News for CSLLY Stock

CSL Vifor and Travere Therapeutics announce standard EU approval for FILSPARI® in IgA Nephropathy CSL Receives Approval in Japan for ANDEMBRY® (garadacimab) Subcutaneous (S.C.) Injection 200mg Pens, a Novel Human Anti-Activated Factor XII Monoclonal Antibody for the Prevention of Acute Attacks of Hereditary Angioedema (HAE) European Commission Approves CSL and Arcturus Therapeutics' KOSTAIVE®, the First Self-amplifying mRNA COVID-19 Vaccine European Commission Approves CSL and Arcturus Therapeutics’ KOSTAIVE®, the First Self-amplifying mRNA COVID-19 Vaccine European Commission Approves CSL's ANDEMBRY® (garadacimab) for the Prevention of Recurrent Attacks of Hereditary Angioedema (HAE) CSL Behring's Gene Therapy HEMGENIX® (etranacogene dezaparvovec-drlb) Four Years Post-Infusion Data Continue to Show Sustained Efficacy and Safety in Adults with Hemophilia B CSL Receives Positive CHMP Opinion for Garadacimab in Hereditary Angioedema (HAE) CSL Behring Scales Global HCP Engagement and Attracts new HCPs with the ON24 Platform CSL Vifor and Travere Therapeutics Announce Swissmedic approval of FILSPARI® (sparsentan) for the treatment of IgA Nephropathy CSL Seqirus Presents Data at IDWeek 2024 Highlighting the Urgent Need to Increase Influenza Vaccination Rates and the Benefits of Cell-Based Influenza Vaccines CSL Seqirus, a Global Leader in Pandemic Preparedness, Announces Sixth BARDA Award in Response to Avian Influenza CSL Seqirus Presents Real-World Evidence at OPTIONS XII Conference Highlighting Effectiveness of Influenza Vaccinations Self-Amplifying mRNA COVID-19 Vaccine Demonstrates Superior Immune Response Compared with mRNA Vaccine at 12 Months Post-Vaccination Self-Amplifying mRNA COVID-19 Vaccine Demonstrates Superior Immune Response Compared with mRNA Vaccine at 12 Months Post-Vaccination CSL Seqirus, a Global Leader in Pandemic Preparedness, Announces Fifth BARDA Award in Response to Avian Influenza Outbreak Veltassa® (patiromer) approved in Japan for the treatment of adults with hyperkalemia Japan's Ministry of Health, Labor and Welfare Approves CSL and Arcturus Therapeutics' Updated Self-amplifying mRNA COVID-19 Vaccine for Protection against JN.1 Strain, to be Distributed in Japan by Meiji Seika Pharma Japan’s Ministry of Health, Labor and Welfare Approves CSL and Arcturus Therapeutics’ Updated Self-amplifying mRNA COVID-19 Vaccine for Protection against JN.1 Strain, to be Distributed in Japan by Meiji Seika Pharma CSL Seqirus Begins Shipping Its Portfolio of Influenza Vaccines for the 2024/25 Flu Season CSL Seqirus, a Proud Champion of Pandemic Preparedness, Announces U.S. Government Award in Response to Avian Influenza Nature Communications Publishes Pivotal Data Demonstrating Efficacy and Tolerability of CSL and Arcturus Therapeutics' COVID-19 Vaccine Nature Communications Publishes Pivotal Data Demonstrating Efficacy and Tolerability of CSL and Arcturus Therapeutics’ COVID-19 Vaccine Recently Published Real-World Evidence Study Shows Effectiveness of Cell-Based Quadrivalent Influenza Vaccine Over Three Seasons CSL Vifor and Travere Therapeutics Announce European Commission approves FILSPARI® (sparsentan) for the treatment of IgA Nephropathy Ferinject® approved by Health Canada for the treatment of iron deficiency anemia in adult and pediatric patients and iron deficiency in adult patients with heart failure CSL Seqirus is Fully Prepared to Implement the FDA's Vaccines and Related Biological Products Advisory Committee Trivalent Influenza Vaccines Strain Selection for the 2024/25 U.S. Season Half year reported NPATA US$2 billion¹,² Up 13% at constant currency³ CSL Announces Top-line Results from the Phase 3 AEGIS-II Trial Evaluating the Efficacy and Safety of CSL112 (apolipoprotein A-I [human]) New COVID-19 sa-mRNA Results from CSL and Arcturus Therapeutics Demonstrate Longer Duration of Immunity Compared to Conventional COVID-19 mRNA Vaccine Booster New COVID-19 sa-mRNA Results from CSL and Arcturus Therapeutics Demonstrate Longer Duration of Immunity Compared to Conventional COVID-19 mRNA Vaccine Booster Harris Poll Survey Finds People Receiving Treatment for CIDP Are Interested in Exploring More Convenient Treatment Options CSL Behring Announces Availability of Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) 10g Prefilled Syringe CSL and Arcturus Therapeutics' ARCT-154 Demonstrates Non-Inferiority to Original Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster CSL and Arcturus Therapeutics’ ARCT-154 Demonstrates Non-Inferiority to Original Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster CSL's Garadacimab, a First-in-Class Factor XIIa Inhibitor, Receives FDA and EMA Filing Acceptance CSL Behring's HEMGENIX® (etranacogene dezaparvovec-drlb) Demonstrates at Three Years Post-Treatment Long-Term Durability, Safety and Greater Bleed Protection Versus Prophylactic Treatment in People Living with Hemophilia B Japan's Ministry of Health, Labour and Welfare Approves CSL and Arcturus Therapeutics' ARCT-154, the first Self-Amplifying mRNA vaccine approved for COVID in adults Japan's Ministry of Health, Labour and Welfare Approves CSL and Arcturus Therapeutics’ ARCT-154, the First Self-Amplifying mRNA Vaccine Approved for COVID in Adults Iron Deficiency Day 2023: CSL Vifor calls for access to iron deficiency diagnosis and treatment CSL and uniQure Win 2023 Prix Galien USA Award New Data Presented at IDWeek 2023 Demonstrates Public Health Benefit and Cost Savings Associated with Cell-Based and Adjuvanted Influenza Vaccines CSL Seqirus Presents Real-World Evidence at ESWI Demonstrating the Impact of Influenza Vaccination Campaigns to Help Protect People and Healthcare Systems CSL Seqirus Announces Third U.S. Government Award in Relation to Influenza A(H5N8) Candidate Vaccine Ferinject® granted upgraded recommendations in 2023 ESC heart failure guidelines CSL Appoints Jeffrey Ball as First Chief Sustainability Officer CSL Seqirus Begins Shipping Portfolio of Innovative Influenza Vaccines for the 2023/24 U.S. Season CSL Behring Announces the First Patient Has Received FDA-Approved HEMGENIX® (etranacogene dezaparvovec-drlb) for Hemophilia B Injectafer® approved in the U.S. for the treatment of iron deficiency in patients with heart failure Topline Results from Two-Year Primary Efficacy Endpoint in Pivotal Phase 3 DUPLEX Study of Sparsentan in Focal Segmental Glomerulosclerosis CSL Behring Receives FDA Approval for Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) 50mL Prefilled Syringe Tavneos® (avacopan) included in updated EULAR recommendations for the management of AAV CSL Opens New, State-of-the-Art Vaccine Research and Development Facility in Waltham, Massachusetts The Lancet Publishes Pivotal Phase 3 Data on CSL's First-in-Class Garadacimab for HAE CSL's Phase 3 Study Shows First-In-Class Garadacimab Provides Patients with Significant HAE Attack Prevention with Monthly Dosing CSL's HOPE-B Data Published in the New England Journal of Medicine, Demonstrating Efficacy and Durability of HEMGENIX® (etranacogene dezaparvovec-drlb) Biotech Leader CSL Again Named Among America's Best Employers by Forbes First Gene Therapy for Hemophilia B, CSL's HEMGENIX®, Approved by the European Commission Cancellation of remaining publicly held registered shares of Vifor Pharma AG CSL Announces Next CEO & Managing Director CSL'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 Ferinject® approved in Chinafor the treatment of iron deficiency in adult patients U.S. Food and Drug Administration approves CSL's HEMGENIX® (etranacogene dezaparvovec-drlb), the first gene therapy for hemophilia B Next-Generation mRNA, Gene Therapy, Plasma Products, Monoclonal Antibodies, and Recent Acquisitions and Collaborations Highlight CSL R&D Day 2022 Arcturus Announces Collaboration with CSL to Develop and Commercialize Self-amplifying mRNA Vaccines Approval of extension of exemptions from SIX disclosure and publicity obligations Approval of delisting of Vifor Pharma AG's registered shares CSL Plasma Expands in California with New Donation Centers to Collect Life-Saving Plasma CSL Seqirus Announces U.S. Government Award to Manufacture and Clinically Assess Influenza A(H5N8) Pre-Pandemic Vaccine CSL Announces Positive Preclinical Data for Self-Amplifying Messenger RNA (sa-mRNA) Influenza Vaccine Candidates New Data at OPTIONS XI Conference Highlight Burden of Seasonal Influenza on Health Systems and the Need for Increased Vaccination Rates New 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 presents new research and development center in Marburg, Germany CSL Seqirus to Highlight Commitment to Influenza Protection with More than 20 Data Presentations at OPTIONS XI CSL Plasma Provides Free Flu Vaccines to U.S. Plasma Donors CSL Vifor and Travere Therapeutics announce EMA has accepted for review the Conditional Marketing Authorization application for sparsentan for the treatment of IgA Nephropathy VFMCRP announces U.S. Court upholds validity of Velphoro® patent Kapruvia® approved in Switzerland with additional regulatory decisions expected in H2 2022 Tavneos® (avacopan) recommended by England’s NICE for the treatment of AAV (GPA/MPA) CSL Announces Positive Top-Line Phase 3 Results for Garadacimab as Preventive Treatment in Patients with Hereditary Angioedema (HAE) CSL announces carbon emissions reduction targets CSL LAUNCHES NEW UNIFIED GLOBAL BRAND IDENTITY CSL Plasma Reimagines Donor Experience With First Donations Completed on Innovative Plasma Collection Technology Finalization of Vifor Pharma acquisition Extension of the postponement of the settlement of Vifor Pharma tender offer Seqirus Begins Shipping Portfolio of Innovative Influenza Vaccines for the 2022/23 U.S. Season CDC Advisory Committee Includes FLUAD® QUADRIVALENT as a Preferentially Recommended Influenza Vaccine for Adults 65 and Older 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 Seqirus Completes $156 Million Expansion to Holly Springs Manufacturing Facility, Optimizing Global Manufacturing Capabilities for Seasonal and Pandemic Influenza Vaccines Seqirus' Holly Springs Manufacturing Facility Designated by U.S. Government as Pandemic Ready FDA Accepts CSL Behring's Biologics License Application for Etranacogene Dezaparvovec for Priority Review Update on the timeline for Vifor Pharma tender offer Walter Charles Named Senior Vice President and General Manager of CSL Plasma 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 European Medicines Agency Commences Review of Novel Gene Therapy Candidate Etranacogene Dezaparvovec for People with Hemophilia B Publication of definitive end result for Vifor Pharma tender offer Publication of provisional end result for Vifor Pharma tender offer: Participation rate of 94 percent Publication of definitive Interim Result for Vifor Pharma tender offer: CSL Behring AG declares offer successful Publication of provisional interim result for Vifor Pharma tender offer: Participation rate of 74 percent Forbes Magazine Ranks Global Biotech Leader CSL Among America's Best Employers for 2022 Seqirus and U.S. Government Renew Multi-Year Agreement for Influenza Pandemic Preparedness and Response CSL Plasma Makes $125,000 Donation to American Red Cross for Disaster Relief in U.S. Communities Seqirus, a Business of CSL Limited, Announces New Facility Supporting Research & Development of Leading-Edge Influenza Vaccine Technology 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 CSL BEHRING AG PUBLISHES OFFER PROSPECTUS ON PUBLIC TENDER OFFER FOR ALL PUBLICLY HELD SHARES OF VIFOR PHARMA LTD. CSL Behring AG publishes Offer Prospectus on public tender offer for all publicly held shares of Vifor Pharma Ltd. CSL Behring Receives Accelerated CHMP Assessment for Etranacogene Dezaparvovec for European Patients Living with Hemophilia B EMA Grants Accelerated Assessment for CSL Behring's Haemophilia B Gene Therapy CSL Limited announces tender offer to acquire Vifor Pharma Ltd New Data Supports the Effectiveness of Adjuvanted Seasonal Influenza Vaccine in Reducing Influenza-Related Hospitalizations and Healthcare Costs in Older Adults Seqirus Announces U.S. FDA Approval for Multi-Dose Vial Presentation of First-Ever Adjuvanted, Cell-Based Pandemic Influenza Vaccine CSL Plasma Opens 300th Plasma Donation Center in United States Seqirus Presents New Real-World Evidence Supporting Effectiveness of Differentiated Seasonal Influenza Vaccine Technologies at ISIRV-WHO Virtual Conference 2021 Clinical Trial Milestones, Investments in aQIVc and sa-mRNA Influenza Vaccines and New Strategic Collaborations Among the Highlights from CSL R&D Day Seqirus Receives FDA Approval of its Cell-Based Quadrivalent Influenza Vaccine, Expanding the Age Indication to Include Children as Young as Six Months The New England Journal of Medicine Publishes First-of-its-Kind Study on Cell-Based Quadrivalent Seasonal Influenza Vaccine (QIVc) Efficacy in Children and Adolescents ≥2 to <18 Years of Age Seqirus Awarded U.S. Government Contract to Develop Two Pandemic Influenza Vaccines Seqirus Presents New Real-World Evidence Demonstrating Effectiveness of Cell-Based and Adjuvanted Seasonal Influenza Vaccines at IDWeek 2021 Urban League of Philadelphia Names CSL's Elizabeth Walker to Board of Directors CSL Plasma to Provide Flu Vaccines to U.S. Plasma Donors Seqirus Announces Investment in Next-Generation Influenza Vaccine Technology, Self-Amplifying Messenger RNA (sa-mRNA) The European Academy of Neurology (EAN) and Peripheral Nerve Society (PNS) Task Force Has Strongly Recommended Subcutaneous Immunoglobulin (SCIg) for CIDP Maintenance Treatment FDA Approves New BERINERT® (C1 Esterase Inhibitor, Human (Intravenous)) Administration Kit for Increased Patient Convenience Seqirus Presents New Safety Data Demonstrating Safety of Cell-Based Seasonal Influenza Vaccine on Pregnancy Outcomes Seqirus Begins Shipping Portfolio of Innovative Vaccines for the 2021/22 U.S. Influenza Season Seqirus Co-Authors First Study to Assess Simultaneous Administration of Seasonal Influenza Vaccine and COVID-19 Vaccine Candidate 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 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 Lyfebulb and CSL Behring Announce the Winner of the 2021 Transplant Innovation Challenge CSL Behring Announces Closing of Global Commercialization and License Agreement with uniQure for etranacogene dezaparvovec Seqirus Presents New Phase 3 Clinical Data Supporting Use of Cell-Based Seasonal Influenza Vaccine in Children Six Months Through <4 Years of Age Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) Label Update Provides New Dosing Guidelines for Physicians, Allowing for Greater Flexibility in Treating CIDP Patients Seqirus Publishes New Real-World Evidence Supporting the Effectiveness of Adjuvanted Seasonal Influenza Vaccine in Adults 65 Years and Older in Clinical Infectious Diseases Terumo Blood and Cell Technologies and CSL Plasma Announce Collaboration to Deliver New Plasma Collection Platform Seqirus Announces U.S. FDA Approval of Expanded Age Indication of Its Cell-Based Quadrivalent Influenza Vaccine for People Two Years of Age and Older New Seqirus Data Published in Vaccines Highlight Effectiveness and Economic Benefit of Cell-Based Quadrivalent Seasonal Influenza Vaccine (QIVc) in the 2018/19 U.S. Influenza Season Seqirus Real World Evidence Published in Vaccine Highlights Value of Cell-Based Quadrivalent Influenza Vaccine in Preventing Influenza Related Hospitalizations in the U.S. 2017/18 Season U.S. Food and Drug Administration Approves HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) for Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Patients Seqirus Publishes New Real-World Evidence (RWE) on Relative Effectiveness of Adjuvanted Seasonal Influenza Vaccine in Adults 65 Years and Older in Vaccines