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FDA Accepts Priority Review And Grants BT Designation For Bepirovirsen In Chronic Hepatitis B

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The FDA accepted GSK's New Drug Application for bepirovirsen for priority review in adults with chronic hepatitis B. Priority review signals an accelerated regulatory timeline and is a positive development for Ionis Pharmaceuticals' partner program. The news is constructive for the companies involved, though it is still an approval step rather than a final decision.

Analysis

The FDA accepted GSK's New Drug Application for bepirovirsen for priority review in adults with chronic hepatitis B. Priority review signals an accelerated regulatory timeline and is a positive development for Ionis Pharmaceuticals' partner program. The news is constructive for the companies involved, though it is still an approval step rather than a final decision.

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