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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

This historic approval of the world's first Self-Amplifying messenger RNA (sa-mRNA) COVID-19 Vaccine underscores CSL's promise to develop and deliver innovations when there is a public health need ...
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U.S. Food and Drug Administration Approves CSL's ANDEMBRY® (garadacimab-gxii), the Only Prophylactic Hereditary Angioedema (HAE) Treatment Targeting Factor XIIa with Once ...

ANDEMBRY inhibits the top of the HAE cascade by targeting factor XIIa and provides sustained protection from attacks Once-monthly dosing reduced HAE attacks by a median of more than 99 percent and a ...
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CSL Announces Top-line Results from the Phase 3 AEGIS-II Trial Evaluating the Efficacy and Safety of CSL112 (apolipoprotein A-I [human])

KING OF PRUSSIA, Pa., Feb. 11, 2024 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced top-line results from the Phase 3 AEGIS-II trial evaluating the efficacy and ...
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World-class $1bn vaccine and antivenom manufacturing facility opens in Melbourne

Melbourne, Tuesday 2 December 2025 – Australia’s onshore vaccine manufacturing capabilities took a leap forward today as The Hon Mark Butler MP, Minister for Health, Disability and Ageing, opened CSL ...
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European Commission Approves CSL and Arcturus Therapeutics' KOSTAIVE®, the First Self-amplifying mRNA COVID-19 Vaccine

- KOSTAIVE represents a significant advancement in vaccine technology, demonstrating superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA ...
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U.S. Food and Drug Administration approves CSL's HEMGENIX® (etranacogene dezaparvovec-drlb), the first gene therapy for hemophilia B

- This historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates elevated and sustained factor IX ...
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CSL Behring's Gene Therapy HEMGENIX® (etranacogene dezaparvovec-drlb) Four Years Post-Infusion Data Continue to Show Sustained Efficacy and Safety in Adults with Hemophilia B

94 percent of patients eliminated factor IX prophylaxis and remained free of continuous prophylaxis through four years post-treatment Mean factor IX activity levels were sustained at near normal ...
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CSL announces rise in full year net profit

MELBOURNE, Aug. 18, 2025 /PRNewswire/ -- Global biotherapeutics leader CSL today announced a reported net profit after tax of US$3.0 billion for the 12 months ended 30 June 2025, up 17% on a constant ...
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CSL partners with VarmX in a strategic collaboration and option agreement to develop first-in-class investigational coagulation treatment

Melbourne, Australia – 16 September 2025 CSL today announced it has entered into a strategic collaboration with privately held Dutch biotech company VarmX BV to support the company’s development of ...
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European Commission Approves CSL's ANDEMBRY® (garadacimab) for the Prevention of Recurrent Attacks of Hereditary Angioedema (HAE)

- ANDEMBRY ®, the first and only once-monthly treatment targeting factor XIIa to prevent attacks in HAE patients, inhibits plasma protein factor XIIa, which initiates the cascade of events leading to ...
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Japan's Ministry of Health, Labor and Welfare Approves CSL and Arcturus Therapeutics' Updated Self-amplifying mRNA COVID-19 Vaccine for Protection against JN.1 Strain, to be ...

KING OF PRUSSIA, Pa. and SAN DIEGO, Sept. 13, 2024 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and sa-mRNA pioneer Arcturus Therapeutics today announced that Japan's ...
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CSL to invest approximately $1.5b in U.S. to manufacture plasma-derived therapies

Builds on company’s more than $3b U.S. investment since 2018 which created thousands of new jobs across 44 states KING OF PRUSSIA, PA, USA – November 18, 2025 — Global biopharma leader CSL (ASX:CSL; ...