The Investor
27 Mar 2026, 21:00
GSK plc announced that the European Medicines Agency has accepted for review its investigational therapy Bepirovirsen for the treatment of chronic hepatitis B.
The submission is supported by Phase III B-Well trials, which showed statistically significant and clinically meaningful functional cure rates compared with standard of care alone. The therapy also demonstrated an acceptable safety and tolerability profile.
Bepirovirsen is a potential first-in-class treatment designed to target and suppress hepatitis B virus activity while enabling the immune system to regain control of the infection.
Chronic hepatitis B affects millions of people in Europe and remains a leading cause of liver cancer, with current treatments often requiring lifelong therapy. A regulatory decision on the application is expected following the EMA review process.
The submission is supported by Phase III B-Well trials, which showed statistically significant and clinically meaningful functional cure rates compared with standard of care alone. The therapy also demonstrated an acceptable safety and tolerability profile.
Bepirovirsen is a potential first-in-class treatment designed to target and suppress hepatitis B virus activity while enabling the immune system to regain control of the infection.
Chronic hepatitis B affects millions of people in Europe and remains a leading cause of liver cancer, with current treatments often requiring lifelong therapy. A regulatory decision on the application is expected following the EMA review process.
