CSL Limited (ASX:CSL) shares gained 3.5% to around A$123.68 in early trading after the biotechnology group outlined plans for clinical trials to confirm the efficacy and safety of immunoglobulin produced using its next-generation Horizon 2 manufacturing process.
The patented technology is designed to significantly increase the amount of immunoglobulin produced from the same volume of plasma, potentially improving manufacturing efficiency and expanding supply.
Regulatory engagement shapes clinical program
Following discussions with the US Food and Drug Administration and the European Medicines Agency, CSL will generate additional clinical evidence to support and finalise the Horizon 2 regulatory approval process.
Clinical activities are expected to begin in mid-2027 using material manufactured at CSL’s Broadmeadows facility in Australia.
The trial work will run in parallel with construction of the previously announced expansion of the company’s manufacturing facility in Kankakee, Illinois.
CSL said further information on the duration of the clinical program and its effect on the regulatory approval timeline would be provided when available.
Focus on operational efficiency
Horizon 2 forms part of a broader program aimed at improving operational efficiency across CSL’s global manufacturing network.
The update comes as the company works to rebuild investor confidence following operational challenges and criticism of its acquisition strategy. Its shares remain substantially below their level a year ago.
CSL is also searching for a permanent chief executive, with former chief financial officer and 33-year company veteran Gordon Naylor currently serving as interim CEO.