Press Releases

SMC accepts CSL Behring’s HEMGENIX® (etranacogene dezaparvovec) for use on an interim basis in Scotland as the first single infusion gene therapy for adults with severe or moderately severe haemophilia B without a history of FIX inhibitors

Global biotechnology leader CSL Behring (ASX: CSL) today announced that two hemophilia B patients were treated with the gene therapy HEMGENIX® (etranacogene dezaparvovec) at Hemophilia Treatment Centers in France.

NICE recommends CSL Behring’s HEMGENIX® (etranacogene dezaparvovec) as the first single infusion gene therapy for adults with severe or moderately severe haemophilia B without a history of FIX inhibitors for reimbursement via a managed access agreement, recognising the treatment as cost-effective in England.

Global biotechnology leader CSL Behring (ASX: CSL) has been granted Direct Access for HEMGENIX® (etranacogene dezaparvovec) by the French Ministry of Health, marking the first treatment to be authorised by this innovative process in France.

Dr Niklas Schier will join the management of CSL Behring GmbH as the third Managing Director alongside Michael Schroeder and Dr Lutz Bonacker and take over the management of the production site in Marburg from Michael Schroeder as of 1 January 2024.

CSL’s Global Research Acceleration Initiative Freshly Inks Promising Research Partnerships in Europe and, for the first time, Asia and the UK

Significant reduction in number of attacks support the potential of once-monthly garadacimab as a prophylactic therapy for patients with hereditary angioedema

Approval of HEMGENIX® underscores CSL Behring’s promise to deliver life-changing innovations that have the potential to help patients lead full lives

Regulatory milestone moves CSL one step closer to bringing the promise of gene therapy for hemophilia B to patients in Europe

Pipeline advancements and investment in innovation and disruptive technologies to help fuel sustainable, profitable growth for CSL’s three businesses, CSL Behring, CSL Seqirus and CSL Vifor, in the decades ahead

500 Million IUs Coagulation Factor Replacement Therapy for the World Federation of Hemophilia Humanitarian Aid Program

EMA Commences Review of Novel Gene Therapy Candidate Etranacogene Dezaparvovec for People with Hemophilia B

Final Analysis of Pivotal HOPE-B Study Demonstrates Durable and Sustained Therapeutic Effect of Etranacogene Dezaparvovec Gene Therapy in Hemophilia B – Data Presented at EAHAD 2022

• Etranacogene dezaparvovec (AMT-061) is an investigational gene therapy that may potentially provide people with hemophilia B with years of functional levels of Factor IX, a blood-clotting protein that prevents excessive bleeding.

• uniQure will complete the Phase 3 HOPE-B trial and scale up manufacture for initial commercial supply under an agreed plan with CSL Behring.

Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints to show efficacy in adults hospitalized with COVID-19

CSL Dispatches First Australian Made Doses of the AstraZeneca COVID 19 Vaccine.