TRYNGOLZA (olezarsen) - (CORE)

June 24, 2026: Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced the FDA approval of TRYNGOLZA (olezarsen) as an adjunct to diet to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (TG ≥500 mg/dL). TRYNGOLZA is offered in 50 mg and 80 mg doses and is self-administered once monthly via autoinjector; U.S. availability is expected in July.

Approval was based on Phase 3 CORE (NCT05079919; n=617) and CORE2 (NCT05552326; n=446) randomized, double-blind, placebo-controlled trials. The studies met the primary endpoint, showing statistically significant reductions in fasting triglycerides at six months versus placebo (50 mg: 49%–63%; 80 mg: 55%–72%) and sustained effects to 12 months. TRYNGOLZA also significantly reduced acute pancreatitis events at 12 months (91% reduction with 50 mg; 76% with 80 mg; pooled 85%). Among patients with baseline and 12-month data, 86% achieved TG <500 mg/dL. Most common sHTG adverse reactions were injection site reactions and liver enzyme increases.

Ionis will host a webcast on June 24, 2026 at 3:30 p.m. ET.