Ionis Pharmaceuticals Inc.

06/12/2026 | Press release | Distributed by Public on 06/12/2026 12:20

Material Event (Form 8-K)

Item 8.01
Other Events.
On June 12, 2026, Ionis Pharmaceuticals, Inc. ("Ionis") shared positive new data from the open-label extension study of CORE and CORE2 ("CORE-OLE") evaluating olezarsen in people with severe hypertriglyceridemia ("sHTG") during an oral presentation at the National Lipid Association Scientific Sessions in Chicago. The presentation included new, longer-term hepatic magnetic resonance imaging-proton density fat fraction ("MRI-PDFF") results from 53 patients who completed 12 months of treatment in the CORE-OLE, representing approximately 25% of patients enrolled in the MRI-PDFF substudy. The substudy enrolled a subset of patients from CORE and CORE2 with elevated liver fat at baseline to evaluate hepatic fat fraction ("HFF") over time by serial MRI assessments. During the CORE-OLE, all patients received the 80 mg dose of olezarsen. Key findings from the presentation include:


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Mean HFF levels returning toward baseline, after 24 months of treatment with the 80 mg dose of olezarsen.

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Mean changes in HFF levels were less pronounced in patients who transitioned from the 50 mg dose in the randomized, double-blind, placebo-controlled portion of the studies to the 80 mg dose in the CORE-OLE.

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Olezarsen continued to demonstrate a favorable safety profile with longer-term treatment.

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Patient retention in the CORE-OLE has been very high, with more than 90% of eligible patients who completed the CORE and CORE2 studies transitioning into and remaining in the CORE-OLE.

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