Csl Ltd - CSLLY STOCK NEWS

Seqirus, a CSL Limited business, presented an observational study at the IDSOG Meeting on July 30, 2021, revealing no unexpected adverse pregnancy outcomes among those vaccinated with the QIVc influenza vaccine during pregnancy. The study, involving 665 pregnant participants, showed no adverse fetal outcomes, supporting the vaccine's safety. QIVc, which uses a cell-based manufacturing process, is under FDA review for expanded age indications. Seqirus aims to enhance vaccine production capabilities with state-of-the-art facilities in the U.S. and plans for a new plant in Australia.

Seqirus has begun shipping its innovative seasonal influenza vaccines across the U.S. for the 2021/22 influenza season, aiming to meet record demand from the previous year. The company plans to supply approximately 60 million doses of vaccines, including FLUCELVAX^® QUADRIVALENT and FLUAD^® QUADRIVALENT, which cater to different age groups. The CDC recommends annual vaccination for those six months and older, emphasizing the importance of flu vaccinations amidst the ongoing COVID-19 pandemic.

Seqirus, a division of CSL Limited (ASX: CSL), co-authored a landmark study demonstrating the safety and efficacy of co-administering its seasonal influenza vaccine with Novavax's COVID-19 vaccine (NVX-CoV2373). Conducted in the UK, the Phase 3 trial involved 431 participants and found no additional safety concerns with the combination, suggesting potential for improved vaccine uptake. Despite promising results, limitations include a small sample size and lack of formal statistical assessments. The study aims to inform future vaccine guidelines as the influenza season approaches.

CSL Behring announced the approval of Hizentra for Medicare Part B coverage for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) effective July 18, 2021. This new coverage will reduce out-of-pocket expenses for patients, including costs for self-infusion pumps, supplies, and training. Previously covered under Medicare Part D, patients faced higher costs. The decision simplifies access for physicians as no prior authorization is needed, enhancing patient access to treatment options and aligning with CSL's commitment to improving patient care.

CSL Behring announced findings from a meta-analysis of seven Phase 3 trials involving over 82,000 patients with recent acute coronary syndrome (ACS). The analysis revealed that 49% of recurrent major adverse cardiovascular events (MACE) occurred within the first 90 days after an ACS event. The results highlight the criticality of this early period for high-risk patients. CSL Behring is advancing its Phase 3 AEGIS-II study to assess the efficacy of CSL112 in reducing MACE risk following heart attacks, aiming to enhance patient protection during this vulnerable timeframe.

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.