Csl Ltd Stock Price, News & Analysis

The European Commission has granted conditional marketing authorization for HEMGENIX® (etranacogene dezaparvovec), marking it as the first one-time gene therapy for treating severe hemophilia B in adults. The therapy showed a 64% reduction in the adjusted annualized bleed rate in patients during clinical trials. Following the pivotal HOPE-B trial, 96% of patients discontinued routine Factor IX prophylaxis, with a 97% reduction in Factor IX consumption. The approval reflects CSL's commitment to innovation and improving the quality of life for hemophilia B patients.

Vifor Pharma AG has announced that the Commercial Court St. Gallen has legally canceled all publicly held registered shares of Vifor. The last trading day for these shares on the SIX Swiss Exchange is 22 December 2022, with the delisting date set for 23 December 2022. Shareholders of canceled shares will receive a cash compensation of USD 179.25 per share, with payment scheduled for 28 December 2022. This announcement emphasizes Vifor's transition and compensation framework for its investors.

CSL Limited has appointed Dr. Paul McKenzie as its new Chief Executive Officer and Managing Director effective March 6, 2023. McKenzie, currently the Chief Operating Officer, succeeds Paul Perreault, who will retire after 10 years in the role. McKenzie brings over 30 years of global biotechnology experience, having previously held positions at Biogen and major pharmaceutical companies. The transition aims to ensure sustainable growth and continues CSL's commitment to innovation and patient care as it executes its 2030 strategy.

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.