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CSL Limited (ASX:CSL)

ALERT: Price-sensitive ASX Announcement for CSL
Current share price for CSL : $196.300 20.95 (11.95%)+
Announcement
Release
5 Oct 2026 8:22AM
Price at Release
$175.350
Full Release
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Summary
CSL Limited announced on 5 October 2026 that it had entered an exclusive agreement with Alentis Therapeutics to co-develop and co-promote lixudebart, an investigational monoclonal antibody and potential first-in-class treatment for rare kidney and liver diseases. The drug is being studied in a Phase 2 trial for ANCA-associated vasculitis with rapidly progressive glomerulonephritis (AAV-RPGN), a severe autoimmune disease that can rapidly cause irreversible kidney damage, and CSL said the collaboration also aims to advance lixudebart for focal segmental glomerulosclerosis (FSGS) and primary sclerosing cholangitis (PSC). CSL will pay Alentis an initial US$355 million, with up to US$1.2 billion in additional commercial milestone payments, and will fully fund completion of the ongoing Phase 2 RENAL trial, a planned Phase 3 trial in AAV-RPGN, Phase 2 trials in FSGS and PSC, and related development work; once commercialised, global profits will be shared 55 per cent to CSL and 45 per cent to Alentis. The announcement highlighted interim Phase 2 RENAL data showing promising kidney function improvements and Phase 1b FEGATO data indicating improved liver function, alongside favourable safety, tolerability and dose-dependent claudin-1 target engagement, supporting CSL’s strategy to build a leading global nephrology franchise through high-value external partnerships.
Key Points
  • CSL entered an exclusive agreement with Alentis Therapeutics to co-develop and co-promote lixudebart.
  • Lixudebart is a potential first-in-class treatment for rare kidney and liver diseases.
  • The lead indication is AAV-RPGN, a rare, severe autoimmune disease that can rapidly cause irreversible kidney damage and end-stage renal disease.
  • CSL and Alentis also plan to develop lixudebart for FSGS and PSC.
  • CSL will make an initial payment of US$355 million to Alentis.
  • Alentis may receive up to US$1.2 billion in additional commercial milestone payments.
  • CSL will fully fund the ongoing Phase 2 RENAL trial, the planned Phase 3 trial in AAV-RPGN, Phase 2 trials in FSGS and PSC, and supporting development activities.
  • Global profits will be shared 55 per cent to CSL and 45 per cent to Alentis once the product is commercialised.
  • Lixudebart targets exposed claudin-1, which is linked to inflammatory and fibrotic signalling pathways.
  • Interim Phase 2 RENAL data showed promising improvements in kidney function, and Phase 1b FEGATO data showed improved liver function with a favourable safety and tolerability profile.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.