07:55 AM EST, 12/01/2025 (MT Newswires) -- Ionis Pharmaceuticals ( IONS ) said Monday the US Food and Drug Administration has granted breakthrough therapy designation to olezarsen as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia.

The company said the designation was supported by results from phase 3 studies in which olezarsen cut triglycerides by up to 72% and reduced acute pancreatitis events by 85%.

Ionis Pharmaceuticals ( IONS ) said nearly 90% of treated patients achieved triglyceride levels below the 500 mg/dL level, which is below the risk threshold for acute pancreatitis.

The company said it plans to submit a supplemental new drug application to the US FDA by end of the year.