for the quarter ended September 30, 2023 after the... Read More

SAN DIEGO / Oct 23, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the Company will participate in the following investor and scientific conferences. 11 th International... Read More

$165 million in manufacturing grants awarded to ARCALIS by the Japanese government SAN DIEGO / Oct 04, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, announced today that ARCALIS, Arcturus’... Read More

CF Foundation Increases Financial Commitment to ~$25 Million SAN DIEGO / Sep 26, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, announced today that Arcturus and the Cystic Fibrosis Foundation... Read More

Late-breaking data presented at 9 th ESWI Influenza Conference in Valencia SAN DIEGO / Sep 19, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced the results of a phase 1/2 study... Read More

EMA application supported by Phase 3 primary vaccination study demonstrating primary efficacy endpoint was met An additional Phase 3 booster study demonstrating non-inferiority of immune response compared to Comirnaty® and superiority of ARCT-154 in neutralizing antibody response against SARS-CoV-2 Omicron BA.4/5 variant was shown as a key secondary endpoint SAN DIEGO / Sep 05, 2023 / Business Wire / Arcturus Therapeutics... Read More

SAN DIEGO / Aug 17, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the Company will participate in the following investor conferences: Citi’s 18 th Annual BioPharma... Read More

LUNAR-FLU collaboration with CSL Seqirus achieves additional $17.5 million development milestone SAN DIEGO / Aug 14, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease... Read More

ARCT-154 Phase 3 COVID-19 booster trial achieved primary endpoint demonstrating strong immune response and favorable safety profile Meiji Seika Pharma submitted ARCT-154 New Drug Application in Japan New ARCT-154 booster clinical data demonstrate one-year durability across a panel of variants Received FDA Fast Track... Read More

Arcturus to present at the Canaccord Genuity 43 rd Annual Growth Conference, August 9, 2023 SAN DIEGO / Jul 24, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, today announced that... Read More

SAN DIEGO / Jun 01, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ARCT-810, the... Read More

New Drug Application (NDA) for ARCT-154, a next generation COVID-19 vaccine, was submitted in Japan, leading to potential approval in 2023 $23.6 Million advanced for the manufacturing and supply of ARCT-154 ARCT-032 Phase 1 enrollment and administration completed successfully; trial expansion to include Cystic Fibrosis patients planned in third quarter Investor conference call at 4:30 p.m. ET today SAN DIEGO / May 09, 2023 /... Read More

SAN DIEGO / Apr 26, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, today announced that it will release its financial results for the quarter ended March 31, 2023 after the market... Read More

$200 million upfront payment received in December 2022 from CSL collaboration Achieved $90 million in development milestones in March 2023 under CSL collaboration ARCT-154 Phase 3 COVID-19 booster trial enrollment completed in Japan Multiple patients enrolled in ARCT-810 Phase 2 multiple ascending dose trial for OTC deficiency ARCT-032 Phase 1 Cystic Fibrosis trial initiated and enrollment of first two cohorts successfully... Read More

SAN DIEGO / Mar 07, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company,” “Arcturus,” Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, today announced that it will release its financial results for the quarter and year ended December 31, 2022 after... Read More

SAN DIEGO / Feb 06, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical 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 Company will participate in the following investor conferences: SVB Securities Global... Read More

SAN DIEGO / Jan 31, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, “Arcturus Therapeutics”, Nasdaq: ARCT), a global late-stage clinical 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 Clinical Trial Application (CTA) for ARCT-032, an inhaled... Read More

CSL to access late-stage next-generation mRNA platform technology, enabling development of vaccines for COVID-19, influenza, multi-pathogen pandemic preparedness and other respiratory pathogens KING OF PRUSSIA, Pa. , Dec. 12, 2022 /PRNewswire/ -- CSL Limited (ASX:CSL; USOTC:CSLLY) today announced that its subsidiary, CSL Seqirus, finalized its global collaboration and license agreement with Arcturus Therapeutics Holdings Inc... Read More