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European Commission Approves CSL and Arcturus Therapeutics' KOSTAIVE®, the First Self-amplifying mRNA COVID-19 Vaccine
Prnewswire· 2025-02-14 13:30
- KOSTAIVE represents a significant advancement in vaccine technology, demonstrating superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trialsWALTHAM, Mass. and SAN DIEGO, Feb. 14, 2025 /PRNewswire/ -- Global biotechnology leader CSL (ASX: CSL; USOTC: CSLLY) and sa-mRNA pioneer Arcturus Therapeutics (Nasdaq: ARCT) today announced that the European Commission has granted marketing authorization for KOSTAIVE ® (ARCT ...
CSL(CSLLY) - 2025 Q2 - Earnings Call Presentation
2025-02-11 13:26
Fiona Mead Company Secretary For further information, please contact: Investors Media Chris Cooper Investor Relations CSL Limited P: +61 455 022 740 E: chris.cooper@csl.com.au For immediate release 11 February 2025 Results Presentation for the Half-year ended 31 December 2024 Melbourne, Australia – CSL (ASX:CSL; USOTC:CSLLY) Please find attached the slides for the presentation on the half year results that will be given by the Chief Executive Officer and the Chief Financial Officer shortly. The briefing wil ...
CSL(CSLLY) - 2025 Q2 - Earnings Call Transcript
2025-02-11 13:25
CSL Limited (OTCQX:CSLLY) Q2 2025 Results Earnings Conference Call February 10, 2025 7:00 PM ET Company Participants Chris Cooper - Vice President and Head of Investor Relations Paul McKenzie - Chief Executive Officer and Managing Director John Levy - Interim Chief Financial Officer Joy Linton - Interim Executive Vice President, CSL Behring Dave Ross - Senior Vice President and General Manager, CSL Seqirus Hervé Gisserot - Senior Vice President and General Manager, CSL Vifor Conference Call Participants Lya ...
uniQure/ CSL Behring's Hemophilia Gene Therapy Shows Sustained Efficacy and Safety At Four Years
Benzinga· 2025-02-07 18:04
CSL Limited CSLLY and uniQure Inc QURE announced the four-year results from the pivotal HOPE-B study confirming the long-term durability and safety of a one-time infusion of Hemgenix (etranacogene dezaparvovec-drlb) for adults hemophilia B patients.The data showed that through four years, Hemgenix continues to deliver elevated and sustained factor IX activity levels, can offer long-term and greater bleed protection compared to prophylactic treatment, can eliminate the need for routine factor IX prophylaxis, ...
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
Prnewswire· 2025-02-07 14:12
94 percent of patients eliminated factor IX prophylaxis and remained free of continuous prophylaxis through four years post-treatment Mean factor IX activity levels were sustained at near normal levels of 37% through four years post-treatment, reinforcing the efficacy of HEMGENIX in the treatment of hemophilia B Phase 3 HOPE-B data showed that a one-time treatment with HEMGENIX provided long-term bleed protection as mean adjusted annualized bleeding rate (ABR) for all bleeds was reduced by approximately 90 ...
New Data Presented at IDWeek 2024 Show Adjuvanted and High-Dose Influenza Vaccines are Comparable in Protecting Adults 65 Years of Age and Older Against Seasonal Influenza
Prnewswire· 2024-10-18 12:30
Results of the first season of a randomized study showed adjuvanted and high-dose influenza vaccines did not differ in effectiveness against PCR-confirmed influenza. This is the first randomized study to evaluate the relative vaccine effectiveness of adjuvanted influenza vaccines compared to high-dose influenza vaccines for prevention of lab-confirmed influenza. SUMMIT, N.J., Oct. 18, 2024 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX: CSL), today announced the first season (2023-2024 influenza season ...
Travere Therapeutics and CSL Vifor Announce Swissmedic Approval of FILSPARI® (sparsentan) for the Treatment of IgA Nephropathy
GlobeNewswire News Room· 2024-10-17 11:01
SAN DIEGO, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) and CSL Vifor today announced that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). "FILSPARI targets damage directly in the kidney and offers patients a convenient, once daily, oral, nonimmunosuppressive treatment that can provide superior result ...
CSL Vifor and Travere Therapeutics Announce Swissmedic approval of FILSPARI® (sparsentan) for the treatment of IgA Nephropathy
Prnewswire· 2024-10-17 06:30
Temporary marketing authorization is based on statistically significant and clinically meaningful results from the phase-III PROTECT trial ST. GALLEN, Switzerland and SAN DIEGO, Oct. 17, 2024 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). ...
CSL Seqirus Presents Data at IDWeek 2024 Highlighting the Urgent Need to Increase Influenza Vaccination Rates and the Benefits of Cell-Based Influenza Vaccines
Prnewswire· 2024-10-16 13:00
Analysis from a dynamic model showed the need to increase influenza vaccination rates in the U.S. to at least 45% to avoid saturation of hospital system resources, particularly in intensive care units (ICUs).1 Results from multiple real-world evidence (RWE) studies over different seasons showed improved relative vaccine effectiveness (rVE) of cell-based vaccines compared with egg-based vaccines in preventing outpatient test-confirmed influenza across different age groups, including as young as 6 months.2,3 ...
CSL Seqirus, a Global Leader in Pandemic Preparedness, Announces Sixth BARDA Award in Response to Avian Influenza
Prnewswire· 2024-10-04 16:30
CSL Seqirus has received a Biomedical Advanced Research and Development Authority (BARDA) award to complete the fill and finish process for additional pre-pandemic vaccines to further support the U.S. government's outbreak and preparedness response. BARDA has requested adjuvanted H5N1 pre-pandemic vaccines and additional H5N8 antigen as part of its decision to expand its portfolio of pre-pandemic vaccines. This $34 million investment is the sixth avian influenza pandemic preparedness award made to CSL Seqir ...