$IONS (IONIS PHARMACEUTICALS) — 8-K: FDA approves GSK's Hibsago (bepirovirsen), licensed from Ionis, for chronic hepatitis B

The FDA approved Hibsago (bepirovirsen), a first-in-class RNA-targeted medicine licensed by GSK from Ionis, for chronic hepatitis B in combination with NrtI therapy in adults without cirrhosis. Approval was based on Phase 3 B-Well data showing functional cure rates of 19% versus less than 1% for standard of care after one year. The approval was granted under priority review and Breakthrough Therapy Designation. GSK continues regulatory submissions across multiple geographies with key decisions anticipated in the coming months.

The FDA approved Hibsago (bepirovirsen), a first-in-class RNA-targeted medicine licensed by GSK from Ionis, for chronic hepatitis B in combination with NrtI therapy in adults without cirrhosis. Approv