GSK Out-Licenses Rights for Rare Liver Disease Drug to Alfasigma

GSK plc GSK signed a license agreement with Italy-based Alfasigma. Per the terms of the agreement, Alfasigma has acquired exclusive global rights from GSK to develop and market linerixibat, an investigational therapy for treating cholestatic pruritus in patients with primary biliary cholangitis (PBC).

PBC is a chronic autoimmune disease in which bile flow from the liver is disrupted, leading to a build-up of bile acids. This excess bile can cause intense itching, called cholestatic pruritus, which cannot be relieved by scratching.

In return for granting these rights, GSK will receive $300 million as an upfront payment from Alfasigma. The company will be eligible to receive milestone payments, including $100 million upon the FDA’s approval of the drug, $20 million upon approvals in the EU and the UK, and up to $270 million in sales-based milestone payments. In addition, GSK will be eligible to receive tiered double-digit royalties on linerixibat’s net sales worldwide.

GSK Stock’s Performance

Year to date, shares of GSK have gained 13% compared with the industry’s 6% growth.

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More on GSK’s Linerixibat

Linerixibat is an orally-administered drug designed to inhibit the ileal bile acid transporter (IBAT), which reduces multiple mediators of pruritus in circulation. The drug is yet to be approved anywhere in the world.

Last year, GSK reported full results from the late-stage GLISTEN study, which evaluated linerixibat in PBC patients with cholestatic pruritus. The study achieved its primary and key secondary endpoints — treatment with the drug led to rapid, significant and sustained improvement in cholestatic pruritus and itch-related sleep interference compared with placebo.

Based on the above results, GSK submitted regulatory filings for linerixibat across the United States, the EU, the UK, China and Canada. A final decision from the FDA is expected by March 24, 2026.

GSK’s Zacks Rank

GSK currently carries a Zacks Rank #3 (Hold).

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