Csl Ltd - CSLLY STOCK NEWS

CSL has announced significant results from the Phase 3 VANGUARD study, published in The Lancet, demonstrating the efficacy of garadacimab (CSL312) as a once-monthly prophylactic treatment for hereditary angioedema (HAE). The study involved 39 patients treated with garadacimab, showing an 86.5% reduction in the monthly attack rate compared to placebo. Early protection was evident, with 75% of patients attack-free within 3 months. The safety profile was favorable, with common adverse events including upper respiratory infection. Regulatory submissions for garadacimab are anticipated later this year, reflecting CSL's commitment to innovative treatments for patients with HAE.

CSL (ASX:CSL; USOTC:CSLLY) presented pivotal Phase 3 VANGUARD trial results for garadacimab, a novel monoclonal antibody aimed at preventing attacks in patients with hereditary angioedema (HAE). During the six-month trial, 61.5% of patients on garadacimab experienced no attacks, while those on placebo had none. The monthly dosage led to an 86.5% mean attack rate reduction (p<0.001). Safety data indicated no treatment discontinuations due to adverse events. CSL plans regulatory submissions for garadacimab later this year, further signaling its commitment to developing innovative treatments for rare diseases.

CSL announced pivotal HOPE-B trial results for HEMGENIX® (etranacogene dezaparvovec-drlb), the first gene therapy approved for adult hemophilia B patients, showing significant long-term efficacy and safety. Published in NEJM, the trial demonstrated a 71% reduction in spontaneous bleeding episodes and a 78% reduction in joint bleeding episodes. Post-treatment, 96.3% of patients discontinued factor IX prophylaxis after 18 months, with infusions dropping from 72.5 to 2.5 annually. HEMGENIX® is now approved in the US and EU, showcasing CSL's commitment to innovative treatments for rare diseases.

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.