Articles from Arcturus Therapeutics
Arcturus Therapeutics Receives Clearance of an Investigational New Drug Application to U.S. Food and Drug Administration for ARCT-032, an Investigational Inhaled mRNA Therapeutic to Treat Cystic Fibrosis
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 Investigational New Drug (IND) application, ARCT-032, to treat cystic fibrosis (CF). FDA clearance of the ARCT-032 IND application enables the Company to initiate a Phase 2 multiple ascending dose study to evaluate the safety, tolerability and efficacy of ARCT-032 in people with Cystic Fibrosis.
By Arcturus Therapeutics · Via Business Wire · September 3, 2024
Nature Communications Publishes Pivotal Data Demonstrating Efficacy and Tolerability of CSL and Arcturus Therapeutics’ COVID-19 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.
By Arcturus Therapeutics · Via Business Wire · May 20, 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
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).
By Arcturus Therapeutics · Via Business Wire · February 5, 2024
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
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).
By Arcturus Therapeutics · Via Business Wire · December 21, 2023
Arcturus Therapeutics to Attend Upcoming Investor Conferences
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:
By Arcturus Therapeutics · Via Business Wire · August 17, 2023
Arcturus Therapeutics Joint Venture mRNA Manufacturing Partner, ARCALIS, Awarded $115 Million in Grants from the Japanese Government
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 ARCALIS Co., Ltd., its manufacturing joint venture in Japan to support the production of mRNA vaccines and therapeutics, has been awarded $115 million in two separate grants from the Japanese government. The grants will be used to fund the construction of a factory and the purchase of capital equipment to support current Good Manufacturing Practice (cGMP) production of mRNA drug substance and mRNA drug product operations.
By Arcturus Therapeutics · Via Business Wire · August 14, 2023
Arcturus Therapeutics to Report First Quarter 2022 Financial Results and Provide Corporate Update on May 9, 2022
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, 2022 after the market close on Monday, May 9 and will also host a conference call and webcast at 4:30 pm Eastern Daylight Time on May 9, 2022.
By Arcturus Therapeutics · Via Business Wire · April 27, 2022
Arcturus Therapeutics to Report Fourth Quarter and Year-End 2021 Financial Results and Provide Corporate Update on February 28, 2022
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 it will release its financial results for the quarter and year ended December 31, 2021 after the market close on Monday, February 28 and will also host a conference call and webcast at 4:30 pm Eastern Standard Time on February 28, 2022.
By Arcturus Therapeutics · Via Business Wire · February 16, 2022
Arcturus Therapeutics Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
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 Compensation Committee of the Company’s Board of Directors and the Company’s Board of Directors approved inducement grants of stock options to purchase an aggregate of 5,800 shares of Arcturus’s common stock to one newly-hired employee. The equity awards were granted pursuant to the Nasdaq Rule 5635(c)(4) inducement grant exception as a component of each individual’s employment compensation and were granted as an inducement material to his or her acceptance of employment with the Company.
By Arcturus Therapeutics · Via Business Wire · January 21, 2022