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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 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 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; ...
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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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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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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 Honoured as Overall Winner of the 2025 Facility of the Year Awards by the International Society for Pharmaceutical Engineering (ISPE)

Purpose-built to optimise the production of plasma-derived therapies for conditions such as immunodeficiencies, neurological disorders, and burns, the Broadmeadows facility combines cutting-edge ...
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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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CSL's Garadacimab, a First-in-Class Factor XIIa Inhibitor, Receives FDA and EMA Filing Acceptance

These regulatory milestones bring CSL one step closer to delivering on our promise to patients with a first-in-class recombinant monoclonal antibody for people living with HAE, a community CSL has ...
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Data Published in the New England Journal of Medicine Confirm the Long-term Durability and Safety of HEMGENIX® (etranacogene dezaparvovec-drlb) Over Five Years

- 94% of patients (51 of 54) remained free from the burden of continuous prophylaxis treatment through five years following a single infusion of HEMGENIX, demonstrating sustained therapeutic benefit - ...
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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 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 ...