05:30 AM EDT, 03/27/2026 (MT Newswires) -- GSK (GSK) said Friday that the European Medicines Agency has accepted for review its marketing authorisation application for the use of bepirovirsen, an investigational antisense oligonucleotide, in treating adults with chronic hepatitis B.

The regulatory submission is based on positive results from the B-Well 1 and B-Well 2 phase 3 trials, the company said. Both trials met their primary endpoint.

Functional cure rates were significantly higher with bepirovirsen plus standard of care compared with standard of care alone, according to GSK. Results were statistically significant across all ranked endpoints.

The current standard of care often requires lifelong therapy, and the functional cure rates remain low, typically only 1%, the company added.