CSL LTD SP/ADR - CSLLY STOCK NEWS

CSL Behring announced the closing of its global commercialization and license agreement with uniQure for etranacogene dezaparvovec (AMT-061), a novel gene therapy for hemophilia B. This agreement follows the completion of antitrust reviews and includes a $450 million upfront payment to uniQure, along with potential milestone payments and royalties. Etranacogene dezaparvovec aims to deliver near-normal levels of Factor IX for patients and could transform treatment for hemophilia B patients. Clinical trials show promise, with no serious treatment-related adverse events reported thus far.

On May 3, 2021, Seqirus announced promising Phase 3 clinical data showing its cell-based quadrivalent seasonal influenza vaccine (QIVc) is as safe and effective as the standard quadrivalent vaccine for children aged 6 months to <4 years during the 2019/20 flu season. Presented at the Pediatric Academic Society Virtual Annual Meeting, these findings support an FDA application for broader age use. The CDC emphasizes the high influenza risk in young children, underscoring the importance of vaccination as COVID-19 restrictions ease.

CSL Behring announced FDA approval for an updated label of Hizentra for treating Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The update simplifies dosage adjustments based on the PATH Extension study, which found that 90% of patients on the higher dosage remained relapse-free. This enhances treatment flexibility for physicians and patients. Hizentra is the most prescribed subcutaneous immune globulin therapy for CIDP, facilitating at-home self-infusions. CSL Behring continues to prioritize innovation in therapies for rare diseases.

Seqirus announced new real-world evidence published in Clinical Infectious Diseases showing that its MF59^® adjuvanted trivalent influenza vaccine (aTIV) provides greater effectiveness in reducing influenza-related medical encounters among adults 65+ compared to standard vaccines during the 2017/18 and 2018/19 seasons. The study analyzed data from 10.6 million vaccinated individuals, confirming aTIV's role in enhancing immune response for the elderly. Key findings underscore the importance of influenza vaccination for high-risk populations, despite low flu activity in the 2020/21 season due to COVID-19 measures.

Terumo Blood and Cell Technologies and CSL Plasma have announced a collaboration to develop a new plasma collection platform at CSL Plasma's U.S. collection centers. A clinical trial for the investigational plasmapheresis device commenced in April 2021. The introduction of this platform is contingent on U.S. FDA device clearance, with further details to follow. Plasma collected plays a crucial role in therapies for life-threatening conditions, including immune deficiencies and hemophilia. CSL Plasma operates over 300 centers globally, providing vital therapies to patients.

Seqirus has published new research in Vaccines showing that its cell-based quadrivalent influenza vaccine (QIVc) significantly reduced hospitalizations and emergency room visits compared to egg-based vaccines (QIVe) during the 2018/19 U.S. influenza season. Analysis indicated annual savings of $461 per vaccinated individual with QIVc. More than 20 million doses of QIVc were administered in the U.S., highlighting its public health impact. The study supports QIVc's effectiveness, especially against respiratory complications, while indicating potential cost benefits for healthcare systems.

Seqirus has received FDA approval for its FLUCELVAX® QUADRIVALENT influenza vaccine, expanding its use to individuals aged two and older, previously approved for those four and older. The approval is based on efficacy data showing a strong immune response in children aged ≥2 to <18 years during three influenza seasons. The vaccine, which incorporates a cell-based production process, aims to reduce strain mismatch and improve seasonal flu prevention. FLUCELVAX QUADRIVALENT will be available for the upcoming 2021/22 flu season, enhancing public health efforts amid ongoing pandemic challenges.

CSL Behring announced FDA approval for HAEGARDA® (C1 Esterase Inhibitor Subcutaneous) to prevent hereditary angioedema (HAE) attacks in patients aged 6 and older. HAE is a rare genetic disorder affecting about 1 in 50,000 people in the U.S. HAEGARDA, first approved in 2017, now offers a subcutaneous treatment option that reduces attack frequency by an average of 95%. The approval is based on successful results from the COMPACT trials, including safety data for pregnant women. This expands treatment options for pediatric patients, addressing unmet medical needs in the HAE community.