CSL LTD SP/ADR - CSLLY STOCK NEWS

CSL Behring announced FDA approval for a 50mL prefilled syringe of Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) on April 18, 2023. Hizentra is the first immune globulin available in prefilled syringes, offering convenience for patients with Primary Immunodeficiency (PI) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The new size expands options for self-administration, decreasing treatment burden. Hizentra remains the most prescribed treatment for PI in the U.S. and is the only one approved for CIDP. Available in early 2024, the new syringe size joins existing 5mL, 10mL, and 20mL versions. CSL Behring aims to meet the anticipated demand for this innovative delivery method.

Tavneos^® has been newly incorporated in the 2022 EULAR recommendations for managing ANCA-associated vasculitis (AAV), according to a recent announcement by Vifor Fresenius Medical Care Renal Pharma. The recommendations highlight Tavneos^® as a key therapy option, emphasizing its ability to reduce glucocorticoid exposure and lower toxic effects while potentially enhancing renal function in GPA/MPA patients. The ADVOCATE study demonstrated that the Tavneos^® regimen surpassed prednisone in achieving sustained remission. This endorsement marks a significant step in enhancing patient care standards for AAV treatment, reflecting a commitment to reducing reliance on glucocorticoids.

CSL has officially opened a new state-of-the-art research and development (R&D) center in Waltham, Massachusetts, encompassing approximately 140,000 square feet, with 54,000 square feet dedicated to lab space, including the region's first biosafety level 3 laboratory. This facility will strengthen CSL's R&D capabilities in next-generation mRNA vaccine technology. The company plans to foster collaboration with local partners to enhance innovation. CSL's global R&D organization comprises over 2,000 employees across ten countries, reinforcing its commitment to developing life-saving therapies.

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.