Welcome to our dedicated page for Csl news (Ticker: CSLLY), a resource for investors and traders seeking the latest updates and insights on Csl stock.
CSL Limited (CSLLY) regularly issues news about its biotechnology, biopharma and vaccine activities through its businesses CSL Behring, CSL Seqirus and CSL Vifor. Company announcements highlight regulatory milestones, clinical trial results and product updates across haemophilia, hereditary angioedema, influenza prevention, nephrology and other serious disease areas.
Recent news includes detailed Phase 3 data on HEMGENIX, a gene therapy for adults with hemophilia B, with five-year follow-up results from the HOPE-B trial describing factor IX activity, bleed rates and safety outcomes. CSL has also reported multiple regulatory approvals for ANDEMBRY, a factor XIIa-inhibiting monoclonal antibody used as a once-monthly prophylactic treatment to prevent hereditary angioedema attacks, including decisions by authorities in regions such as the European Union, Australia, the United Kingdom, Japan and the United States.
Through CSL Seqirus, the company publishes real-world evidence studies on cell-based quadrivalent influenza vaccines and their relative effectiveness compared with standard egg-based vaccines, as well as updates on influenza seasons and vaccine technologies. CSL and Arcturus Therapeutics have also announced European Commission marketing authorization for KOSTAIVE, described as the first self-amplifying mRNA COVID-19 vaccine approved in the European Union.
CSL Vifor news focuses on nephrology and iron deficiency, including regulatory and guideline developments for FILSPARI (sparsentan) in IgA nephropathy, such as European Commission decisions and guidance from organizations like England’s National Institute for Health and Care Excellence. Investors and observers following CSLLY news can use this page to review company communications on clinical evidence, regulatory approvals and product availability across CSL’s therapeutic portfolio.
CSL (CSLLY) has received European Commission approval for ANDEMBRY® (garadacimab), the first and only once-monthly treatment targeting factor XIIa for preventing hereditary angioedema (HAE) attacks in patients aged 12 and older. This marks the third regulatory approval for ANDEMBRY, following recent approvals in Australia and the UK.
The treatment comes with a patient-centric pre-filled pen for subcutaneous self-injection and works by inhibiting plasma protein factor XIIa. The approval is based on the Phase 3 VANGUARD trial and its open-label extension study, with results published in The Lancet (April 2023) and Allergy (October 2024).
HAE is a rare genetic disorder affecting approximately 1 in 50,000 people, characterized by recurrent and unpredictable attacks of angioedema. The treatment will be available following access and reimbursement negotiations, and is currently under review in the US, Japan, Switzerland, and Canada.
CSL Behring announced four-year results from the pivotal HOPE-B study of HEMGENIX, their gene therapy for hemophilia B. The data demonstrates sustained efficacy and safety through four years post-treatment. Key findings include:
- 94% of patients remained free of continuous factor IX prophylaxis
- Mean factor IX activity levels maintained at 37% through four years
- Approximately 90% reduction in mean adjusted annualized bleeding rate from lead-in to year four
- Joint bleeds reduced from 2.34 to 0.09 mean ABR
The Phase III HOPE-B trial involved 54 adult male participants with severe or moderately severe hemophilia B. No serious adverse events related to HEMGENIX were reported, with 96% of treatment-related adverse events occurring in the first six months. HEMGENIX, approved by FDA in 2022, is the first gene therapy for hemophilia B that can treat patients with and without AAV5 neutralizing antibodies.
CSL (ASX:CSL; USOTC:CSLLY) received a positive CHMP opinion recommending marketing authorization for garadacimab, a first-of-its-kind once-monthly treatment for hereditary angioedema (HAE) prevention in patients aged 12 and older. The treatment, which targets factor XIIa to prevent HAE attacks, demonstrated impressive results in the Phase 3 VANGUARD trial, with 62% of patients achieving attack-free status and an 86.5% reduction in mean monthly HAE attacks compared to placebo.
The European Commission's final decision is expected in Q1 2025. The recommendation is supported by favorable long-term safety data from an ongoing open-label extension study, with median exposure of 13.8 months. If approved, garadacimab would be available across all EU member states.
CSL Behring, a global leader in biotherapeutics, has significantly scaled its healthcare professional (HCP) engagement program using the ON24 platform. Leveraging ON24's intelligent engagement solutions, CSL Behring has enhanced its digital engagement, resulting in new potential customers and better insights into customer content engagement. The integration with Veeva CRM allows real-time data capture and analysis, informing follow-up strategies and deepening customer relationships. Before partnering with ON24, CSL Behring faced challenges with disjointed digital tools and manual processes that hindered scalability. Now, the company offers consistent, meaningful content to HCPs globally through live and on-demand webinars, reaching thousands of HCPs and increasing engagement. This transformation has enabled CSL Behring to expand its reach without adding headcount, repurposing content across 40 countries. The life sciences industry saw a 13% year-over-year increase in digital experiences in 2023, emphasizing the sector's shift towards omnichannel strategies.
CSL Vifor and Travere Therapeutics announced that Swissmedic has granted temporary marketing authorization for FILSPARI (sparsentan) to treat adults with primary IgA nephropathy (IgAN) with specific urine protein levels. The approval is based on the phase-III PROTECT trial results. This follows full marketing approval by the FDA in September 2024 and conditional marketing authorization by the EMA in April 2024.
Emmanuelle Lecomte Brisset of CSL highlighted the high unmet medical need for targeted IgAN therapy. Eric Dube of Travere Therapeutics emphasized FILSPARI's benefits as a non-immunosuppressive, once-daily oral treatment that can provide superior results compared to maximally dosed irbesartan.
CSL Seqirus presented five studies at IDWeek 2024, emphasizing the need to increase influenza vaccination rates and showcasing the benefits of cell-based influenza vaccines. Key findings include:
1. A dynamic model showed that increasing vaccination rates to at least 45% is necessary to avoid hospital system resource saturation, especially in ICUs.
2. Multiple real-world evidence studies demonstrated improved relative vaccine effectiveness of cell-based vaccines compared to egg-based vaccines across different age groups, including children as young as 6 months.
3. A model based on the 2022-23 flu season estimated that cell-based vaccines would have averted a significant burden of influenza-related illnesses compared to egg-based vaccines.
4. Cell-based vaccines were found to be cost-saving compared to recombinant influenza vaccines for adults aged 18-64.
CSL Seqirus, a global leader in pandemic preparedness, has received a $34 million award from the Biomedical Advanced Research and Development Authority (BARDA) to complete the fill and finish process for additional pre-pandemic vaccines. This marks the sixth avian influenza pandemic preparedness award from BARDA to CSL Seqirus. The company will deliver approximately 3 million finished doses of MF59®-adjuvanted H5N1 pre-pandemic vaccine and manufacture an additional lot of H5N8 antigen.
CSL Seqirus' manufacturing facility in Holly Springs, North Carolina, is the largest cell-based influenza vaccine producer in the world. It can deliver 150 million influenza vaccine doses within six months of a pandemic declaration. This project is supported by federal funds from the Department of Health and Human Services, Administration for Strategic Preparedness and Response, and BARDA.
CSL Seqirus presented real-world evidence (RWE) studies at OPTIONS XII, showcasing the effectiveness of influenza vaccinations. Key findings include:
1. Cell-based vaccines showed improved relative vaccine effectiveness (rVE) compared to egg-based vaccines across different age groups, including children as young as six months.
2. A 2023/24 season study revealed cell-based vaccine effectiveness was highest in children 6 months to 3 years at 88% against laboratory-confirmed influenza.
3. MF59® adjuvanted quadrivalent vaccine showed comparability to high-dose quadrivalent vaccine in preventing flu-related ER visits and hospitalizations for adults 65+.
These studies highlight CSL Seqirus' commitment to evaluating vaccine effectiveness through RWE, complementing randomized controlled trials and providing ongoing insights into real-world outcomes.
CSL and Arcturus Therapeutics announced results from a head-to-head study showing their self-amplifying mRNA (sa-mRNA) COVID-19 vaccine ARCT-154 maintained superior immunogenicity compared to Comirnaty® for up to one year. The study, presented at the OPTIONS XII conference, demonstrated:
1. Higher antibody levels against multiple SARS-CoV-2 strains, including Wuhan-Hu-1 and Omicron variants.
2. Effectiveness at one-sixth the dose of Comirnaty® (5 μg vs 30 μg).
3. Superior durability of immune response in both younger and older adults.
Additionally, their bivalent vaccine ARCT-2301 showed superior immunogenicity over Comirnaty® bivalent vaccine up to six months post-vaccination. The sa-mRNA platform vaccine targeting the JN.1 variant is now approved in Japan under the name KOSTAIVE®.
CSL (CSLLY) and Arcturus Therapeutics announced results from a head-to-head study showing their self-amplifying mRNA (sa-mRNA) COVID-19 vaccine maintained superior immunogenicity compared to Comirnaty® for up to one year. The study, presented at the OPTIONS XII conference, demonstrated ARCT-154 elicited superior antibody persistence against multiple SARS-CoV-2 strains at one-sixth the dose of Comirnaty®.
Key findings include:
- ARCT-154 showed superior neutralizing antibodies against Wuhan-Hu-1 strain at Day 361
- Similar advantages were observed against Omicron BA.4-5 and other variants
- A bivalent formula, ARCT-2301, also demonstrated superior immunogenicity over Comirnaty®
The sa-mRNA COVID-19 vaccine is approved in Japan under the name KOSTAIVE® for adults 18 and older.
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