– Regulatory submission supported by Phase 3 B-Well trials demonstrating statistically significant and clinically meaningful functional cure rates in chronic hepatitis B - – Breakthrough Therapy designation added to Fast Track Designation, recognizing potential for substantial improvement over
Ionis partner GSK announces bepirovirsen accepted for Priority Review and granted Breakthrough Therapy Designation by U.S. FDA as a potential first-in-class medicine for chronic hepatitis B
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April 28, 2026
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Ionis Pharmaceuticals, Inc. News Releases
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