Arcturus Therapeutics

Orphan designation: mRNA encoding the human CFTR gene Treatment of cystic fibrosis, 19/02/2024 Positive

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목요일, 4월 18, 2024
Patient, Committee, Arcturus Therapeutics, Messenger, EMA, IRIS, European, Therapy, COMP, European Commission, CFTR, Marketing, Cystic fibrosis, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of cystic fibrosis in the European Union on 19 February 2024.
  • Orphan designation does not mean the medicine is available or authorised for use.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

COVID-19 Monthly Newsletter Service - ResearchAndMarkets.com

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목요일, 3월 14, 2024
Biotechnology, Pharmaceutical, Publishing, Health, FDA, COVID-19, Communications, Clinical Trials, MHLW, CSL, Abivax, AstraZeneca, Partnership, University, Ageing, EUL, Arcturus Therapeutics, UNICEF, Bharat Biotech, Ministry of Health, XBB, Messenger, Laboratory, World Health Organization, OTC, Therapy, Johnson & Johnson, Vaccination, Rapid antigen test, Phase II, WHO, CSL Limited, Ministry, Vaccine, Marketing, Fulcrum, UN, Pharmaceutical industry

The "COVID-19 Monthly Snapshot" newsletter has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "COVID-19 Monthly Snapshot" newsletter has been added to ResearchAndMarkets.com's offering.
  • In November 2023, 64 investigational drugs were active in Phase 3 of clinical development.
  • Globally, the overall confirmed cases of COVID-19 reached more than 772 million as of November 22, 2023.
  • Fifty-eight COVID-19 vaccines were evaluated in Phase 3, 40 in Phase 2, 84 in Phase 1, and 199 in pre-clinical stages.

Arcturus Therapeutics Announces Fourth Quarter and Fiscal Year 2023 Financial Update and Pipeline Progress

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목요일, 3월 7, 2024
COVID-19, Research, Infectious Diseases, FDA, Biotechnology, Health, Pharmaceutical, General Health, Science, Pfizer–BioNTech COVID-19 vaccine, Liver, European Commission, Ministry, Arcturus Therapeutics, Messenger, Ornithine transcarbamylase deficiency, Investment, Omicron, OTC, Lyme disease, CSL, MHLW, The Lancet, Vaccine, Gonorrhea, Observation, RNA, Civil service commission, Collaboration, Therapy, COVID, Ministry of Health, Patient, Valence (chemistry), Janssen, Immunity, Orphan, ARCT, Travel, Infection

“I am excited about the continued pipeline progress and efforts toward commercialization achieved by Arcturus in 2023,” said Joseph Payne, President & CEO of Arcturus Therapeutics.

Key Points: 
  • “I am excited about the continued pipeline progress and efforts toward commercialization achieved by Arcturus in 2023,” said Joseph Payne, President & CEO of Arcturus Therapeutics.
  • This marks the first marketing approval milestone for CSL and Arcturus since signing the Collaboration and License agreement in November 2022.
  • In November 2023, Arcturus received Orphan Drug Designation from the U.S. FDA for ARCT-032, for the treatment of Cystic Fibrosis.
  • We have achieved a total of approximately $396.0 million in upfront payments and milestones from CSL as of December 31, 2023.

Arcturus Therapeutics Receives Orphan Medicinal Product Designation from the European Commission (EC), for ARCT-032, for the Treatment of Cystic Fibrosis

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목요일, 2월 22, 2024
Health, Other Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Therapy, Liver, European Commission, EMA, Arcturus Therapeutics, Person, FDA, Food, Civil service commission, RNA, European Medicines Agency, Research, ARCT, Cystic fibrosis, Pharmaceutical industry

In November 2023, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to ARCT-032 for CF.

Key Points: 
  • In November 2023, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to ARCT-032 for CF.
  • Orphan medicinal product designation by the EC is available to novel therapeutics that prevent or treat life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 persons in the EU.
  • “We are pleased to receive orphan medicinal product designation from the EC for ARCT-032, as it represents a significant milestone for our CF program,” said Joseph Payne, President & CEO of Arcturus Therapeutics.
  • Arcturus remains on track to share interim Phase 1b data in H1 2024.

New COVID-19 sa-mRNA Results from CSL and Arcturus Therapeutics Demonstrate Longer Duration of Immunity Compared to Conventional COVID-19 mRNA Vaccine Booster

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월요일, 2월 5, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, COVID-19, Infectious Diseases, Clinical Trials, Pfizer–BioNTech COVID-19 vaccine, SARS-CoV-2, Senior, RNA, Arcturus, ARCT, GMT, Messenger, CSL, Therapy, ASX, Arcturus Therapeutics, Vaccine

Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announced the results of a follow-up analysis of a Phase 3 study evaluating a booster dose of ARCT-154, the world's first approved self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine, compared to a conventional mRNA COVID-19 vaccine.

Key Points: 
  • Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announced the results of a follow-up analysis of a Phase 3 study evaluating a booster dose of ARCT-154, the world's first approved self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine, compared to a conventional mRNA COVID-19 vaccine.
  • ARCT-154 was administered at one-sixth the dose of Comirnaty® (5 μg vs 30 μg, respectively).
  • “These results further support sa-mRNA’s differentiating attribute to provide prolonged protection against COVID-19 at lower doses,” said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL.
  • GMTs against Wuhan-Hu-1 remained numerically higher 180 days after ARCT-154 than those observed 28 days after the Comirnaty® booster.

New COVID-19 sa-mRNA Results from CSL and Arcturus Therapeutics Demonstrate Longer Duration of Immunity Compared to Conventional COVID-19 mRNA Vaccine Booster

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월요일, 2월 5, 2024
Pfizer–BioNTech COVID-19 vaccine, COVID-19, SARS-CoV-2, SAN, Senior, RNA, Arcturus, ARCT, GMT, Messenger, CSL, Therapy, ASX, Arcturus Therapeutics, Vaccine

KING OF PRUSSIA, Pa. and SAN DIEGO, Feb. 5, 2024 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announced the results of a follow-up analysis of a Phase 3 study evaluating a booster dose of ARCT-154 , the world's first approved self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine, compared to a conventional mRNA COVID-19 vaccine. ARCT-154 was administered at one-sixth the dose of Comirnaty® (5 μg vs 30 μg, respectively).

Key Points: 
  • ARCT-154 was administered at one-sixth the dose of Comirnaty® (5 μg vs 30 μg, respectively).
  • 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.
  • "These results further support sa-mRNA's differentiating attribute to provide prolonged protection against COVID-19 at lower doses," said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL.
  • GMTs against Wuhan-Hu-1 remained numerically higher 180 days after ARCT-154 than those observed 28 days after the Comirnaty® booster.

PassPort Technologies Commences Collaborative Research with Arcturus Therapeutics to Evaluate Transdermal mRNA delivery systems

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금요일, 1월 5, 2024
Messenger, Research, Vaccine, Arcturus Therapeutics, ARCT, Knowledge, Therapy, Passport

SAN DIEGO, Jan. 5, 2024 /PRNewswire/ -- PassPort Technologies, Inc. (PPTI), led by President and CEO Tomoyuki Fujisawa in California, USA is pleased to announce the initiation of a collaborative research endeavor with Arcturus Therapeutics (ARCT). This research collaboration is focused on evaluating innovative mRNA formulations and transdermal delivery mechanisms for vaccines and therapeutics.

Key Points: 
  • Arcturus's mRNA medicines and vaccines and lipid-mediated drug delivery systems in combination with PassPort's innovative transdermal drug delivery system.
  • SAN DIEGO, Jan. 5, 2024 /PRNewswire/ -- PassPort Technologies, Inc. (PPTI), led by President and CEO Tomoyuki Fujisawa in California, USA is pleased to announce the initiation of a collaborative research endeavor with Arcturus Therapeutics (ARCT).
  • This research collaboration is focused on evaluating innovative mRNA formulations and transdermal delivery mechanisms for vaccines and therapeutics.
  • The research collaboration will leverage ARCT's expertise in mRNA design and proprietary LUNAR® platform technologies, alongside PPTI's groundbreaking PassPort® transdermal drug delivery technology.

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

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목요일, 12월 21, 2023
Science, Biotechnology, Research, Pharmaceutical, Health, COVID-19, Infectious Diseases, Clinical Trials, SRR, RNA, ASX, Partnership, Multimedia, Messenger, Vaccine, Arcturus Therapeutics, Therapy, Vaccination, GMT, Omicron, CSL, ARCT, Patient, Arcturus, Safety, Senior

ARCT-154 results were achieved with one sixth the dose of Comirnaty® (5 μg vs 30 μg).

Key Points: 
  • ARCT-154 results were achieved with one sixth the dose of Comirnaty® (5 μg vs 30 μg).
  • The study was conducted in partnership with Meiji Seika Pharma, a global health company based in Japan.
  • The primary objective was to demonstrate immunological non-inferiority of ARCT-154 to Comirnaty®, as measured by neutralizing antibodies against Wuhan-Hu-1 SARS-CoV-2.
  • Key secondary objectives included the assessment of immunological non-inferiority and superiority against the Omicron BA.4/5 subvariant and vaccine tolerability assessed using participant-completed electronic diaries.

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

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목요일, 12월 21, 2023
SRR, RNA, Senior, ASX, Partnership, Messenger, Vaccine, Arcturus Therapeutics, SAN, Therapy, Vaccination, GMT, Omicron, CSL, COVID-19, Doctor of Philosophy, Upendra J. Chivukula, Patient, Arcturus, Safety

KING OF PRUSSIA, Pa. and SAN DIEGO, Dec. 21, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announced the publication in Lancet Infectious Diseases of a Phase 3 study showing that a booster dose of ARCT-154, a novel, self-amplifying messenger RNA (sa-mRNA) vaccine, elicited a numerically higher immune response (meeting the non-inferiority criteria) against the original Wuhan-Hu-1 virus strain,  and a superior immune response against Omicron BA.4/5 subvariant of SARS-CoV-2 virus compared to a booster dose of the conventional mRNA vaccine Comirnaty®. ARCT-154 results were achieved with one-sixth the dose of Comirnaty® (5 μg vs 30 μg).

Key Points: 
  • Both vaccines were well-tolerated, with no causally associated severe or serious adverse events.
  • The study was conducted in partnership with Meiji Seika Pharma, a global health company based in Japan.
  • "This study represents the first phase of CSL and Arcturus' plans to launch this innovative vaccine platform globally."
  • Key secondary objectives included the assessment of immunological non-inferiority and superiority against the Omicron BA.4/5 subvariant and vaccine tolerability assessed using participant-completed electronic diaries.

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

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화요일, 11월 28, 2023
Biotechnology, Infectious Diseases, COVID-19, Health, Pharmaceutical, Ministry, CSL, MHLW, Senior, Nobel, Therapy, MedRxiv, Risk, Vaccination, Multimedia, Ministry of Health, ASX, ARCT, Messenger, Arcturus Therapeutics, Public, COVID, Vaccine, Arcturus

Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted approval for ARCT-154, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for initial vaccination and booster for adults 18 years and older.

Key Points: 
  • Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted approval for ARCT-154, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for initial vaccination and booster for adults 18 years and older.
  • Initial study results have been published in MedRxiv and are expected to be published in a peer-reviewed journal by the end of the year.
  • "This approval for the sa-mRNA COVID-19 vaccine is a major achievement, and we are excited to embark on future endeavors that utilize our innovative sa-mRNA vaccine platform alongside our global exclusive partner, CSL."
  • CSL's vaccine business, CSL Seqirus, one of the largest influenza vaccine providers in the world, partnered exclusively with Meiji Seika Pharma for distribution of the sa-mRNA COVID vaccine, ARCT 154, in Japan.