Global Newsroom

KING OF PRUSSIA, PA, USA

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 levels for years after a one-time infusion.

MELBOURNE, Australia and KING OF PRUSSIA, Pennsylvania

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

MELBOURNE, VIC, AUSTRALIA

CSL, WEHI and The University of Melbourne jointly announce the appointment of Cicada Innovations as the independent operator of the new biotech incubator which will be located in CSL’s new Global Headquarters currently under construction in the Melbourne Biomedical Precinct.

Option to acquire exclusive, global license to enhanced thrombus dissolving drug candidate TS23

KING OF PRUSSIA, PA

At-home subcutaneous therapy advances treatment options for patients and marks a milestone in 40 years of delivering on CSL’s promise to the HAE patient Community

United States District Court has issued a preliminary injunction preventing the United States Customs and Border Protection (CBP) from continuing to enforce its ban on plasma donations by Mexican nationals.

MARBURG, GERMANY
The new facility, once fully open later this calendar year, will be CSL’s largest R&D site under one roof, with more than 500 team members working in a state-of-the-art facility offering access to promising scientific partners and talent.

MELBOURNE, VIC, AUSTRALIA
TGA’s designation underscores CSL’s promise to develop and deliver a truly unique portfolio of patient-focused therapies for people with rare and serious medical conditions

KING OF PRUSSIA, PA

CSL is on track to file for regulatory approvals next year and will present full data set at an upcoming scientific congress

CSL continues to provide medicines to patients around the world.

KING OF PRUSSIA, PA, USA

Rankin’s first in-person U.S. exhibit in three years showcases portraits and personal stories highlighting the remarkable progress made in understanding and treating hemophilia and hopes for the future

KING OF PRUSSIA, PA, USA
- If approved, etranacogene dezaparvovec would be the first gene therapy option for people living with hemophilia B
- This milestone underscores CSL Behring’s promise to develop and deliver a truly unique portfolio of patient-focused therapies for people with rare and serious medical conditions

Statement attributable to Greg Boss, Executive Vice President - Legal, and CSL Limited Group General Counsel.

The 500 million international units (IUs) will include product specifically manufactured for donation allowing for a longer shelf life and enabling more people around the world to access life-saving therapy.

- Marketing Authorization Application (MAA) for etranacogene dezaparvovec will be reviewed under accelerated assessment and has the potential to be the first gene therapy for patients living with hemophilia B.
- MAA filing is supported by the phase 3 HOPE-B study which demonstrated durable and sustained therapeutic effect after a single infusion.
- Milestone underscores CSL Behring’s promise to develop and deliver a truly unique portfolio of patient-focused therapies.

KING OF PRUSSIA, Pa.

With 25,000 global employees, CSL is one of 500 Large Employers recognized across 25 industry sectors

KING OF PRUSSIA, PA

- Data from the largest gene therapy study in Hemophilia B to date shows that etranacogene dezaparvovec is statistically superior in reducing annualized bleeding rate compared to baseline FIX prophylactic therapy
- Following a single administration of etranacogene dezaparvovec, participants maintained stable Factor IX (FIX) activity through 18 months
- Therapeutic benefit observed in patients with pre-existing anti-capsid neutralizing antibody levels up to a titer of 1:678

KING OF PRUSSIA, PA, USA

Lexington, MA and Amsterdam, the Netherlands, King of Prussia, PA

~ Largest gene therapy study in hemophilia B achieved primary endpoint of non-inferiority in annualized bleeding rate after stable Factor IX (FIX) expression, assessed at 18 months following a single dose of etranacogene dezaparvovec
~ Etranacogene dezaparvovec also achieved secondary endpoint demonstrating statistical superiority in reduction of annualized bleeding rate compared to baseline FIX prophylactic therapy
~ Stable and durable FIX levels with mean FIX activity of 36.9 percent of normal in full study population at 18-months, compared to a mean of 39.0 percent of normal at 6 months
~ Manufacturing operations supporting process validation of etranacogene dezaparvovec successfully completed by uniQure

KING OF PRUSSIA, PA and MELBOURNE, AU

• CSL advances novel pipeline spanning six therapeutic areas, four scientific platforms and two businesses (CSL Behring and Seqirus)
• Seqirus Awarded BARDA contract to develop aQIVc and sa-mRNA Pandemic Influenza Vaccines
• New collaboration with the Walter and Eliza Hall Institute for Medical Research in Australia to create a Centre for Biologic Therapies