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Biotechnology: Pharmaceutical Preparations
USFDAJun 24, 2026, 03:53 PM

Ionis' TRYNGOLZA Approved by FDA for Severe Hypertriglyceridemia

AI Summary

Ionis Pharmaceuticals announced that the U.S. FDA has approved TRYNGOLZA (olezarsen) as an adjunct to diet to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG). The approval was based on positive Phase 3 CORE and CORE2 studies, which demonstrated up to 72% reduction in fasting triglyceride levels and up to 91% reduction in acute pancreatitis events. TRYNGOLZA, which is Ionis' first independent commercial launch in a prevalent condition, will be available in the U.S. in July.

Key Highlights

  • FDA approved TRYNGOLZA (olezarsen) for severe hypertriglyceridemia (sHTG).
  • Reduced fasting triglyceride levels by up to 72% in Phase 3 CORE and CORE2 studies.
  • Significantly reduced acute pancreatitis events by up to 91%.
  • 86% of patients achieved triglyceride levels below 500 mg/dL.
  • Number Needed to Treat (NNT) was 20 overall, and 4 for high-risk patients.
  • TRYNGOLZA will be available in the U.S. in July.