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Form 8-K · Current Report · Filed 2025-11-10

Ionis Pharmaceuticals Announces Positive Phase 3 Results for Olezarsen in Severe Hypertriglyceridemia

On November 8, 2025, Ionis Pharmaceuticals, Inc.

Filer
Ionis Pharmaceuticals Inc. IONS · NASDAQ
Filed
Accession
0001140361-25-041225
CIK
0000874015
Signal
Medium impactHealthcare

Details

announced highly positive results from the pivotal Phase 3 CORE and CORE2 studies of olezarsen in patients with severe hypertriglyceridemia (sHTG). The studies demonstrated a statistically significant placebo-adjusted mean reduction in fasting triglyceride levels of up to 72% at six months, sustained through 12 months. Notably, olezarsen achieved an 85% reduction in acute pancreatitis events, a significant improvement for a condition that poses a high risk of life-threatening pancreatitis attacks. Additionally, 86% of patients treated with olezarsen achieved triglyceride levels below 500 mg/dL, the risk threshold for acute pancreatitis. The data was presented at the American Heart Association Scientific Sessions and published in The New England Journal of Medicine. Ionis plans to submit a supplemental new drug application to the FDA by the end of the year.

Items reported

Item 7.01

Regulation FD Disclosure

Regulation FD Disclosure
Item 8.01

Other Events

Product Launch

Market reaction

Close before filing

$73.55

Next session

-1.5%

Since filing

-29.6%

Latest close

$51.77

What happened, not what will happen — closing prices around the filing date.

Precedent

Previous filings from IONS reporting the same item, with the next session's move:

About Ionis Pharmaceuticals Inc.

Ionis Pharmaceuticals Inc. is a biotechnology company focused on discovering and developing RNA-targeted therapeutics. The primary mission of Ionis is to harness its expertise in antisense oligonucleotide technology to address complex genetic disorders. Ionis is pioneering in the field of RNA-targeted drug discovery, aiming to treat a wide range of diseases, including neurological, cardiovascular, metabolic, and cancer-related conditions. Notably, the company has a robust pipeline of drugs in various stages of development and partnerships with leading pharmaceutical companies to expand the reach and impact of its therapeutic discoveries. As an innovative entity in the biotechnology sector, Ionis Pharmaceuticals plays a significant role in advancing medical treatments that target the underlying genetic causes of diseases, thereby offering new hope and potential solutions to patients worldwide. Its advancements contribute substantially to the growth and evolution of personalized medicine, emphasizing the importance of genetic research in modern healthcare.

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