Ionis reports Phase 3 olezarsen results: 72% TG reduction, 85% fewer pancreatitis events

IONIS PHARMACEUTICALS INC

• Primary endpoint met: up to 72% placebo-adjusted mean reduction in fasting triglycerides at 6 months, sustained through 12 months (p<0.001).
• 85% reduction in acute pancreatitis events (p<0.001); 86% of patients achieved TG <500 mg/dL, below risk threshold.
• Favorable safety profile; serious AEs lower in olezarsen (9-11%) vs placebo (14%); most common AE mild injection site reactions.
• sNDA for 50 mg and 80 mg doses to be submitted to FDA by end of 2025; PDUFA target action date in 2026.
• Data presented at AHA Scientific Sessions and simultaneously published in The New England Journal of Medicine.