Ionis wins FDA approval for TRYNGOLZA, its first independently commercialized drug

Filed June 24, 2026 · Period ending June 24, 2026 · ~1 min read

Key Changes

• high

  FDA approved TRYNGOLZA (olezarsen) to reduce triglycerides and acute pancreatitis risk in adults with severe hypertriglyceridemia (≥500 mg/dL); first approved therapy indicated for pancreatitis risk reduction in this population.

  Item 8.01 — Other Events verify on EDGAR →
• high

  Phase 3 trials showed triglyceride reductions up to 72% at six months (sustained at 12 months) and acute pancreatitis event reductions up to 91%; 86% of patients reached the critical <500 mg/dL threshold.

  Item 8.01 — Other Events verify on EDGAR →
• high

  Addressable U.S. market exceeds 3 million patients with severe hypertriglyceridemia, including 1 million high-risk patients; U.S. launch scheduled for July 2026.

  Exhibit 99.1 verify on EDGAR →