Csl Ltd - CSLLY STOCK NEWS

CSL Limited (ASX:CSL; USOTC:CSLLY) reported significant advancements during its R&D investment briefing on Oct. 18, 2021. The company announced a phase 3 study for a 4-Factor Prothrombin Complex Concentrate to address traumatic injury, and successfully enrolled patients ahead of schedule in its VANGUARD Phase 3 trial for Garadacimab. Over $1 billion was invested in R&D, marking a milestone in company history. The Seqirus division is progressing mRNA and adjuvanted influenza vaccines, while a new partnership with the Walter and Eliza Hall Institute aims to enhance biologic therapies development.

Seqirus has received FDA approval for FLUCELVAX QUADRIVALENT, allowing its use for children as young as six months. This is the first cell-based influenza vaccine in the U.S. and now eligible for all age groups. The approval is based on a Phase 3 clinical study demonstrating safety comparable to standard vaccines in young children. FLUCELVAX QUADRIVALENT can offer better effectiveness due to its manufacturing process, which avoids egg-adapted changes. Seqirus aims to enhance vaccine accessibility and effectiveness, addressing potential risks in upcoming flu seasons.

Seqirus, part of CSL Limited, announced the publication of efficacy data for its cell-based quadrivalent influenza vaccine (QIVc) in The New England Journal of Medicine. The randomized controlled trial demonstrated an efficacy of 54.6% in children aged 2 to < 18 years across three seasons and eight countries. This study marks the first absolute efficacy assessment for a cell-based influenza vaccine in young children. The FDA has approved QIVc for children ≥2 years and is reviewing its use for those aged six months. This vaccine manufacturing process aims to enhance effectiveness and expedite production during pandemics.

Seqirus has been awarded a $34.95 million contract by BARDA to develop two influenza A(H2Nx) virus vaccine candidates. The agreement aims to evaluate the safety and immunogenicity of these candidates in a Phase 1 clinical study, with the objective of enhancing pandemic preparedness. Seqirus will utilize its advanced cell-based and self-amplifying mRNA technologies. This contract strengthens Seqirus' longstanding partnership with BARDA and supports its role as a leader in pandemic influenza preparedness, addressing the potential threat of influenza viruses that have no current human strains.

Seqirus announced promising data on the effectiveness of its cell-based and adjuvanted seasonal influenza vaccines during the 2019/20 season. Presented at IDWeek 2021, research revealed that the cell-based quadrivalent vaccine (QIVc) outperformed the egg-based version in preventing hospitalizations among the general population and high-risk groups. Additionally, the adjuvanted standard dose trivalent vaccine (aTIV) was as effective as the non-adjuvanted high-dose variant. These studies emphasize the public health significance of innovative vaccine technologies.

CSL's Global Chief Human Resources Officer, Elizabeth Walker, has joined the Board of Directors for the Urban League of Philadelphia. Walker emphasizes CSL's commitment to equitable community support while addressing public health concerns. The partnership aims to enhance public health, leadership development, and workforce diversity. With CSL's U.S. headquarters in Philadelphia and operations in over 100 countries, this collaboration will strengthen community outreach and plasma donation awareness.

CSL Plasma announced a flu vaccination voucher program for U.S. plasma donors starting Sept. 1, 2021. Donors completing two plasma donations within a month will receive a voucher for a free flu vaccine at Walgreens pharmacies. Vouchers will be sent via the CSL Plasma donor app or through text and email. The program aims to enhance donor health, aligning with CSL Plasma's commitment to community health. The last eligibility for vouchers is December 2021, with expiration on Dec. 31, 2021. CSL Plasma is a subsidiary of CSL Behring, a global leader in biotherapeutics.

Seqirus, a leader in influenza prevention and part of CSL Limited (ASX:CSL), announced the launch of a dedicated self-amplifying messenger RNA (sa-mRNA) vaccine program. This initiative aims to advance the development of influenza vaccines, with clinical trials for seasonal and pandemic vaccine candidates expected to begin in the latter half of 2022. The company has appointed Roberta Duncan as Vice President, mRNA Program Lead, to oversee this initiative. Sa-mRNA technology is projected to improve vaccine effectiveness and reduce dosage requirements, enhancing public health responses to influenza.

CSL Behring announced an update from the EAN and PNS Task Force on CIDP treatment guidelines, recommending subcutaneous immunoglobulin (SCIg) for maintenance therapy. This marks the first inclusion of SCIg in the guidelines since 2010, reflecting its evidence-based efficacy. The guideline specifies that SCIg dosage should be individualized and advises against its use for induction treatment. Hizentra, CSL Behring's SCIg product, remains the most prescribed treatment for CIDP. This update is expected to empower physicians in managing CIDP, enhancing patient convenience and potentially reducing treatment side effects.