Recent News Releases
For investor-related news, see our ASX releases here.
Sep 26, 2023CSL Seqirus secures multi-year pandemic preparedness agreement as part of its continued partnership with the UK government
CSL Seqirus will provide its registered pandemic influenza vaccine to the UK if an influenza pandemic occurs during the next four years. This new agreement to CSL Seqirus follows more than ten...
Sep 18, 2023CSL Seqirus Shares Data Demonstrating the Potential for Influenza Vaccination to Reduce the Burden on Healthcare Resources
CSL Seqirus presents new data at the 9th ESWI meeting on the impact of effective vaccination campaigns to protect healthcare systems across the world.1,2 The French data highlights how vaccines...
Sep 15, 2023CSL Seqirus to Present at 9th ESWI Conference on the Burden of Influenza and Impact of Vaccination on Public Health
SUMMIT, N.J., September 15, 2023 -- CSL Seqirus, a business of CSL (ASX:CSL), today announced new data that will be presented at the European Scientific Working Group on Influenza (ESWI)...
Sep 5, 2023Arcturus Therapeutics and CSL Announce European Medicines Agency Validates Marketing Authorization Application for ARCT-154 Vaccine to Prevent COVID-19
EMA application supported by Phase 3 primary vaccination study demonstrating primary efficacy endpoint was met An additional Phase 3 booster study demonstrating non-inferiority of immune response...
Aug 28, 2023
The 2023 European Society of Cardiology (ESC) guidelines for acute and chronic heart failure (HF) include upgraded recommendations for intravenous (IV) iron supplementation, including Ferinject®...
- Aug 27, 2023Prime Minister Anthony Albanese Opens CSL’s New Global Headquarters and Centre for Research & DevelopmentState-of-the-art facility strengthens Melbourne’s world-class biomedical precinct.
Melbourne, Australia – 21 August 2023 – Australia today ushered in a new era in scientific and medical innovation, with Prime Minister of Australia, Anthony Albanese officially opening CSL’s...
- Aug 17, 2023
Global biotechnology leader CSL (ASX: CSL) (USOTC: CSLLY) announced today that Jeffrey Ball, an established global leader across multiple disciplines and functions, has been appointed Chief...
Jul 17, 2023
CSL Seqirus is the only influenza vaccine manufacturer that offers differentiated vaccine options for individuals six months of age and older. Since the COVID-19 pandemic, there has been a...
- Jun 20, 2023CSL Behring Announces the First Patient Has Received FDA-Approved HEMGENIX® (etranacogene dezaparvovec-drlb) for Hemophilia B
HEMGENIX®, the first and only FDA approved gene therapy for hemophilia B, has been proven to elevate and sustain factor IX levels for years, significantly reduce the rate of annual bleeds versus...
Jun 5, 2023Injectafer® approved in the U.S. for the treatment of iron deficiency in patients with heart failure
Injectafer® (ferric carboxymaltose) is now the first and only intravenous (i.v.) iron replacement therapy in the U.S. indicated for improvement in exercise capacity in adult patients with...
May 21, 2023CSL Seqirus’ $800m+ innovative vaccine and antivenom manufacturing facility in Australia reaches major construction milestone
Melbourne, Monday 22 May CSL Seqirus has today announced that construction of its new state-of-the-art manufacturing facility in Australia has reached its highest point, known as ‘topping...
May 18, 2023Kapruvia® (difelikefalin) recommended by England's NICE for the treatment of adults with moderate-to-severe CKD-associated pruritus
Recommendation will enable eligible patients in England, Wales and Northern Ireland to access the first licensed treatment for moderate-to-severe chronic kidney disease (CKD)-associated pruritus...
- May 2, 2023Topline Results from Two-Year Primary Efficacy Endpoint in Pivotal Phase 3 DUPLEX Study of Sparsentan in Focal Segmental Glomerulosclerosis
The DUPLEX Study did not achieve the primary efficacy eGFR slope endpoint over 108 weeks of treatment Secondary and topline exploratory endpoints trended favorably for sparsentan Treatment with...
Apr 18, 2023CSL Behring Receives FDA Approval for Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) 50mL Prefilled Syringe
Hizentra® is the first and only immune globulin (Ig) available in prefilled syringes, offering those living with Primary Immunodeficiency (PI) or Chronic Inflammatory Demyelinating Polyneuropathy...
- Mar 27, 2023
The site will support CSL's growing R&D portfolio, accelerating the development of next-generation mRNA technology for vaccines WALTHAM, Mass., March 27, 2023 /PRNewswire/ -- Global biotechnology...
Mar 1, 2023CSL Seqirus and Amarin sign licensing agreement to commercialise Vazkepa (icosapent ethyl) in Australia and New Zealand
Melbourne, 1 March 2023 CSL Seqirus (Seqirus Pty Ltd) and Amarin Corporation plc (NASDAQ:AMRN) have today announced the signing of an exclusive license and distribution agreement to commercialise...
Mar 1, 2023
Significant reduction in number of attacks support the potential of once-monthly garadacimab as a prophylactic therapy for patients with hereditary angioedema KING OF PRUSSIA, Pa., March 1, 2023...
Feb 26, 2023CSL's Phase 3 Study Shows First-In-Class Garadacimab Provides Patients with Significant HAE Attack Prevention with Monthly Dosing
Majority of patients were attack free during the entire six-month treatment period (61.5%) Study results presented for first time at 2023 AAAAI Annual Meeting; global regulatory submissions...
Feb 23, 2023CSL's HOPE-B Data Published in the New England Journal of Medicine, Demonstrating Efficacy and Durability of HEMGENIX® (etranacogene dezaparvovec-drlb)
Data follow the historic approval of the first gene therapy for hemophilia B, which reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates...
- Feb 21, 2023
CSL recognized in Forbes and Statista's Best Large-sized Employer category for the fourth time since 2018. KING OF PRUSSIA, Pa., Feb. 21, 2023 /PRNewswire/ -- Global biotechnology leader CSL has...
Feb 20, 2023
HEMGENIX® underscores CSL's promise to deliver life-changing innovations that have the potential to help patients lead full lives MARBURG, Germany, Feb. 20, 2023 /PRNewswire/ -- Global...
Feb 6, 2023First targeted therapy available for the treatment of two main types of ANCA-associated vasculitis (AAV), a rare and systemic disease
First targeted therapy available for the treatment of two main types of ANCA-associated vasculitis (AAV), a rare and systemic disease
Dec 16, 2022CSL Receives Positive CHMP Opinion for Etranacogene Dezaparvovec – Gene Therapy for Adults with Hemophilia B
Global biotechnology leader CSL (ASX: CSL) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization (CMA) of etranacogene dezaparvovec.
Dec 14, 2022
Vifor Pharma AG ("Vifor") announced today that the Commercial Court St. Gallen has cancelled (kraftlos erklärt) all remaining publicly held registered shares of Vifor with a nominal value of CHF 0.01 each (each a "Vifor Share").
- Dec 12, 2022
Dr Paul McKenzie appointed Chief Executive Officer and Managing Director of CSL from 6 March 2023 MELBOURNE, Australia, Dec. 12, 2022 /PRNewswire/ -- The Board of Directors of CSL Limited...
Dec 12, 2022
CSL to access late-stage next-generation mRNA platform technology, enabling development of vaccines for COVID-19, influenza, multi-pathogen pandemic preparedness and other respiratory pathogens...
Dec 10, 2022CSL's Novel Gene Therapy HEMGENIX® (etranacogene dezaparvovec-drlb) Demonstrates Durable Protection and Sustained Factor IX Activity Levels for People Living with Hemophilia B at 24-Months Post-Treatment
Long-term data from the pivotal HOPE-B study show a one-time infusion of HEMGENIX generated elevated and sustained mean factor IX levels and reduced the rate of annual bleeding 24-month results...
Nov 28, 2022
China has the world’s largest iron deficiency anemia population with estimated prevalence of 15%1 Approval may also benefit the Chinese healthcare system, among others through implementation of...
Nov 25, 2022
Iron Deficiency Day unites a strong international coalition raising awareness on the serious health impact of iron deficiency and iron deficiency anemia1 This year, the focus is on importance of...
Nov 22, 2022U.S. Food and Drug Administration approves CSL's HEMGENIX® (etranacogene dezaparvovec-drlb), the first gene therapy for hemophilia B
Global biotechnology leader CSL (ASX: CSL) today announced that the U.S. Food and Drug Administration (FDA) approved HEMGENIX® (etranacogene dezaparvovec-drlb), the first and only one-time gene therapy for appropriate adults with hemophilia B.
Nov 3, 2022Cicada Innovations to operate new Melbourne-based biotech incubator to drive translation of world-class medical research
CSL, WEHI, and the University of Melbourne today announced the appointment of an independent operator to oversee and manage the new start-up incubator which will support and grow early-stage Australian biotech companies, providing both lab and office spaces.
Nov 2, 2022Next-Generation mRNA, Gene Therapy, Plasma Products, Monoclonal Antibodies, and Recent Acquisitions and Collaborations Highlight CSL R&D Day 2022
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...
Nov 1, 2022CSL Enters Licensing Agreement with Arcturus Therapeutics for Next Generation mRNA Vaccine Technology
CSL Limited (ASX:CSL; USOTC:CSLLY) today announces that its subsidiary, CSL Seqirus, has entered into a collaboration and license agreement with Arcturus Therapeutics Holdings Inc ("Arcturus...
Oct 26, 2022
Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY), today announced the company has entered into a Strategic Option and License Agreement with Arizona-based Translational Sciences for their enhanced thrombus dissolving drug candidate, TS23.
Oct 20, 2022
Vifor Pharma AG (Vifor) announced today that by decision dated October 19, 2022, SIX Exchange Regulation AG (SER) has approved an extension of the various exemptions from certain disclosure and publicity obligations granted by SER to Vifor Pharma AG previously (see Vifor Pharma AG's ad hoc announcement of August 2, 2022).
Oct 19, 2022
Global biotechnology leader CSL’s new global corporate headquarters has been awarded a five-star rating from the Green Building Council of Australia.
- Oct 13, 2022
Global biotherapeutics leader CSL today announced that two Australian scientists have each been awarded a CSL Centenary Fellowship of $1.25 million over five years.
Oct 12, 2022
Vifor Pharma AG (Vifor) announced today that Vifor has received approval for the delisting of the totality of Vifor's registered shares.
Oct 5, 2022CSL Announces Positive Preclinical Data for Self-Amplifying Messenger RNA (sa-mRNA) Influenza Vaccine Candidates
Data published in Molecular Therapy – Methods and Clinical Development confirm the potential preclinical benefit of the sa-mRNA technology platform, the next generation of mRNA vaccine technology
Sep 27, 2022
CSL Extends Reach of Global Research Acceleration Initiative with Freshly Inked Partnerships to Fast-Track Research Programs
Sep 26, 2022New Data at OPTIONS XI Conference Highlight Burden of Seasonal Influenza on Health Systems and the Need for Increased Vaccination Rates
CSL Seqirus, a business of CSL Limited (ASX:CSL), today announced new data highlighting the significant burden influenza places on hospitals and healthcare resource use, as well as on more...
Sep 26, 2022New Real-World Data Presented at OPTIONS XI Show Cell-Based and MF59®-Adjuvanted Influenza Vaccines Can Reduce the Burden of Seasonal Influenza on Hospitals and Health Systems
CSL Seqirus, a business of CSL Limited (ASX:CSL), today announced new data from four real-world studies showing the impact that cell-based and adjuvanted influenza vaccines can have in reducing...
Sep 26, 2022CSL Receives Manufacturing and Marketing Authorization in Japan for “Berinert® S.C. Injection 2000,” as a Medicine for prevention of Acute Hereditary Angioedema (HAE) attacks
CSL Behring K.K. (Head Office: Minato-ku, Tokyo; President and Representative Director: Jean-Marc Morange) announces that it has received a manufacturing and marketing approval from the Ministry of Health, Labour and Welfare for “Berinert® S.C. Injection 2000,” a lyophilized human C1-esterase inhibitor concentrate...
Sep 19, 2022
CSL applauds the United States District Court’s decision to issue a preliminary injunction preventing the United States Customs and Border Protection (CBP) from continuing to enforce its ban on plasma donations by Mexican nationals who enter the U.S. on a B-1/B-2 visa.
Sep 14, 2022
Bernadette Murdoch, an experienced Australian and global corporate affairs and communications leader across multiple industries, will join CSL and lead its global Reputation Management Center of...
- Sep 13, 2022
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...
Sep 13, 2022CSL Seqirus to Highlight Commitment to Influenza Protection with More than 20 Data Presentations at OPTIONS XI
CSL Seqirus, a part of CSL Limited (ASX:CSL), today announced new data will be presented at the Options for the Control of Influenza (OPTIONS XI) conference taking place September 26-29, 2022 in...
Sep 8, 2022Orphan Drug Designation granted for etranacogene dezaparvovec, CSL’s gene therapy for haemophilia B, by the Therapeutics Goods Administration
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
Aug 22, 2022CSL Vifor and Travere Therapeutics announce EMA has accepted for review the Conditional Marketing Authorization application for sparsentan for the treatment of IgA Nephropathy
A review decision by the European Medicines Agency (EMA) is expected in the second half of 2023 If approved, sparsentan will be a first-in-class treatment to address the significant unmet medical...
Aug 22, 2022
U.S. District Court for the District of Delaware rules Teva Pharmaceuticals infringes VFMCRP patent Disputes with all other Abbreviated New Drug Application (ANDA) filers regarding Velphoro® have...