CSL LTD SP/ADR - CSLLY STOCK NEWS

CSL and Arcturus Therapeutics announce positive results 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. The study conducted in Japan demonstrates Immunological Non-Inferiority to Wuhan Strain and Superior Immunogenicity to Omicron BA.4/5 Variant. The new analysis at 6 months post-vaccination shows that ARCT-154 induces a longer immune response compared to Comirnaty for both the original Wuhan strain and Omicron BA.4/5 variant, and an advantage in antibody persistence. The results follow the approval of the world's first sa-mRNA COVID-19 vaccine for adults by Japan Ministry of Health, Labor and Welfare in November 2023.

CSL Behring's survey results show that patients with CIDP prioritize convenience and flexibility in treatment, with a majority interested in exploring more convenient treatment options and administering treatment at home. However, less than half of the patients discuss potential new treatment options or switching treatments with a physician. The survey also revealed that patients wish their physicians better understood their priorities in CIDP treatment, including efficacy, minimal side effects, condition maintenance, at-home administration, and flexible dosing options.

CSL Behring (CSL) introduces a 10g prefilled syringe for Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid), the #1 immune globulin prescribed for Primary Immunodeficiency (PI) and the first and only subcutaneous immune globulin (SCIg) treatment approved for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in the U.S.

CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) 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 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). The study included healthy adults initially immunized with two doses of an mRNA vaccine (Comirnaty® or Spikevax™) and then a third dose of Comirnaty® at least three months prior to the booster dose of either ARCT-154 or Comirnaty® in the study. Both vaccines were well-tolerated, with no causally associated severe or serious adverse events.

CSL and Arcturus Therapeutics Announce Positive Phase 3 Results for ARCT-154 Sa-mRNA COVID-19 Vaccine

CSL (ASX:CSL; USOTC:CSLLY) announced that the FDA has accepted the company's Biologics License Application for garadacimab as a once-monthly prophylactic treatment for hereditary angioedema (HAE). The European Medicines Agency has also accepted the submission for CSL's Marketing Authorization Application for garadacimab. If approved, garadacimab would become the first treatment for HAE in the U.S. and EU to target activated Factor XII (FXIIa), with orphan-drug designation granted by both the FDA and EMA. The BLA and MAA are supported by data from the pivotal VANGUARD trial, with the ongoing open-label extension evaluating the long-term safety and efficacy of garadacimab in patients with HAE.

CSL (ASX: CSL; USOTC: CSLLY) announced the three-year results from the pivotal HOPE-B study confirming continued long-term durability and safety of HEMGENIX® (etranacogene dezaparvovec-drlb) gene therapy for hemophilia B. The treatment offers elevated and sustained factor IX activity levels for years, reducing the rate of annual bleeds and the need for regular prophylactic infusions.

CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics receive historic approval for ARCT-154, the world's first Self-Amplifying messenger RNA (sa-mRNA) COVID-19 Vaccine in Japan. This marks a significant milestone in CSL's promise to develop and deliver innovative vaccines to combat respiratory viral diseases, expanding their comprehensive portfolio.

CSL (CSL; CSLLY) and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor and Welfare granted approval for ARCT-154, a self-amplifying mRNA COVID-19 vaccine. This marks the first sa-mRNA vaccine in the world to be registered, highlighting CSL's commitment to global public health. The vaccine is approved for initial vaccination and booster for adults 18 years and older, based on positive clinical data from several studies. CSL Seqirus, in partnership with Meiji Seika Pharma, will distribute the vaccine in Japan.