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 ...
Ionis Pharmaceuticals, Inc. (IONS)
Last ionis pharmaceuticals, inc. earnings: 2/26 07:00 am
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Source: Business Wire
– 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 existing treatments –– Chronic hepatitis B is a leading cause of liver cancer globally –– PDUFA Date of October 26, 2026 – CARLSBAD, Calif.--(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.“Over one million people in the U.S. are living with chronic hepatitis B and as of
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- A Look At Ionis Pharmaceuticals (IONS) Valuation After Strong One Year Returns And Recent Pullback [Yahoo! Finance]Yahoo! Finance
- Ionis Pharmaceuticals (IONS) had its price target lowered by TD Cowen from $110.00 to $108.00. They now have a "buy" rating on the stock.MarketBeat
- Ionis Pharmaceuticals (IONS) was upgraded by Canaccord Genuity Group Inc. to "strong-buy".MarketBeat
- Ionis (IONS) Q4 2025 Earnings Transcript [Globe and Mail, The (Toronto, Canada)]Globe and Mail, The
- Ionis Pharmaceuticals (IONS) had its "overweight" rating reaffirmed by Morgan Stanley.MarketBeat
IONS
Earnings
- 2/25/26 - Miss
IONS
Sec Filings
- 4/28/26 - Form 144
- 4/23/26 - Form DEF
- 4/23/26 - Form ARS
- IONS's page on the SEC website