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Biotech Stocks Facing FDA Decision In March 2026

GSK plc
GSK plc

The FDA decision on GSK’s Linerixibat, an investigational oral targeted inhibitor of the ileal bile acid transporter, for the treatment of cholestatic pruritus in patients with Primary Biliary Cholangitis, is anticipated on March 24, 2026.

In Primary Biliary Cholangitis (PBC), a cholestatic liver disease, bile flow from the liver is disrupted. The resulting excess bile acids in circulation are thought to play a causal role in cholestatic pruritus, an internal itch that cannot be relieved by scratching.

Pruritus can occur at any stage of PBC disease or biochemical control and is experienced in varying degrees of severity by up to 90% of people living with PBC.

Linerixibat, if approved, will have to compete primarily with other approved ileal bile acid transporter (IBAT) inhibitors such as Mirum Pharma’s Maralixibat and Ipsen’s Odevixibat.

GSK closed Tuesday’s (Feb.24, 2026) trading at $59.12, down 0.24%.