GSK’s Linerixibat NDA Moves Forward with FDA Acceptance

PUBLISHED: 02 Jun 2025 @ 18:20 | Comments (0) | More info about Fiona Craig

GlaxoSmithKline (LSE:GSK) has announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for linerixibat, a targeted inhibitor designed to treat cholestatic pruritus in patients with primary biliary cholangitis (PBC). The submission follows encouraging results from the GLISTEN phase III clinical trial, which showed significant symptom improvement over placebo.

If approved, linerixibat could fulfill a substantial unmet medical need for patients affected by this challenging condition, potentially strengthening GSK’s footprint in the hepatology sector.

GSK’s outlook remains strong, supported by positive technical indicators and favorable investor sentiment stemming from recent earnings. Strategic initiatives such as share repurchases and product approvals contribute to this positive momentum. However, the company’s elevated debt levels introduce some risk, slightly moderating the overall outlook.

More about GlaxoSmithKline

GSK is a leading global biopharmaceutical company dedicated to leveraging science, technology, and talent to combat diseases. The company focuses on developing treatments for a range of liver conditions, including primary biliary cholangitis (PBC), chronic hepatitis B, alcohol-related liver disease, and metabolic dysfunction-associated steatohepatitis.

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