GSK announced that its investigational antisense oligonucleotide bepirovirsen met the primary endpoint in two global Phase III trials, B-Well 1 (NCT05630807) and B-Well 2 (NCT05630820). Enrolling over 1,800 nucleos(t)ide analogue–treated patients across 29 countries, the studies assessed functional cure—defined as sustained loss of hepatitis B surface antigen (HBsAg) and undetectable HBV DNA for at least 24 weeks after treatment. Bepirovirsen added to standard of care delivered a statistically significant and clinically meaningful improvement in functional cure rates versus standard of care alone, with the greatest benefit observed in participants with baseline HBsAg ≤1,000 IU/ml. The safety and tolerability profile aligned with previous data, supporting regulatory submissions that could lead to the first finite, six-month therapeutic option for chronic hepatitis B.

Japan’s Ministry of Health, Labour and Welfare granted approval to GSK’s Exdensur (depemokimab) to treat severe or refractory bronchial asthma and chronic rhinosinusitis with nasal polyps. Approval was based on positive topline data from two Phase III studies, SWIFT and ANCHOR, which compared twice-yearly subcutaneous dosing of depemokimab plus standard of care against placebo. In SWIFT, Exdensur reduced annualized severe asthma exacerbation rates by 58% versus placebo, and in ANCHOR it achieved a 65% reduction in nasal polyp score at 24 weeks. The therapy’s biannual dosing regimen and robust efficacy endpoints position Exdensur as a differentiated option for patients uncontrolled on existing biologics.