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CSL LTD SP/ADR (CSL) is a global biotechnology company known for its innovative therapies in iron deficiency and nephrology. Headquartered in St. Gallen, Switzerland, CSL Vifor, a division of CSL, focuses on strategic global partnerships, innovative pharmaceuticals, and precision healthcare solutions. Their portfolio includes Ferinject, an IV iron therapy with marketing authorization in 87 countries as of 2024, addressing iron deficiency anemia and heart failure in adults and pediatric patients. With a workforce of 32,000, CSL delivers life-saving products worldwide, striving to improve patients' quality of life.
Kapruvia® (difelikefalin) has received approval from the Swiss Agency for Therapeutic Products for treating chronic kidney disease (CKD)-associated pruritus in hemodialysis patients. This follows approvals from agencies in the U.S., Canada, and Europe. The approval is backed by positive results from pivotal phase-III trials, including KALM-1 and KALM-2, and 32 supportive studies. Regulatory decisions in Australia and Singapore are anticipated soon. The therapy aims to address a significant unmet medical need for those suffering from moderate-to-severe pruritus, potentially improving their quality of life.
Vifor Fresenius Medical Care Renal Pharma announces that NICE has recommended Tavneos® for treating severe granulomatosis polyangiitis (GPA) and microscopic polyangiitis (MPA) in adults in England, Wales, and Northern Ireland. This oral therapy follows MHRA authorization in May 2022. Clinical trials showed Tavneos® met primary endpoints, offering a new treatment option with a favorable safety profile. The launch is expected shortly, marking a significant advancement in addressing the unmet medical needs of AAV patients.
CSL announced positive top-line Phase 3 results for its investigational monoclonal antibody, garadacimab (CSL312), developed as a preventive treatment for hereditary angioedema (HAE). The study successfully met primary and secondary efficacy objectives, demonstrating favorable safety and tolerability. CSL plans to file for regulatory approvals by the end of the current fiscal year and will present full results at an upcoming scientific congress. Garadacimab targets Factor XIIa to inhibit HAE attack cascades, offering a potentially transformative therapy for patients with HAE.
CSL Limited (ASX: CSL) has outlined a set of ambitious targets aimed at reducing carbon emissions as part of its sustainability strategy. By 2030, CSL plans to cut 40% of its absolute Scope 1 & 2 emissions compared to average annual emissions from FY19-21. Additionally, the company aims to have suppliers responsible for 67% of Scope 3 emissions commit to similar reduction targets. Key strategies for emissions reduction include increasing energy efficiency and switching to renewable power sources.
CSL has announced a move to unify its brand by incorporating its name across all business units. This change aims to strengthen its identity as a single entity while maintaining the distinctiveness of CSL Behring and CSL Plasma. Seqirus will be rebranded to CSL Seqirus, and the recently acquired Vifor Pharma will be known as CSL Vifor. CEO Paul Perreault highlighted that this rebranding aligns with CSL's purpose-driven strategies and values, emphasizing patient focus and innovation. The company continues to serve over 100 countries with lifesaving therapies.
CSL Plasma has launched the Rika Plasma Donation System at its Aurora, Colorado location, marking the first of over 300 U.S. centers to adopt this advanced technology. The Rika system aims to reduce plasma collection time by approximately 30%, enhancing the overall donor experience. The design minimizes the volume of blood outside the donor's body, resulting in a more comfortable donation. The rollout is part of CSL Plasma's commitment to improve operational efficiency and meet the increasing demand for plasma-derived therapies.
CSL Limited has received all regulatory approvals for the acquisition of Vifor Pharma AG, with settlement set for 9 August 2022. CSL expects to acquire over 97% of Vifor shares post-settlement and plans to delist Vifor. Hervé Gisserot will become General Manager of Vifor upon settlement. CEO Paul Perreault emphasized the acquisition's strategic importance, enhancing CSL's capabilities in rare disease treatment. Vifor's CEO Abbas Hussain expressed confidence in the future within CSL's global framework, allowing for accelerated growth and product launches.
CSL Limited (ASX: CSL; USOTC: CSLLY) announced a further postponement of its public tender offer for all publicly held registered shares of Vifor Pharma Ltd. The settlement, originally set for July 22, 2022, is now extended until September 30, 2022, due to unmet offer conditions regarding merger clearances. This delay follows an initial postponement announced on March 28, 2022. Additionally, CSL has filed for the cancellation of the remaining publicly held Vifor shares.
Seqirus, part of CSL Limited, has commenced shipping its innovative influenza vaccine portfolio for the 2022/23 U.S. season. This includes the first cell-based quadrivalent vaccine, FLUCELVAX®, now available for ages six months and older, and the adjuvanted quadrivalent vaccine FLUAD®, which the CDC recommends for adults aged 65 and older. Seqirus aims to supply over 55 million doses, highlighting the importance of vaccination amidst potential flu resurgence. The CDC notes significant flu-related deaths and hospitalizations, emphasizing vaccination as crucial for public health.
On June 22, 2022, the CDC's ACIP recommended FLUAD® QUADRIVALENT as a preferential flu vaccine for adults 65 and older, emphasizing its clinical benefits over standard vaccines. This recommendation is based on extensive studies showing FLUAD's efficacy in enhancing immune responses, particularly in older populations at higher risk for influenza-related complications. With over 225 million doses distributed globally since its approval, FLUAD aims to protect vulnerable groups from severe illness during the upcoming influenza season.
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