Olezarsen sNDA accepted by the FDA for Priority Review for the treatment of severe hypertriglyceridemia (sHTG)
Ionis Pharmaceuticals, Inc. (IONS)
Last ionis pharmaceuticals, inc. earnings: 2/26 07:00 am
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Source: Business Wire
– PDUFA date set for June 30, 2026 – CARLSBAD, Calif.--(BUSINESS WIRE)--Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for olezarsen for severe hypertriglyceridemia (sHTG). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026.“Current standard of care therapies for sHTG provide limited benefit, leaving people vulnerable to recurrent and debilitating acute pancreatitis attacks with serious, long-term health consequences,” said Brett P. Monia, Ph.D., chief executive officer, Ionis. “The FDA’s Priority Review designation underscores the urgent need for additional treatment options and will enable us to bring olezarsen to patients as quickly as possible. This milestone represents a significant step toward our goal of delivering the first-ever treatment shown to reduce the risk of potentially life-threatening a
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- 2/25/26 - Miss
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- 2/26/26 - Form 10-K
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- 2/17/26 - Form SCHEDULE
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