IONIS-APOCIII-LRx (Olezarsen)
Ionis PharmaceuticalsIONS
- Indication
- Severe hypertriglyceridemia (sHTG)
- Stage
- PDUFA
- Event
- PDUFA Approval decision
- Details
June 4, 2026 — Ionis Pharmaceuticals (NASDAQ: IONS) announced it will present new analyses from its Phase 3 CORE and CORE2 pivotal studies of olezarsen (an APOC3 inhibitor) in severe hypertriglyceridemia (sHTG) across four oral presentations at the 2026 American Diabetes Association Scientific Sessions (June 5–8, New Orleans), National Lipid Association Scientific Sessions (June 11–14, Chicago), and ENDO 2026 (June 13–16, Chicago). The company said the analyses will examine outcomes in different clinical subgroups, including patients with diabetes, varying triglyceride levels and prior pancreatitis, and with vs. without baseline fibrate use. Ionis reiterated previously reported CORE/CORE2 results showing olezarsen produced a highly statistically significant reduction in fasting triglycerides and acute pancreatitis events, with favorable safety and tolerability. Business significance: Ionis noted olezarsen’s marketing application for sHTG is under FDA Priority Review with a target action date of June 30, 2026; positive subgroup analyses could support adoption if approved.
- Source
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Financial Snapshot
Market Cap
$12.2B
Price
$74.58