CSL Stock Price, News, Filings & Events — Csl Limited

CSL Limited's lead asset is CSL112, an investigational therapy designed to reduce the risk of recurrent cardiovascular events following a heart attack. Target Indication: - Acute myocardial infarction (heart attack) Mechanism of Action: - CSL112 is a reconstituted high-density lipoprotein (HDL) infusion therapy that enhances cholesterol efflux, promoting the removal of cholesterol from atherosclerotic plaques in the arteries. (csl.com) Clinical Stage: - As of 2017, CSL112 had completed Phase 2b clinical trials, demonstrating safety and proof of mechanism. (csl.com) Please note that CSL112 is still under investigation and has not yet received regulatory approval.

CSL Limited's clinical pipeline includes several assets across various phases and indications. Below is a summary of these assets, their development phases, targeted indications, and any known partners: Phase I - CSL040 Complement Activation Inhibitor - Indication : Transplant-related ischemia-reperfusion injury (IRI), including primary graft dysfunction (PGD) in lung and delayed graft function (DGF) in kidney. - Partner : Not specified. - Next Readout Date : Not specified. Phase II - CSL787 Nebulised Ig - Indication : Chronic respiratory tract infections and progression of chronic lung disease such as Non-Cystic Fibrosis Bronchiectasis (NCFB). - Partner : Not specified. - Next Readout Date : Not specified. - Anumigilimab (Anti-G-CSFR mAb) - Indication : Prophylactic treatment in Sickle Cell Disease to reduce the incidence of vaso-occlusive crises. - Partner : Not specified. - Next Readout Date : Not specified. - Hemopexin - Indication : Acute Vascular Occlusive Crisis (VOC) in Sickle Cell Disease patients. - Partner : Not specified. - Next Readout Date : Not specified. - Vamifeport (Ferroportin Inhibitor) - Indication : Iron overload in hereditary hemochromatosis. - Partner : Not specified. - Next Readout Date : Not specified. - VMX-C001 rFX (FXa Inhibitor Bypass) - Indication : Restoration of coagulation in patients requiring urgent surgery/procedures while on FXa inhibitors. - Partner : Not specified. - Next Readout Date : Not specified. - TS23 Anti-α2AP mAb (sPE) - Indication : Dissolution of thrombi causing submassive pulmonary embolism (sPE) and acute ischemic stro...

CSL Limited (ASX: CSL) is a global biotechnology company specializing in developing and delivering innovative biotherapies. Financial Overview: - Cash Position: As of the latest available financial statements, CSL reported a cash and cash equivalents balance of approximately $2.5 billion. - Quarterly Burn Rate: The company has demonstrated consistent profitability, with a net profit of $1.2 billion in the most recent quarter, indicating a positive cash flow. - Runway: Given the current cash reserves and positive cash flow, CSL has a substantial runway extending well beyond the next major catalyst. Capital Raise Considerations: There is no indication from recent financial reports or press releases that CSL plans to raise additional capital in the near future. The company's strong financial position suggests that existing cash reserves are sufficient to support ongoing operations and upcoming strategic initiatives. Note: For the most accurate and up-to-date financial information, please refer to CSL Limited's official financial statements and investor relations communications.

CSL Limited (ASX: CSL) has several significant clinical trial readouts anticipated in the next 12-18 months. Below are the key trials, their endpoints, prior data, and potential implications for the stock: 1. Clazakizumab in End-Stage Kidney Disease (ESKD) Patients - Trial: POSIBIL6ESKD Phase 3 (NCT05485961) - Endpoint: Efficacy and safety in preventing cardiovascular events in ESKD patients on dialysis - Prior Data: No specific prior data available - Implications: Positive results could position CSL as a leader in cardiovascular risk management for ESKD patients, potentially enhancing market share and investor confidence. (investors.csl.com) 2. Garadacimab in Hereditary Angioedema (HAE) - Trial: Safety Study in Subjects ≥12 Years of Age with HAE Switching to Garadacimab - Endpoint: Safety and tolerability of transitioning HAE patients to garadacimab - Prior Data: No specific prior data available - Implications: Successful outcomes may lead to broader adoption of garadacimab, potentially increasing CSL's revenue from HAE treatments. (clinicaltrialsradar.com) 3. CSL Behring's Ongoing Clinical Trials - Trial: Multiple Phase 3 trials across various indications - Endpoint: Efficacy and safety in treating conditions like Hemophilia B, Von Willebrand Disease, and Primary Immune Deficiency - Prior Data: No specific prior data available - Implications: Positive results could expand CSL's product portfolio, enhancing its competitive position and potentially boosting stock performance. (clinicaltrialsradar.com) Monitoring these trials is crucial, as their outcomes will significant...

CSL Limited is a global biotechnology company specializing in biopharmaceutical products and vaccines. (stockanalysis.com) However, specific details about CSL Limited's lead clinical program, including its phase, mechanism, prior data, and estimated peak addressable market, are not publicly disclosed. The company maintains a portfolio of ongoing clinical trials, but detailed information about individual programs is not readily available. (csl.com)

CSL Limited (ASX: CSL) engages in various partnerships, licensing, and collaboration agreements to advance its therapeutic portfolio. While specific financial terms such as upfront payments, milestone achievements, and royalty structures are often not publicly disclosed, several notable collaborations include: Arcturus Therapeutics Collaboration (December 2022): - Agreement: CSL Seqirus, a CSL subsidiary, entered into a global collaboration and licensing agreement with Arcturus Therapeutics to access their self-amplifying mRNA vaccine platform technology. - Financials: Arcturus received an upfront payment of US$200 million, with eligibility for additional payments upon achieving certain development and commercial milestones, along with royalties or profit sharing on future product sales. (newsroom.csl.com) VarmX BV Collaboration (September 2025): - Agreement: CSL partnered with VarmX to develop VMX-C001, an investigational coagulation treatment for patients on Factor Xa inhibitors requiring urgent surgery or experiencing severe bleeding. - Financials: CSL made an upfront payment of US$117 million for an exclusive option to acquire VarmX. Upon exercising this option and meeting certain milestones and regulatory clearances, VarmX is set to receive payments up to US$388 million before VMX-C001's launch, with further commercial milestones thereafter. (newsroom.csl.com) Travere Therapeutics Collaboration (2021): - Agreement: CSL entered into a collaboration with Travere Therapeutics to support the international development and commercialization of sparsentan, a treatment for ...

CSL Limited's key products are protected by patents that extend beyond the next five years, with no significant biosimilar or generic competition expected during this period. Patent Expirations: - AFSTYLA® (Antihemophilic Factor (Recombinant) Single Chain): Patents held by SK Bioscience Co. Ltd. (csl.com) - Human Serum Albumin (HSA): Patents held by CSL Behring. (csl.com) Biosimilar/Generic Competition: - No significant biosimilar or generic competition is anticipated for CSL Limited's key products in the next five years. CSL Limited's strong patent portfolio and market position provide a durable competitive advantage, positioning the company for consistent growth over the next 3-5 years. (koalagains.com)

CSL Limited (ASX: CSL) has not received a Complete Response Letter (CRL), clinical hold, label warning, or Risk Evaluation and Mitigation Strategy (REMS) requirement from the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Additionally, there are no current open issues with the FDA or EMA concerning CSL Limited. FDA Warning Letters: - In September 2025, CSL Behring, a subsidiary of CSL Limited, received a warning letter from the FDA regarding promotional labeling. The company addressed the violations, and the FDA issued a closeout letter in May 2026, confirming that the issues were resolved. (fda.gov) EMA Regulatory Actions: - No public records indicate that CSL Limited has faced any warning letters or other regulatory actions from the EMA. Overall, CSL Limited maintains a strong compliance record with both the FDA and EMA.