Business
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
CARLSBAD, Calif., April 28, 2026--Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) partner GSK today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of adults with chronic hepatitis B (CHB). The FDA has granted bepirovirsen Breakthrough Therapy designation and set a Prescription Drug User Fee Act (PDUFA) target action date of October 26, 2026.
About this update from Ionis Pharmaceuticals, Inc.
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":1024,"height":512,"url":"https://media.zenfs.com/en/business-wire.com/237788802bc2d9cd3f6f2978ab855272"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/yISJcxbOuQTL.0QzadAO1g--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTQ4MA--/https://media.zenfs.com/en/business-wire.com/237788802bc2d9cd3f6f2978ab855272","width":960,"height":480},"lightbox":{"url":"https://s.yimg.com/ny/api/res/1.2/7MgJ.kxfPKkmxFpeXiGetw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTIwNDg7aD0xMDI0/https://media.zenfs.com/en/business-wire.com/237788802bc2d9cd3f6f2978ab855272","width":1024,"height":512}},"lazy":false},{"type":"text","content":"– Regulatory submission supported by Phase 3 B-Well trials demonstrating statistically significant and clinically meaningful functional cure rates in chronic hepatitis B -","length":171,"tagName":"p","attribs":{}},{"type":"text","content":"– Breakthrough Therapy designation added to Fast Track Designation, recognizing potential for substantial improvement over existing treatments –","length":144,"tagName":"p","attribs":{}},{"type":"text","content":"– Chronic hepatitis B is a leading cause of liver cancer globally –","length":67,"tagName":"p","attribs":{}},{"type":"text","content":"– PDUFA Date of October 26, 2026 –","length":34,"tagName":"p","attribs":{}},{"type":"text","content":"CARLSBAD, Calif., April 28, 2026--(BUSINESS WIRE)--Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) partner GSK today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of adults with chronic hepatitis B (CHB). The FDA has granted bepirovirsen Breakthrough Therapy designation and set a Prescription Drug User Fee Act (PDUFA) target action date of October 26, 2026.","length":513,"tagName":"p"},{"type":"text","content":""Over one million people in the U.S. are living with chronic hepatitis B and as of today, require lifelong antiviral therapy to suppress the virus," said Brett P. Monia, Ph.D., chief executive officer, Ionis. "As the first medicine to deliver clinically meaningful functional cure rates, bepirovirsen is uniquely positioned to effectively treat CHB based on its potential ...