GSK's Chronic Hepatitis B Drug Meets Goals in Two Late-Stage Studies

Core Insights - GSK plc announced positive results from two phase III studies for its investigational chronic hepatitis B therapy, bepirovirsen [1][8] - Both studies met their primary endpoints, showing a statistically significant functional cure rate when bepirovirsen was combined with the current standard of care [2][8] - GSK plans to submit regulatory filings for bepirovirsen globally in the first quarter of 2026, aiming to position it as a finite six-month therapeutic option for chronic hepatitis B [5][8] Study Results - Treatment with bepirovirsen plus standard care demonstrated a meaningful functional cure rate in patients with baseline HBsAg of 3000 IU/ml or lower [2][3] - Functional cure is defined as the sustained loss of HBsAg and undetectable hepatitis B virus DNA for at least 24 weeks post-treatment [3] - GSK reported that bepirovirsen was particularly effective in patients with baseline HBsAg of 1000 IU/ml or lower, although specific numerical data was not disclosed [3][4] Market Potential - GSK estimates that chronic hepatitis B affects over 250 million people globally, indicating a significant market opportunity for bepirovirsen [5] - If approved, bepirovirsen could be the first therapy to achieve a meaningful functional cure for chronic hepatitis B [5] Stock Performance - Year to date, GSK shares have increased by 50%, outperforming the industry growth of 21% [7]