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StocksMedium•28 April 2026•

1 min read

GSK and Ionis Drug Bepirovirsen Granted FDA Priority Review for Chronic Hepatitis B

Key Facts

1The U.S. FDA accepted the New Drug Application for bepirovirsen for Priority Review to treat chronic hepatitis B.

2The FDA granted bepirovirsen Breakthrough Therapy designation and set a PDUFA target action date of October 26, 2026.

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application for bepirovirsen, developed by GSK in partnership with Ionis Pharmaceuticals, for Priority Review. This innovative treatment is designed for adults with chronic hepatitis B and has also received the FDA's Breakthrough Therapy designation. Following this acceptance, the FDA has set a PDUFA target action date of October 26, 2026, for its final decision. The designation is based on bepirovirsen's potential as a first-in-class antisense oligonucleotide therapy. This regulatory milestone is viewed as a positive development for both GSK and Ionis within the biotechnology sector. While the final decision date is distant, the priority status underscores the drug's potential to address significant unmet medical needs.