The Investor
28 Apr 2026, 17:18
GSK plc announced that its investigational drug bepirovirsen has been accepted for priority review by the U.S. Food and Drug Administration for the treatment of chronic hepatitis B.
The therapy has also received Breakthrough Therapy Designation, highlighting its potential to significantly improve outcomes compared to existing treatments. The application is supported by Phase III trial data showing meaningful functional cure rates in patients.
The FDA has set a target decision date of October 26, 2026. If approved, bepirovirsen could address a major unmet need, as current therapies often require lifelong treatment and have low cure rates.
Source: GSK
The therapy has also received Breakthrough Therapy Designation, highlighting its potential to significantly improve outcomes compared to existing treatments. The application is supported by Phase III trial data showing meaningful functional cure rates in patients.
The FDA has set a target decision date of October 26, 2026. If approved, bepirovirsen could address a major unmet need, as current therapies often require lifelong treatment and have low cure rates.
Source: GSK
