Csl Ltd Stock Price, News & Analysis

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.

CSL Vifor (OTC:CSLLY) and Travere Therapeutics announced recognition of updated KDIGO clinical practice guidelines for IgA Nephropathy (IgAN) treatment. The 2025 guidelines highlight their drug FILSPARI® (sparsentan) as a potential first-line treatment approach, being the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA) with proven efficacy compared to optimized RASi in clinical trials.

The updated guidelines establish key treatment goals including proteinuria remission and slowing eGFR decline. FILSPARI, which is approved in the U.S. and Europe, has been launched in multiple European countries including Germany, Austria, Switzerland, Luxembourg, and the UK. The guidelines were presented at the International Symposium of IgA Nephropathy in September 2025.

CSL (CSLLY) has received FDA approval for ANDEMBRY (garadacimab-gxii), a groundbreaking treatment for hereditary angioedema (HAE) in patients aged 12 and older. ANDEMBRY is the first and only factor XIIa-targeting prophylactic treatment offering once-monthly dosing via a citrate-free autoinjector. The Phase 3 VANGUARD trial demonstrated exceptional efficacy, with 62% of patients remaining attack-free and a median reduction in HAE attacks of over 99% compared to placebo. The treatment showed a favorable safety profile, with nasopharyngitis and abdominal pain as the most common side effects. ANDEMBRY has already received approvals in multiple jurisdictions including Australia, UK, EU, Japan, Switzerland, and UAE, with immediate commercial launch planned in the US before the end of June 2025.

CSL Vifor announced that FILSPARI® (sparsentan) has received recommendation from England's National Institute for Health and Care Excellence (NICE) for treating IgA nephropathy. The treatment is approved for adults with urine protein excretion ≥1.0 g/day or urine protein-to-creatinine ratio ≥0.75 g/g. This marks the first non-immunosuppressive dual-action therapy recommended for this condition, which affects over 22,000 adults in England. The recommendation follows MHRA authorization in April 2025, with commercial availability expected from July 2025. IgA nephropathy, the most common primary glomerular disease worldwide, leads to kidney failure in 30-40% of patients within 10 years of diagnosis if not properly controlled. The NICE decision requires NHS England to fund the treatment within 90 days of final publication, expected on June 27, 2025.

CSL Vifor and Travere Therapeutics have achieved a significant milestone as the European Commission converts the conditional approval of FILSPARI to standard marketing authorization for treating IgA Nephropathy (IgAN).

FILSPARI, the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved in Europe for IgAN treatment, is currently available in Germany, Austria, and Switzerland. The approval covers all EU member states, Iceland, Liechtenstein, and Norway.

The decision follows positive phase-III PROTECT study results, which showed FILSPARI significantly slowed kidney function decline over two years compared to irbesartan. The drug is approved for adults with primary IgA nephropathy with specific urine protein excretion levels.

This standard approval, granted without changes to the indication, validates the clinical data and marks an important advancement for IgAN patients across Europe.

CSL Behring has received approval from Japan's MHLW for ANDEMBRY® (garadacimab), a first-in-class monoclonal antibody treatment for preventing hereditary angioedema (HAE) attacks. The treatment, administered via pre-filled pen for once-monthly subcutaneous injection, works by inhibiting activated Factor XII, the initiating factor in the HAE pathway.

The approval follows successful results from the international Phase 3 VANGUARD trial, with the detailed results published in The Lancet (April 2023) and Allergy (October 2024). ANDEMBRY has already received approvals in Australia, the United Kingdom, and the European Union.

HAE is a rare genetic disorder affecting approximately 430 diagnosed patients in Japan, with an estimated total patient population of 2,500 based on global prevalence rates of 1 in 50,000 people. The condition causes recurrent and unpredictable attacks of angioedema in multiple body sites.

CSL (CSLLY) and Arcturus Therapeutics announced that the European Commission has granted marketing authorization for KOSTAIVE®, the first self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older. The approval follows a positive CHMP opinion from December 12, 2024, and is valid across all EU member states and EEA countries.

KOSTAIVE, already marketed in Japan, demonstrated superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials. The approval is based on positive data from multiple studies, including an integrated phase 1/2/3 study and Phase 3 booster trials, which showed higher immunogenicity results versus a conventional mRNA COVID-19 vaccine comparator.

CSL and Arcturus Therapeutics (ARCT) have received European Commission marketing authorization for KOSTAIVE®, the first self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for individuals 18 and older. The approval follows a positive CHMP opinion from the European Medicines Agency on December 12, 2024.

KOSTAIVE demonstrated superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials. The approval is based on data from multiple studies, including an integrated phase 1/2/3 study showing efficacy and tolerability, and Phase 3 booster trials.

The vaccine is already marketed in Japan and will be valid across all EU member states and EEA countries. CSL is working to optimize KOSTAIVE's formulation to better serve healthcare professionals and patients in Europe.

CSL (CSLLY) has received European Commission approval for ANDEMBRY® (garadacimab), the first and only once-monthly treatment targeting factor XIIa for preventing hereditary angioedema (HAE) attacks in patients aged 12 and older. This marks the third regulatory approval for ANDEMBRY, following recent approvals in Australia and the UK.

The treatment comes with a patient-centric pre-filled pen for subcutaneous self-injection and works by inhibiting plasma protein factor XIIa. The approval is based on the Phase 3 VANGUARD trial and its open-label extension study, with results published in The Lancet (April 2023) and Allergy (October 2024).

HAE is a rare genetic disorder affecting approximately 1 in 50,000 people, characterized by recurrent and unpredictable attacks of angioedema. The treatment will be available following access and reimbursement negotiations, and is currently under review in the US, Japan, Switzerland, and Canada.