Business Context and Reporting Period
Company: GSK plc
Filing Type: Form 6-K (Report of Foreign Private Issuer)
Date: February 26, 2026
Subject: Regulatory milestone for investigational drug linerixibat.
Key Financial Metrics
This filing is a current report regarding a regulatory development and does not contain financial statements. The filing text does not provide clear values for revenue, profit, cash flow, margins, debt, or liquidity.
Material Changes
The primary material change reported is the acceptance of a new drug application (NDA) by China's National Medical Products Administration (NMPA) for linerixibat. Key details include:
- Indication: Treatment of cholestatic pruritus in patients with primary biliary cholangitis (PBC).
- Review Status: Accepted for priority review in China.
- Global Status: Marketing applications are currently under review in the US, EU, UK, and Canada. The drug is not yet approved anywhere in the world.
- Orphan Designation: Granted in the US, EU, and Japan.
Guidance, Outlook, and Risks
Management Commentary: The application is based on positive data from the GLISTEN Phase III trial, which met primary and key secondary endpoints demonstrating significant and sustained improvement in cholestatic pruritus versus placebo. The safety profile was consistent with previous studies.
Market Context: Approximately 280,000 people in China are affected by PBC, with cholestatic pruritus impacting up to 89% of patients. Few effective treatment options currently exist.
Risks and Contingencies: The filing includes a cautionary statement regarding forward-looking statements. Actual results may differ materially due to risks described in GSK's Annual Report on Form 20-F for 2024 and Q4 Results for 2025, including regulatory approval uncertainties.
Investor Verification Checklist
- Confirm the timeline for the priority review decision by China's NMPA.
- Monitor the status of concurrent marketing applications in the US, EU, UK, and Canada.
- Review the full GLISTEN Phase III trial data published in the Lancet Gastroenterology & Hepatology (2026) for detailed efficacy and safety profiles.
- Assess the commercial potential of linerixibat given the estimated patient population in China and globally.
- Check for any updates on GSK's broader hepatology pipeline, including therapies for chronic hepatitis B and steatotic liver disease (SLD).