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CSL Ltd (CSLLY) is a global biotechnology leader developing lifesaving therapies and vaccines across its three core divisions. This page aggregates official announcements, financial disclosures, and strategic developments from the company.
Investors and industry professionals will find comprehensive coverage of earnings reports, regulatory milestones, and R&D breakthroughs. The curated collection includes updates on plasma-derived therapies, influenza vaccine production, and nephrology innovations through CSL Vifor.
All content undergoes strict verification to ensure alignment with financial disclosure standards. Users can expect timely updates on manufacturing expansions, clinical trial results, and global health partnerships that demonstrate CSL's market leadership.
Bookmark this page for direct access to CSL's verified corporate communications, presented in chronological order for efficient tracking of the company's progress in biotechnology and healthcare solutions.
CSL Vifor and Fresenius Kabi announced the approval of Ferinject® by China's National Medical Products Administration (NMPA) for treating iron deficiency in adults. This approval is significant given the high prevalence of iron deficiency anemia in China, affecting approximately 15% of the population. Ferinject® has marketing authorization in 85 countries and is expected to launch in H1 2023. The drug may enhance patient blood management in hospitals, as approximately 3-4 million patients undergo elective surgery annually.
The FDA has approved HEMGENIX (etranacogene dezaparvovec-drlb), the first one-time gene therapy for adults with hemophilia B, allowing eligible patients to produce their own factor IX. This treatment reduces the frequency of annual bleeding episodes and eliminates the need for prophylactic therapies. In the pivotal HOPE-B trial, 94% of patients discontinued factor IX prophylaxis post-treatment, with a 54% reduction in the annualized bleeding rate. HEMGENIX represents a significant advancement in hemophilia B treatment, enhancing patient outcomes with a single infusion.
CSL presented advancements in its R&D pipeline during its annual investor briefing. Key highlights include the priority review acceptance of etranacogene dezaparvovec for haemophilia B, and positive Phase III results for garadacimab, a treatment for hereditary angioedema. The company is also advancing projects in nephrology and influenza vaccines, including a collaboration with Arcturus Therapeutics for mRNA capabilities. CSL invested around $1.16 billion in R&D in fiscal 2021-2022. The newly appointed Cicada Innovations will operate a biotech incubator at CSL's Melbourne headquarters, supporting innovation-driven growth.
An agreement between Arcturus Therapeutics (NASDAQ: ARCT) and CSL Seqirus has been announced, positioning Arcturus for a potential financial boon. The collaboration includes an upfront payment of
Vifor Pharma AG announced a decision approved by SIX Exchange Regulation AG on October 19, 2022, extending exemptions from various disclosure and publicity obligations until February 28, 2023. This includes not publishing the Half-Year Report 2022 and other management disclosures, except notifications regarding the delisting date. These exemptions remain valid unless specific legal actions occur related to minority shareholders. If such events arise, the issuer's obligations would immediately revive.
SIX Exchange Regulation has approved the delisting of all registered shares of
CSL Plasma announced the opening of two new donation centers in Stockton and Hayward, California, increasing its presence to five locations in the state, with a sixth in Citrus Heights expected by summer 2023. CSL Plasma is a leading collector of plasma vital for producing therapies for various diseases. Each center contributes over $4 million annually to local economies and employs around 60 staff members. This expansion highlights CSL Plasma's commitment to meeting the growing demand for plasma-derived medicines, supporting local communities and job creation.
CSL Seqirus has been awarded a $30.1 million contract by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to manufacture and assess a cell-based influenza vaccine candidate for H5N8 virus. This marks the third award under a multi-year agreement, reinforcing the company's role in pandemic preparedness. A Phase 2 clinical study is anticipated to start in Q2 2023. The contract underscores CSL Seqirus' ongoing partnership with BARDA, aimed at bolstering public health responses to highly pathogenic avian influenza outbreaks.
CSL announced positive preclinical results for its self-amplifying mRNA (sa-mRNA) influenza vaccine candidates, showing a strong immune response against A(H5N1) and A(H1N1) strains. Published in Molecular Therapy – Methods and Clinical Development, the study indicated that a low dose (0.01 µg) of the A(H5N1) candidate induced significant antibody production and T-cell responses. CSL plans to initiate Phase 1 clinical trials soon, highlighting the sa-mRNA technology's potential to enhance vaccine efficacy and reduce doses required during pandemic settings.
CSL Seqirus presented significant data on influenza's impact on healthcare at the OPTIONS XI conference in Belfast from September 26-29, 2022. The WHO estimates up to 650,000 seasonal influenza deaths globally, with up to 52,000 deaths and 710,000 hospitalizations annually in the U.S. A study suggests raising U.S. vaccination rates from 45% to at least 70% to prevent overwhelming hospital systems during co-circulation with COVID-19. Another analysis in Italy showed an average of 8,892 influenza cases among 150,000 children under 14 each season, highlighting the disease's pediatric burden.