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Recent News Releases

For investor-related news, see our ASX releases on our parent company's website: CSL.com.

Coronavirus Information

During the COVID-19 outbreak, CSL Behring is here for our patients and our larger world community.

Ukraine Information

CSL condemns the invasion of Ukraine and we are supporting multiple humanitarian relief efforts to help those impacted by this unjust act.

U.S. Food and Drug Administration approves CSL’s HEMGENIX® (etranacogene dezaparvovec-drlb), the first gene therapy for hemophilia B

22 Nov 2022

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.

Next-Generation mRNA, Gene Therapy, Plasma Products, Monoclonal Antibodies, and Recent Acquisitions and Collaborations Highlight CSL R&D Day 2022

02 Nov 2022

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

Cicada Innovations to Operate New Biotech Incubator

02 Nov 2022

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.

CSL and Translational Sciences enter Agreement

26 Oct 2022

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

CSL Receives Manufacturing and Marketing Authorization in Japan for “Berinert® S.C. Injection 2000,” as a Medicine for prevention of Acute Hereditary Angioedema (HAE) attacks

26 Sep 2022

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 Issues Preliminary Injunction of Plasma Ban by CBP

19 Sep 2022

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.

CSL presents new research and development center in Marburg, Germany

13 Sep 2022

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.

Orphan Drug Designation granted for etranacogene dezaparvovec, CSL’s gene therapy for haemophilia B, by the Therapeutics Goods Administration

08 Sep 2022

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

CSL Announces Positive Top-Line Phase 3 Results for Garadacimab as Preventive Treatment in Patients with Hereditary Angioedema (HAE)

17 Aug 2022

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

COVID-19 Update

24 Jun 2022

CSL continues to provide medicines to patients around the world.

Acclaimed Photographer Rankin and CSL Behring Team Up to Launch ‘Portraits of Progress’, an Exhibition Chronicling the Past, Present and Future of Life with Hemophilia

09 Jun 2022

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

FDA Accepts CSL Behring’s Biologics License Application for Etranacogene Dezaparvovec for Priority Review

24 May 2022

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

Ruling by DC Circuit Court of Appeals Provides CSL the Right to Challenge CBP’s Plasma Ban

10 May 2022

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

CSL Behring Donates 500 Million International Units of Coagulation Factor Replacement Therapy to the World Federation of Hemophilia Humanitarian Aid Program to Help Those Living with Bleeding Disorders

28 Apr 2022

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.

European Medicines Agency Commences Review of Novel Gene Therapy Candidate Etranacogene Dezaparvovec for People with Hemophilia B

28 Mar 2022

- 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.

Forbes Magazine Ranks Global Biotech Leader CSL Among America’s Best Employers for 2022

02 Mar 2022

KING OF PRUSSIA, Pa.

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

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

04 Feb 2022

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

uniQure and CSL Behring Announce Primary Endpoint Achieved in HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B

09 Dec 2021

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

Clinical Trial Milestones, Investments in aQIVc and sa-mRNA Influenza Vaccines and New Strategic Collaborations Among the Highlights from CSL R&D Day

18 Oct 2021

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

Resources for Media

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CSL Behring Media Contacts

Tom Hushen

Corporate Inquiries
King of Prussia, PA, USA
Phone: +1 267-769-6728

Greg Healy

Hematology, Respiratory and Transplant Inquiries
King of Prussia, PA, USA

Valerie Bomberger

Immunology and Cardiovascular & Metabolic Inquiries
King of Prussia, PA, USA
Phone: +1 267-280-3829

Stephanie Fuchs

Corporate Inquiries, Europe
Hattersheim am Main, Hesse, Germany
Phone: +49 151 5843 8860

CSL Behring Production Sites

Sandra Ruckstuhl

Bern, Switzerland
Phone: +41 31-344-1124

Maureen E. Powell

Kankakee, Illinois, USA
Phone: +1 815-935-3120

Stephanie Fuchs

Marburg, Germany
Phone: +49 151 58438860

Australian Media Contact

Broadmeadows, Victoria, Australia
Mobile: +61 0450 909 211
Email: media@csl.com.au (non-urgent enquires)

CSL Plasma:
For any CSL Plasma corporate or donation inquiries, please refer to the CSL Plasma website for more information.

Archived News Releases