Ionis Pharmaceuticals Files 8-K

Ticker: IONS · Form: 8-K · Filed: Nov 10, 2025 · CIK: 874015

Sentiment: neutral

Topics: 8-K, disclosure, regulation-fd

TL;DR

IONIS filed an 8-K, standard disclosure, no major news yet.

AI Summary

On November 8, 2025, Ionis Pharmaceuticals, Inc. filed an 8-K report. The filing primarily concerns other events and regulation FD disclosures, with no specific material events or financial updates detailed in the provided text. The report was filed on November 10, 2025.

Why It Matters

This 8-K filing indicates Ionis Pharmaceuticals is making disclosures to the SEC, which is standard practice for publicly traded companies. The specific content of the disclosure is not detailed in the provided excerpt.

Risk Assessment

Risk Level: low — The filing is a routine 8-K report with no immediately apparent negative or positive material information disclosed in the provided text.

Key Players & Entities

FAQ

What is the primary purpose of this 8-K filing for Ionis Pharmaceuticals?

The filing is primarily for Regulation FD Disclosure and Other Events, as indicated by the Item Information section.

When was the earliest event reported in this filing?

The earliest event reported was on November 8, 2025.

On what date was this 8-K form filed with the SEC?

The 8-K form was filed on November 10, 2025.

What is the principal executive office address for Ionis Pharmaceuticals?

The principal executive office is located at 2855 Gazelle Court, Carlsbad, CA 92010.

What is the Commission File Number for Ionis Pharmaceuticals?

The Commission File Number for Ionis Pharmaceuticals is 000-19125.

Filing Stats: 1,537 words · 6 min read · ~5 pages · Grade level 12.4 · Accepted 2025-11-10 06:04:26

Filing Documents

01

Item 7.01 Regulation FD Disclosure. On November 8, 2025, Ionis Pharmaceuticals, Inc. ("Ionis," "we," "us" or "our company") issued a press release announcing positive results from the pivotal Phase 3 CORE and CORE2 studies of olezarsen in people with severe hypertriglyceridemia ("sHTG"). A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information in this Item 7.01 and the exhibit attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.

01

Item 8.01 Other Events. On November 8, 2025, we announced positive results from the pivotal Phase 3 CORE and CORE2 studies of olezarsen in people with sHTG. The studies met the primary endpoint, with olezarsen achieving a highly statistically significant placebo-adjusted mean reduction in fasting triglyceride (TG) levels of up to 72% at six months. The reductions were sustained through 12 months. Olezarsen showed a highly statistically significant 85% reduction in acute pancreatitis events, the first and only time achieved in sHTG. Additionally, 86% of olezarsen-treated patients achieved triglyceride levels less than 500 mg/dL, below the risk threshold for acute pancreatitis. Olezarsen demonstrated favorable safety and tolerability. These data were presented during a late-breaking session at the American Heart Association Scientific Sessions, taking place November 7-10 in New Orleans, and simultaneously published in The New England Journal of Medicine . Nearly 1,100 patients were enrolled in the CORE and CORE2 studies, which is the largest pivotal program ever conducted in sHTG, and patients were required to be on standard of care lipid-lowering therapy. The CORE and CORE2 studies met the primary endpoint across doses, with olezarsen demonstrating an up to 72% (p<0.001) placebo-adjusted mean reduction in fasting triglyceride levels at six months. The reductions were sustained through 12 months. Additionally, among patients with baseline levels above these thresholds at 12 months: TGs <880 mg/dL: 89% and 88% of patients on olezarsen 50 mg and 80 mg, respectively, achieved triglyceride levels less than 880 mg/dL, the level associated with the highest risk of acute pancreatitis. TGs <500 mg/dL: 86% of patients on olezarsen 50 mg and 80 mg achieved triglyceride levels less than 500 mg/dL, below the risk threshold for sHTG and acute pancreatitis. TGs <150 mg/dL: 34% and 54% of patients on olezarsen 50 mg and 80 mg, respectively, achieved normal triglyceride lev

Forward-Looking Statements

Forward-Looking Statements Certain statements contained in this report are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include, without limitation, statements regarding Ionis' business, the therapeutic and commercial potential of olezarsen, our commercial medicines, additional medicines in development and technologies, and Ionis' expectations regarding development and regulatory milestones. Words such as "anticipate," "believe," "could," "continue," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. For such statements, Ionis claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Ionis' expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, risks and uncertainties including those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Ionis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Additional factors that could cause actual results to differ materially from those stated or implied by Ionis' forward-looking statements are disclosed in Ionis' filings with the Securities and Exchange Commission, including in the section captioned "Risk Factors" in Ionis' most recent Annual Report on Form 10-K and subsequently filed Quarterly Reports on For

forward-looking statements, other than as may be required under applicable law

forward-looking statements, other than as may be required under applicable law.

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 Press Release dated November 8, 2025. 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: November 10, 2025 By: /s/ Patrick R. O'Neil Patrick R. O'Neil Executive Vice President, Chief Legal Officer and General Counsel

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