Core Insights - GSK shared data from two pivotal Phase 3 studies, B-Well 1 and B-Well 2, for bepirovirsen, an investigational treatment for chronic hepatitis B, involving over 1,800 patients [1] - The studies met their primary endpoint, showing a statistically significant and clinically meaningful functional cure rate for bepirovirsen compared to standard care alone [3] - If approved, bepirovirsen could become the first finite, six-month therapeutic option for chronic hepatitis B [5] Financial and Partnership Details - Ionis received an upfront payment, license fee, and development milestone payments from GSK, with potential additional payments of $150 million and tiered royalties of 10-12% on net sales of bepirovirsen [2] - The collaboration between Ionis and GSK began in 2019 when GSK licensed bepirovirsen from Ionis [1] Study Results and Future Plans - The B-Well studies demonstrated an acceptable safety and tolerability profile consistent with previous studies, with full results to be presented at a scientific congress and submitted for regulatory approvals in early 2026 [4] - The studies showed significantly higher functional cure rates in patients with baseline surface antigen levels ≤1000 IU/ml [3] Analyst Commentary - Analysts from William Blair noted that Ionis is well-positioned with five Phase 3 readouts expected in 2026, highlighting bepirovirsen as an underappreciated opportunity in the market [6] - The performance of Gilead Science's Vemlidy, projected to exceed $1 billion in revenue for fiscal 2025, suggests a growing market for hepatitis B treatments [6] Market Reaction - Following the announcement, Ionis Pharmaceuticals shares increased by 4.06% to $84.80, while GSK shares rose by 1.20% to $51.16 [8]
GSK/Ionis Partnered Investigational Drug Shows Strong Results In Large Hepatitis B Studies