Csl Ltd - CSLLY STOCK NEWS

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 $200 million and potential total payments exceeding $4 billion for development and commercialization milestones. Arcturus will hold a 40% profit sharing for COVID-19 vaccines and receive double-digit royalties on flu and other respiratory vaccines. This partnership leverages Arcturus’ self-amplifying mRNA technology and CSL's extensive manufacturing capabilities.

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 Vifor Pharma AG, following a court decision regarding the cancellation of the publicly held shares. This delisting, which Vifor applied for on August 18, 2022, will take effect after determining the final trading day in consultation with Vifor. Each share has a par value of CHF 0.01. The delisting reflects significant regulatory changes affecting the company's public trading status.

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.

CSL Seqirus announced findings from four real-world studies presented at OPTIONS XI, demonstrating the effectiveness of cell-based and adjuvanted influenza vaccines in reducing influenza-related hospitalizations and costs. Notably, data showed that the MF59-adjuvanted FLUAD vaccine decreased hospitalizations in adults aged 65 and older, while the FLUCELVAX QUADRIVALENT vaccine was more effective for adults aged 18 to 64. The predictive modeling indicated potential savings of 24,000 acute hospital beds during high flu seasons, emphasizing the importance of vaccination rates to avoid healthcare resource saturation.