Arcturus Therapeutics

Arcturus Therapeutics Announces Positive Development for Cystic Fibrosis Program

Retrieved on: 
Dienstag, Mai 28, 2024
Biotechnology, Health, General Health, Pharmaceutical, Health Technology, Research, Infectious Diseases, Genetics, Science, COVID-19, Clinical Trials, Patient, Liver, Messenger, Therapy, European, Conference, Cystic fibrosis, Spirometry, RNA, Arcturus Therapeutics, ARCT, FEV1, Pharmaceutical industry

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 rare diseases, today announced Arcturus will be presenting Phase 1 results in healthy volunteers and new Phase 1b interim data in CF patients for ARCT-032, an inhaled investigational mRNA therapeutic to treat CF, at the 47th European Cystic Fibrosis Conference on June 7, 2024.

Key Points: 
  • 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 rare diseases, today announced Arcturus will be presenting Phase 1 results in healthy volunteers and new Phase 1b interim data in CF patients for ARCT-032, an inhaled investigational mRNA therapeutic to treat CF, at the 47th European Cystic Fibrosis Conference on June 7, 2024.
  • “We were pleased to observe ARCT-032 treatments for the first four patients were generally safe and well tolerated with no serious adverse events,” said Joseph Payne, President & CEO of Arcturus Therapeutics.
  • “Furthermore, we observed an encouraging trend towards lung function improvements in the first four CF participants after only two inhaled administrations.”
    “The absolute change in percent predicted FEV1 (Forced Expiratory Volume in 1 second) in the first four CF participants was observed to be an average of 4.0% at day 8,” said Dr. Juergen Froehlich, Chief Medical Officer of Arcturus Therapeutics.
  • “I am pleased to announce our team will present this new Phase 1b interim data at the upcoming European CF conference in Scotland, supplementing the favorable results from our Phase 1 single ascending dose study in healthy volunteers.”

Nature Communications Publishes Pivotal Data Demonstrating Efficacy and Tolerability of CSL and Arcturus Therapeutics’ COVID-19 Vaccine

Retrieved on: 
Montag, Mai 20, 2024
COVID-19, Research, Infectious Diseases, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, ASX, Arcturus, Risk, CSL, Nature Communications, Messenger, Therapy, Ageing, Disease, Safety, Public, Person, Senior, Arcturus Therapeutics, ARCT, Vaccine

Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announce Nature Communications has published results from an integrated phase 1/2/3a/3b study evaluating the safety, immunogenicity, and efficacy of ARCT-154, a novel self-amplifying (sa-mRNA) COVID-19 vaccine and the world’s first approved sa-mRNA COVID-19 vaccine.

Key Points: 
  • Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announce Nature Communications has published results from an integrated phase 1/2/3a/3b study evaluating the safety, immunogenicity, and efficacy of ARCT-154, a novel self-amplifying (sa-mRNA) COVID-19 vaccine and the world’s first approved sa-mRNA COVID-19 vaccine.
  • 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.
  • “The results published in Nature Communications demonstrate the efficacy and tolerability of ARCT-154 and add to a growing body of evidence that our sa-mRNA vaccine has the potential to provide significant protection against the pervasive virus, reinforcing our promise to protect public health,” said Jon Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL.
  • “We are thrilled that the results of the ARCT-154 study have been published in the highly respected journal Nature Communications,” said Pad Chivukula, Ph.D., Chief Scientific Officer of Arcturus Therapeutics.

Arcturus Therapeutics Announces First Quarter 2024 Financial Update and Pipeline Progress

Retrieved on: 
Mittwoch, Mai 8, 2024
Biotechnology, Infectious Diseases, COVID-19, Health, Pharmaceutical, Society, COVID, Investment, Meiji, ARCT, Ornithine transcarbamylase deficiency, Safety, SARS-CoV-2, Travel, European Commission, Research, OTC, Cystic fibrosis, Lyme disease, RNA, MAA, Inborn errors of metabolism, Trial of the century, Vaccine, CDMO, Omicron, SRR, GMT, SAD, Liver, CSL, EMA, JPMorgan Chase, SIMD, Civil service commission, Infection, Messenger, Arcturus Therapeutics, Therapy, European Medicines Agency, Pharmaceutical industry

“Arcturus continues to make encouraging progress in both our vaccine and therapeutics pipeline,” said Joseph Payne, President & CEO of Arcturus.

Key Points: 
  • “Arcturus continues to make encouraging progress in both our vaccine and therapeutics pipeline,” said Joseph Payne, President & CEO of Arcturus.
  • To support this effort, Arcturus along with CDMO partners are on track to deliver the initial 4 million commercial doses of Kostaive in Q3.
  • The Company will share a progress update on the Phase 2 study on July 1, 2024.
  • The expected cash runway extends at least three years based on the current pipeline and programs through the first quarter of fiscal year 2027.

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

Retrieved on: 
Donnerstag, April 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

Retrieved on: 
Donnerstag, März 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

Retrieved on: 
Donnerstag, März 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

Retrieved on: 
Donnerstag, Februar 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

Retrieved on: 
Montag, Februar 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

Retrieved on: 
Montag, Februar 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

Retrieved on: 
Freitag, Januar 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.