Ionis Pharmaceuticals, Inc. (IONS), Thursday announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental New Drug Application for olezarsen for the treatment of severe hypertriglyceridemia or sHTG.
With the Prescription Drug User Fee Act or PDUFA target action date set for June 30, 2026, the company believes that this milestone represents a significant step toward its goal of delivering the first-ever treatment shown to reduce the risk of potentially life-threatening acute pancreatitis attacks in patients with sHTG.
The sNDA and Priority Review designation were based on the positive results from the Phase 3 CORE and CORE2 studies, which showed that olezarsen demonstrated a highly statistically significant placebo-adjusted reduction in triglyceride levels of up to 72 percent and an 85 percent reduction in acute pancreatitis events with favorable safety and tolerability.
In the pre-market hours, IONS is trading at $81.56, up 0.78 percent on the Nasdaq.
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