Csl Ltd - CSLLY STOCK NEWS

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.

On November 24, 2023, the global coalition for Iron Deficiency Day is focusing on the importance of early diagnosis and treatment of iron deficiency and anemia. This initiative aims to raise awareness about the serious health impact of these conditions and their effect on quality of life. The company involved in this initiative is not specified in the press release.

Global biotechnology leader CSL and uniQure N.V. have won the 2023 Prix Galien USA Award for Best Product for Rare/Orphan Diseases for their gene therapy HEMGENIX®. HEMGENIX is the first and only FDA-approved gene therapy for adults with hemophilia B. It has also received conditional marketing authorization in the European Union and Canada.

CSL Seqirus announces new data supporting the effectiveness and value of cell-based and adjuvanted seasonal influenza vaccines