Ionis receives U.S. FDA Breakthrough Therapy designation for olezarsen for severe hypertriglyceridemia (sHTG)
Ionis Pharmaceuticals, Inc. (IONS)
Last ionis pharmaceuticals, inc. earnings: 2/26 07:00 am
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Source: Business Wire
– On track to submit supplemental new drug application by end of year – CARLSBAD, Calif.--(BUSINESS WIRE)--Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olezarsen as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (sHTG) (TG greater than or equal to 500 mg/dL). Breakthrough Therapy designation is intended to expedite the review of medicines that treat a serious or life-threatening condition and have shown preliminary clinical evidence indicating the potential for substantial improvement over available therapies.“The Breakthrough Therapy designation reflects the groundbreaking nature of the pivotal CORE and CORE2 study results, in which olezarsen significantly lowered triglycerides below the risk threshold of acute pancreatitis in the vast majority of patients,” said Sam Tsimikas, M.D., senior vice president, global cardiovasc
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IONS
Earnings
- 10/29/25 - Beat
IONS
Sec Filings
- 12/3/25 - Form 4
- 12/1/25 - Form 144/A
- 12/1/25 - Form 144
- IONS's page on the SEC website