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Finance

CSL strikes rare disease drug deal worth up to $1.6 billion with Swiss firm Alentis

Published by Global Banking & Finance Review

Posted on October 4, 2026

2 min read

· Last updated: October 4, 2026

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CSL, Alentis Announce $1.6B Rare Disease Drug Partnership Covering Kidney & Liver Diseases

CSL and Alentis Therapeutics Forge Major Collaboration in Rare Disease Treatments

Partnership Overview and Financial Terms

Oct 5 (Reuters) - Australia's CSL said on Monday it had entered into an agreement with Switzerland-based Alentis Therapeutics to co-develop and co-promote a treatment for rare kidney and liver diseases, in a deal worth up to $1.6 billion before development funding.

Under the partnership, CSL will make an upfront payment of $355 million, while Alentis is eligible for up to $1.2 billion in commercial milestone payments.

Details of the Agreement

The deal gives the Australian biotech giant rights to jointly develop and commercialise lixudebart, a potential first-in-class treatment being studied for rare kidney and liver diseases.

Lixudebart: A Promising Drug Candidate

Current Clinical Trials and Indications

Lixudebart, formerly known as ALE.F02, is currently in a Phase 2 trial for a rare autoimmune kidney disease that can cause irreversible kidney damage and end-stage renal disease.

Orphan Drug Designation

The drug was granted orphan drug designation — a special status granted by the US FDA to investigational therapies intended to prevent, diagnose, or treat rare diseases or conditions — for the treatment of idiopathic pulmonary fibrosis, or chronic lung disease, in 2024.

Future Development Plans

The companies also plan to advance the drug as a potential treatment for focal segmental glomerulosclerosis (FSGS), a chronic kidney disease, and primary sclerosing cholangitis (PSC), a chronic liver disease for which there is currently no approved therapy.

Commercialization and Profit Sharing

Once commercialised, global profits from the drug will be shared 55% to CSL and 45% to Alentis.

Reporting Credits

(Reporting by Rajasik Mukherjee in Bengaluru; Editing by Nia Williams)

Key Takeaways

  • The collaboration targets rare diseases including ANCA-associated vasculitis with rapidly progressive glomerulonephritis (AAV‑RPGN), focal segmental glomerulosclerosis (FSGS), and primary sclerosing cholangitis (PSC), with no approved therapies currently available for PSC.
  • Lixudebart (formerly ALE.F02), a monoclonal antibody targeting exposed Claudin‑1, has shown encouraging Phase 2 interim kidney data and Phase 1b liver data, with orphan drug status in idiopathic pulmonary fibrosis.
  • CSL will fund key trials (Phase 2 RENAL in AAV‑RPGN, Phase 3, plus Phase 2 FSGS and PSC), and on approval, global profits will be shared 55% to CSL and 45% to Alentis.

Frequently Asked Questions

What is the value of CSL's deal with Alentis Therapeutics?
The deal is worth up to $1.6 billion, including a $355 million upfront payment and up to $1.2 billion in milestone payments.
What diseases will the CSL-Alentis partnership target?
The partnership aims to develop treatments for rare kidney and liver diseases, including focal segmental glomerulosclerosis (FSGS) and primary sclerosing cholangitis (PSC).
What is lixudebart and what is its current development status?
Lixudebart, formerly ALE.F02, is a potential first-in-class drug in Phase 2 trials for rare autoimmune kidney disease.
How will profits from the commercialized drug be divided?
Global profits will be shared 55% to CSL and 45% to Alentis.
Has lixudebart received any special US FDA status?
Yes, lixudebart received orphan drug designation for idiopathic pulmonary fibrosis in 2024.

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