CSL Limited ADR news reflects developments from a global biopharma company focused on plasma-derived therapies, vaccines and biotechnology medicines. Recurring updates cover CSL Behring, CSL Seqirus and CSL Vifor activities, including hemophilia and immune-deficiency therapies, influenza vaccines, iron-deficiency and nephrology treatments, and hereditary angioedema products.
Company news also includes clinical data and regulatory decisions for products such as HEMGENIX, ANDEMBRY and FILSPARI, manufacturing investments tied to plasma-therapy capacity and advanced production processes, and ADR program administration for the U.S. over-the-counter security.
CSL (CSLLY) has appointed Deborah Waterhouse as Chief Executive Officer and Managing Director, effective 1 February 2027. She has led ViiV Healthcare since 2017 and also serves as President of GSK Global Health. Gordon Naylor will remain interim CEO until the handover, then resume his role as a non-executive director. Waterhouse will retain her U.K. base and spend time in Australia, the U.S. and other operating markets.
Her contract provides £1,500,000 annual base salary, with short-term and long-term incentive awards tied to salary. She will receive restricted stock units valued at £7.71m to replace forfeited GSK awards, subject to adjustment and service conditions. A further £1.65m performance stock award carries performance and service conditions. She is restricted from involvement in CSL Seqirus until 31 March 2027 because of her previous employment in a competing business.
CSL (CSLLY) entered an exclusive global collaboration with Alentis Therapeutics to jointly develop and co-promote lixudebart for rare kidney and liver diseases. CSL will pay Alentis US$355 million initially, with Alentis eligible for up to an additional US$1.2 billion in commercial milestones. Once commercialised, global profits will be shared 55 per cent to CSL and 45 per cent to Alentis.
Lixudebart is being evaluated in the ongoing Phase 2 RENAL trial for ANCA-associated vasculitis with rapidly progressive glomerulonephritis, an autoimmune disease that can cause irreversible kidney damage. CSL will fully fund completion of that trial, a planned Phase 3 trial in the same disease, Phase 2 trials in focal segmental glomerulosclerosis, a progressive kidney disease, and primary sclerosing cholangitis, a chronic liver disease, plus supporting development activities.
CSL Seqirus (CSLLY) reported that pivotal Phase 3 results for its MF59-adjuvanted cell-based higher-dose quadrivalent influenza vaccine (aQIVc) in adults 50+ have been published in The Lancet Infectious Diseases.
The study of 7,699 participants across eight countries compared aQIVc with an adjuvanted egg-based quadrivalent and a recombinant quadrivalent influenza vaccine. aQIVc met primary objectives, showing superiority to the adjuvanted egg-based comparator across all four strains and age groups assessed, and non-inferiority to the recombinant vaccine for three of four strains in those 50+ and all four strains in those 65+. Immune responses persisted through the influenza season and the vaccine showed a well-tolerated safety profile, with most reactions mild or moderate and resolving within three days.
CSL (USOTC:CSLLY) reported positive top-line results from a multicenter, open-label Phase 3b study of ANDEMBRY (garadacimab-gxii) in children aged 2–11 years with hereditary angioedema (HAE). According to CSL, ANDEMBRY showed a favorable safety and tolerability profile consistent with earlier studies, and most participants remained attack-free over 12 months.
Children 6–11 years (n=16) received 100 mg once monthly, while those 2–5 years (n=6) received 100 mg every two months. ANDEMBRY is already approved in over 40 countries to prevent HAE attacks in patients 12 years and older. CSL plans to begin regulatory filings in the first half of its fiscal year to seek an expanded pediatric indication for ages 2–11, with full data to be presented at an upcoming scientific congress and submitted for publication.
CSL (OTC:CSLLY) and Vifor Fresenius Medical Care Renal Pharma announced that EMA’s CHMP has recommended revoking the EU marketing authorisation for TAVNEOS (avacopan), a treatment for severe, active GPA or MPA ANCA-associated vasculitis, following an Article 20 non-pharmacovigilance review of Phase 3 ADVOCATE trial data handling.
The opinion goes to the European Commission, whose final decision is pending. If confirmed, TAVNEOS will no longer be authorised in the EU, no new patients in the EU/EEA will start treatment, and current patients are advised to consult their physicians.
CSL (OTC:CSLLY) announced a $1.5 billion expansion of its Kankakee, Illinois plasma manufacturing facility, expected to be operational by 2031. The project adds Horizon 2 manufacturing to increase immunoglobulin yield, creates at least 300 pharmaceutical roles and ~800 construction jobs, and builds on >$3 billion invested in U.S. operations since 2018.
The expansion aims to boost production of plasma-derived therapies and albumin, strengthen domestic supply chains, and deepen CSL's U.S. manufacturing footprint.
Deutsche Bank (NYSE:DB) was appointed successor depositary bank for the sponsored American Depositary Receipt program of CSL Limited (OTC: CSLLY), effective January 27, 2026.
Key program details: Level I ADR, symbol CSLLY, CUSIP 12637N204, ISIN US12637N2045, custodial bank BNP Paribas in Sydney, and a conversion ratio of 2 ADSs:1 ordinary share. Depositary services will be provided by Deutsche Bank Trust Company Americas and affiliates.
uniQure (Nasdaq: QURE) five-year HOPE-B results published in NEJM on Dec 7, 2025 confirm long-term durability and safety of a single HEMGENIX infusion for adults with hemophilia B.
Key outcomes at year five: mean factor IX activity ~36.1%, adjusted annualized bleeding rate (ABR) for all bleeds reduced ~90% versus lead-in, joint bleeds reduced 93%, spontaneous bleeds reduced 94%, and 94% of patients remained off continuous prophylaxis. No serious adverse events were attributed to treatment; most treatment-related adverse events occurred in the first four months. Over 75 individuals across eight countries have received HEMGENIX in real-world use.
CSL (OTC:CSLLY) said its Broadmeadows, Australia plasma fractionation facility was named Overall Winner of the 2025 Facility of the Year Award by ISPE on Oct 26, 2025. The purpose-built plant uses Pharma 4.0 principles, advanced automation, real-time monitoring, robotics and a digital twin to enable flexible, paperless, multi-process manufacturing.
CSL reported the facility increased plasma processing capacity nine-fold to handle over 10 million litres annually, and cited modular design, reusable filters, energy-efficient systems and a fully automated robotic warehouse.
CSLLY (CSL Seqirus) announced real‑world evidence from the U.S. 2023/24 season showing cell‑based quadrivalent influenza vaccines had an estimated 19.8% relative vaccine effectiveness (rVE) versus standard egg‑based quadrivalent vaccines to prevent test‑confirmed influenza in ages six months to 64 years (106,779 vaccinated and tested patients; 95% CI 15.7–23.8%).
Sensitivity analyses and subgroup results (pediatric, adult, outpatient, high‑risk) were consistent. A modeled estimate suggests 14,930 additional hospitalizations could have been prevented if all vaccinated 6 months–64 years received cell‑based vaccines. Data were published and presented at IDWeek Oct 19–22, 2025.