<div id="readability-page-1"><div> (RTTNews) - Drugmaker GSK plc (GSK) on Tuesday announced positive Phase III trial results for investigational hepatitis B treatment bepirovirsen. Pooled data from the Phase III B-Well 1 and B-Well 2 trials showed that 19% of patients receiving bepirovirsen achieved a functional cure, compared with 0% in the placebo group. Among patients with lower baseline viral activity, defined as hepatitis B surface antigen levels of 1,000 IU/mL or less, the functional cure rate increased to 26%, also versus 0% for placebo. GSK said current standard therapies typically require lifelong treatment and achieve functional cure rates in less than 1% of patients. The company also reported that 23% of all bepirovirsen-treated patients achieved sustained viral suppression at week 72 after stopping therapy, compared with none in the placebo group. The trials enrolled more than 1,800 participants globally and demonstrated a safety profile consistent with previous studies. The most common side effects included injection site reactions and temporary increases in liver enzyme levels. Bepirovirsen is currently under priority review by the U.S. Food and Drug Administration and is also under regulatory review in Europe, Japan, and China. GSK said it expects the first regulatory decisions in the third quarter of 2026. The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. </div></div>

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GSK plc announced positive Phase III trial results for its hepatitis B treatment, bepirovirsen, with 19% of patients achieving a functional cure compared to 0% in the placebo group. In patients with lower viral activity, the cure rate rose to 26%. Additionally, 23% of treated patients maintained viral suppression at week 72 post-therapy. The trials involved over 1,800 participants and showed a safety profile similar to previous studies. Bepirovirsen is under priority review by the FDA, with regulatory decisions expected by Q3 2026.

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GSK Says Bepirovirsen Achieves Phase III Functional Cure Goal In Chronic Hepatitis B