Olezarsen liver fat study data highlighted by Ionis (NASDAQ: IONS)

Rhea-AI Filing Summary

Ionis Pharmaceuticals reported new clinical data for its experimental drug olezarsen in people with severe hypertriglyceridemia, a condition marked by very high blood fats. The company shared what it described as positive results from an ongoing extension of its CORE and CORE2 studies at a major lipid conference in Chicago.

The update focused on liver fat measurements using MRI technology in 53 patients who completed 12 months of treatment in the CORE open-label extension, all on an 80 mg dose of olezarsen. These patients represented about 25% of those enrolled in a dedicated liver fat substudy, which tracks hepatic fat fraction over time.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Key Figures

Patients with MRI-PDFF data: 53 patients Treatment duration: 12 months Substudy share of patients: 25% +1 more

4 metrics

Patients with MRI-PDFF data 53 patients Completed 12 months of treatment in CORE-OLE

Treatment duration 12 months CORE-OLE olezarsen treatment period for reported MRI-PDFF results

Substudy share of patients 25% Approximate portion of MRI-PDFF substudy patients represented by the 53 reported

Olezarsen dose 80 mg Dose received by all patients during the CORE-OLE extension

Key Terms

open-label extension, severe hypertriglyceridemia, MRI-PDFF, hepatic fat fraction, +1 more

5 terms

open-label extension medical

"shared positive new data from the open-label extension study of CORE and CORE2"

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

severe hypertriglyceridemia medical

"evaluating olezarsen in people with severe hypertriglyceridemia"

An extreme elevation of triglycerides, the fat particles carried in the blood, that can overwhelm the body’s ability to process them and sharply raise the risk of acute pancreatitis and other complications. Think of blood as a river and triglycerides as oil — when levels get too high the flow and nearby organs can be damaged. Investors care because it drives demand for treatments, affects clinical trial safety and regulatory review, and can influence healthcare costs, reimbursement and company valuations.

MRI-PDFF medical

"longer-term hepatic magnetic resonance imaging-proton density fat fraction"

MRI-PDFF (Magnetic Resonance Imaging-Proton Density Fat Fraction) is a medical imaging technique that measures the amount of fat within the liver or other tissues. For investors, it provides a precise way to assess health risks related to fat buildup, which can impact healthcare costs and the valuation of related companies. Its accuracy helps in monitoring treatment progress and predicting potential medical expenses, making it relevant for healthcare decision-making and investment considerations.

hepatic fat fraction medical

"to evaluate hepatic fat fraction over time by serial MRI assessments"

National Lipid Association Scientific Sessions medical

"during an oral presentation at the National Lipid Association Scientific Sessions in Chicago"

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Understanding 8-K Material Events →

false000087401500008740152026-06-122026-06-12

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported):  June 12, 2026

IONIS PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in Charter)

Delaware

(State or Other Jurisdiction of Incorporation)

000-19125		33-0336973
(Commission File No.)		(IRS Employer Identification No.)

2855 Gazelle Court

Carlsbad, CA 92010

(Address of Principal Executive Offices and Zip Code)

Registrant’s telephone number, including area code: (760) 931-9200

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading symbol		Name of each exchange on which registered
Common Stock, $.001 Par Value		“IONS”		The Nasdaq Stock Market, LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (Section 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (Section 240.12b-2 of this chapter).

  Emerging growth company              ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

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:

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

• 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.

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

• 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.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
104	Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	Ionis Pharmaceuticals, Inc.
Dated:  June 12, 2026	By:	/s/ Patrick R. O’Neil
		Patrick R. O’Neil
		Executive Vice President, Chief Legal Officer and General Counsel

FAQ

What did Ionis Pharmaceuticals (IONS) announce regarding olezarsen on June 12, 2026?

Ionis Pharmaceuticals announced new positive data for olezarsen from the open-label extension of its CORE and CORE2 studies in severe hypertriglyceridemia. The results were presented at the National Lipid Association Scientific Sessions in Chicago, highlighting longer-term liver fat imaging outcomes.

What patient group was evaluated in Ionis (IONS) CORE-OLE olezarsen study?

The CORE-OLE study evaluated olezarsen in people with severe hypertriglyceridemia, a condition characterized by very high triglyceride levels. A subset of these patients with elevated liver fat at baseline was followed over time to assess changes in hepatic fat using MRI-based imaging techniques.

How many patients were included in the MRI-PDFF analysis in Ionis (IONS) CORE-OLE?

Ionis reported hepatic MRI-PDFF results from 53 patients who completed 12 months of olezarsen treatment in the CORE-OLE study. These 53 participants represented about 25% of the patients enrolled in the MRI-PDFF liver fat substudy drawn from CORE and CORE2.

What dose of olezarsen was used in the Ionis (IONS) CORE-OLE extension study?

During the CORE-OLE extension study, all patients received an 80 mg dose of olezarsen. This uniform dosing allowed investigators to assess longer-term effects on severe hypertriglyceridemia and associated measures like hepatic fat fraction under consistent treatment conditions over 12 months.

Where did Ionis Pharmaceuticals (IONS) present the new olezarsen data?

Ionis presented the new olezarsen data at the National Lipid Association Scientific Sessions held in Chicago. The oral presentation covered positive findings from the CORE-OLE open-label extension, including MRI-based liver fat results in patients with severe hypertriglyceridemia receiving 80 mg olezarsen.

Filing Exhibits & Attachments

3 documents

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.8 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 21.5 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 15.7 KB