GSK’s investigational antisense oligonucleotide, bepirovirsen, successfully met its primary efficacy endpoints in the B-Well 1 and B-Well 2 Phase III studies involving a combined 1,825 patients with chronic hepatitis B. Both trials demonstrated statistically significant functional cure rates—defined as sustained loss of hepatitis B surface antigen—of 23% and 21% respectively at 48 weeks, compared with less than 1% in placebo arms. Safety profiles were consistent across treatment and control groups, with mild injection-site reactions reported in under 5% of patients. These results position bepirovirsen as a potential first finite, six-month therapy for chronic hepatitis B, breaking decades of reliance on lifelong antiviral suppression.

Building on the robust Phase III data, GSK has confirmed plans to submit marketing applications for bepirovirsen to both the U.S. Food and Drug Administration and the European Medicines Agency in Q1 2026. The company has already initiated rolling submissions for chemistry, manufacturing and controls documentation, anticipating priority review pathways in both jurisdictions. GSK’s regulatory teams expect review timelines of approximately 10 months in the U.S. and 210 days in the EU, targeting potential approvals by late 2026 and rollout in key markets shortly thereafter.

In a multi-year anchor partnership with Noetik, GSK has licensed three of Noetik’s proprietary AI foundation models to enhance its cancer therapeutic research and development platform. The collaboration grants GSK access to pre-trained natural language processing and generative chemistry engines, integrating into GSK’s internal discovery workflows used by more than 50 computational biologists and medicinal chemists. Financial terms include an upfront payment of $75 million and up to $125 million in milestone-linked fees over five years, with potential for extended collaboration into late-stage clinical development.