Ionis Phase 3 Balance study of olezarsen meets primary endpoint; reduces acute pancreatitis in FCS

IONIS PHARMACEUTICALS INC

Olezarsen 80 mg reduced fasting triglycerides by 44% vs placebo at 6 months (p<0.001).
Acute pancreatitis events: 1 event in 80 mg group vs 11 in placebo over 12 months.
All-cause hospitalizations reduced by 84% (placebo-adjusted) from baseline to 12 months.
No serious treatment-emergent AEs related to olezarsen; serious AEs 14% (80 mg) vs 39% placebo.
Ionis to pursue regulatory approval for first potential FCS treatment in U.S.; data published in NEJM.

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