IONIS PHARMACEUTICALS INC 8K

Ionis Pharmaceuticals received FDA approval for TRYNGOLZA (olezarsen) as the first and only therapy to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia, with U.S. commercial availability expected in July 2026.

Ionis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved TRYNGOLZA (olezarsen) as the first and only treatment indicated both to reduce triglycerides and to lower the risk of acute pancreatitis in adults with severe hypertriglyceridemia (TG ≥500 mg/dL), marking Ionis’ first independent commercial launch in a prevalent cardiometabolic condition. The approval is supported by positive Phase 3 CORE and CORE2 trial results showing rapid, durable triglyceride reductions of up to 72% versus placebo and up to a 91% reduction in acute pancreatitis events, with a favorable safety profile primarily characterized by injection site reactions and liver enzyme increases. TRYNGOLZA will be supplied as a 50 mg or 80 mg once-monthly, self-administered autoinjector, is already approved for familial chylomicronemia syndrome in multiple regions, and is expected to become commercially available in the U.S. for severe hypertriglyceridemia in July, with Ionis offering patient access support through its Ionis Every Step program and discussing the launch and approval on a webcast scheduled for June 24, 2026 at 3:30 p.m. ET.

Filing Facts

CIK

874015

Ticker

IONS

Form

8K

Source Type

sec

Accession

0001140361-26-026232

Alert Tier

7