Ionis 的 TRYNGOLZA（olezarsen）获欧盟 CHMP 积极意见，推荐批准用于重症高甘油三酯血症（sHTG），但欧盟商业化权益属 Sobi、Ionis 仅取授权提成

Ionis Pharmaceuticals (IONS) announced that the CHMP of the European Medicines Agency has adopted a positive opinion recommending an indication extension for TRYNGOLZA for the treatment of adults with severe hypertriglyceridemia (sHTG). The therapy would be used as an adjunct to diet and other lipid-lowering treatments.
Severe hypertriglyceridemia is characterized by very high levels of triglycerides, a type of fat found in the blood. Patients with the condition are at increased risk of acute pancreatitis, a potentially serious and painful inflammation of the pancreas.
If the recommendation is confirmed by the European Commission, TRYNGOLZA (olezarsen) would become the first and only RNA-targeted therapy authorized in the European Union for adults with sHTG and triglyceride levels of at least 880 mg/dL (=10 mmol/L). A final regulatory decision is expected in the fourth quarter of 2026.
The positive opinion was based on results from the pivotal Phase 3 CORE and CORE2 studies. The trials met their primary endpoints, with TRYNGOLZA demonstrating placebo-adjusted reductions in fasting triglyceride levels of up to 72% at six months, with the effect sustained through 12 months.
In a pooled analysis of the two studies, the treatment also demonstrated an 85% reduction in adjudicated acute pancreatitis events over 12 months compared with placebo. According to the company, TRYNGOLZA showed a favorable safety and tolerability profile, and the data were published in the New England Journal of Medicine.
Ionis noted that approximately two million people in the European Union are living with severe hypertriglyceridemia, including about 700,000 with triglyceride levels at or above 880 mg/dL.
TRYNGOLZA was approved in the United States for severe hypertriglyceridemia in June 2026. Outside the U.S., the therapy is being commercialized by Sobi under a licensing agreement with Ionis.
IONS has traded between $42.08 and $86.74 over the past year. The stock closed Thursday's trading at $44.12, up 3.33%. In pre-market trading the stock is at $44.39, up 0.61%.
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