CSL LTD SP/ADR - CSLLY STOCK NEWS

CSL announced significant findings from the 24-month follow-up of the pivotal HOPE-B study for HEMGENIX, the first gene therapy approved for hemophilia B. The treatment resulted in sustained mean factor IX activity levels (36.7 IU/dL) and a 64% reduction in bleeding rates (ABR) among participants. Safety data indicated no serious treatment-related adverse effects. With 94% of patients discontinuing prophylaxis, HEMGENIX shows promise for long-term efficacy and safety in hemophilia B treatment, highlighting CSL's commitment to innovative therapies.

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 $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.