Biopharmaceutical company GSK plc (LSE: GSK) (NYSE: GSK) announced on Monday that it has agreed to grant pharmaceutical company Alfasigma S.p.A. worldwide exclusive rights to develop, manufacture and commercialise linerixibat, an investigational ileal bile acid transporter inhibitor being developed to treat cholestatic pruritus associated with primary biliary cholangitis.

Under the licence agreement, Alfasigma will take over global development and commercialisation of the therapy, which is currently under regulatory review in the US, European Union, UK, China and Canada following positive Phase III GLISTEN trial results demonstrating significant and sustained improvements in itching and sleep disruption compared with placebo.

GSK plc will receive an upfront payment of USD300m and a further USD100m upon approval from the United States Food and Drug Administration, expected ahead of transaction completion based on a 24 March 2026 PDUFA target date. The company is also eligible for USD20m linked to approvals in the European Union and UK, as well as up to USD270m in sales-related milestone payments and tiered double-digit royalties on global net sales.

Linerixibat has received Orphan Drug Designation in the US, European Union and Japan, and priority review status in China. The treatment is not yet approved for use in any market.

The agreement remains subject to customary closing conditions, including regulatory clearance under the United States Hart-Scott-Rodino Act.