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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.

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

COVID-19 Update

26 Jan 2022

CSL continues to provide medicines to patients around the world.

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

CSL Launches Annual Scholarship Program with Seven Greater Chicago Area Students Receiving Awards

05 Oct 2021

Kankakee, IL

CSL introduced a scholarship program for U.S. employees and their dependents as part of delivering on its promise to diversity, equity and inclusion.

CSL’s Global Role in Battling COVID-19

17 Sep 2021

Here's how CSL is working around the world with academia, industry and governments to combat COVID-19

Urban League of Philadelphia Names CSL’s Elizabeth Walker to Board of Directors

09 Sep 2021

KING OF PRUSSIA, Pa. and PHILADELPHIA, Pa.

Global biotech leader CSL and the Urban League of Philadelphia are working to address some of the most pressing needs in the community, including efforts to strengthen Public Health, Leadership Development, Workforce Diversity and Job Creation and Training.

The European Academy of Neurology (EAN) and Peripheral Nerve Society (PNS) Task Force Has Strongly Recommended Subcutaneous Immunoglobulin (SCIg) for CIDP Maintenance Treatment

09 Aug 2021

King of Prussia, Pa.

The updated guideline empowers physicians with the confidence to expand the treatment options prescribed for CIDP patients

FDA Approves New BERINERT® (C1 Esterase Inhibitor, Human (Intravenous)) Administration Kit for Increased Patient Convenience

03 Aug 2021

KING OF PRUSSIA, PA

Approval received to co-package a convenience administration kit along with the product BERINERT.

Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) To Be Covered Under Medicare Part B Effective July 18, Improving Access and Reducing Out-of-Pocket Costs for CIDP Patients

08 Jun 2021

KING OF PRUSSIA, Pa.

Hizentra will be covered under the same Medicare benefit category as intravenous immune globulin (IVIg), but with the convenience of self-infusing at home

New Meta-Analysis of Patients with Acute Coronary Syndrome Shows Nearly Half of Recurrent Major Adverse Cardiovascular Events at One Year Occur Within the First 90 Days

16 May 2021

KING OF PRUSSIA, Pa.

Findings signal need for novel treatment strategies to provide more protection during this high-risk, 90-day period

Lyfebulb and CSL Behring Announce the Winner of the 2021 Transplant Innovation Challenge

13 May 2021

NEW YORK, NY, USA

Dr. Minnie Sarwal of NephroSant has been selected to receive the $25,000 Innovation Award

CSL Behring Announces Closing of Global Commercialization and License Agreement with uniQure for etranacogene dezaparvovec

06 May 2021

KING OF PRUSSIA, PA

• 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.

Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) Label Update Provides New Dosing Guidelines for Physicians, Allowing for Greater Flexibility in Treating CIDP Patients

29 Apr 2021

King of Prussia, Pa

The label update is based on open label extension data from the landmark PATH (Polyneuropathy And Treatment with Hizentra) study

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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
Phone: +1 610-878-4841

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

Christina Hickie

Broadmeadows, Victoria, Australia
Phone: +61 429 609 762

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

Archived News Releases