{"url_path":"/sec/ions/8-k/2026-06-24/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 Other Events.","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-06-24","source_url":"https://www.sec.gov/Archives/edgar/data/874015/0001140361-26-026232-index.html","accession_number":"0001140361-26-026232","cik":"0000874015","ticker":"IONS","issuer_name":"IONIS PHARMACEUTICALS INC","edgar_url":"https://www.sec.gov/Archives/edgar/data/874015/0001140361-26-026232-index.html","primary_entity_key":"0000874015","primary_entity_name":"IONIS PHARMACEUTICALS INC"},"word_count":512,"has_tables":true,"body_markdown":"Item 8.01          Other Events.\n\nOn June 24, 2026, Ionis announced that the U.S. FDA has approved TRYNGOLZA® (olezarsen) as an adjunct to diet to reduce triglycerides and the risk of acute\npancreatitis in adults with sHTG. TRYNGOLZA is available in a 50 mg or 80 mg dose and is self-administered once monthly via an autoinjector. sHTG is characterized by an increased risk of acute pancreatitis, which causes debilitating abdominal pain\nthat often leads to repeated and prolonged hospitalization, permanent organ damage and can be life-threatening.\n\nThe FDA approval was based on positive results from the Phase 3 CORE and CORE2 studies, which were published in The New England Journal of Medicine.\n\nIn the CORE and CORE2 studies, TRYNGOLZA demonstrated rapid and consistent triglyceride control, lowering fasting triglyceride levels by up to 72% compared to placebo\nat six months and sustaining those reductions at 12 months. Additionally, TRYNGOLZA significantly reduced acute pancreatitis events by up to 91%. Among patients treated with TRYNGOLZA with baseline and 12-month data, 86% achieved triglyceride\nlevels below 500 mg/dL, a critical threshold for reducing acute pancreatitis risk. The number needed to treat (“NNT”) over one year to\nprevent one episode of acute pancreatitis was 20 in the overall cohort and four in patients with triglycerides ≥880 mg/dL and a prior history of acute pancreatitis, indicating a strong clinical benefit across the spectrum of sHTG patients and an\nexceptional clinical benefit in the highest risk subgroup.\n\nAcross the clinical program, TRYNGOLZA demonstrated a favorable safety and tolerability profile. The most common adverse reactions in patients with sHTG (incidence ≥2%\nhigher than placebo) were injection site reactions and liver enzyme increases.\n\nTRYNGOLZA will be available for sHTG in the U.S. in July.\n\nForward-Looking Statements\n\nThis report includes forward-looking statements regarding Ionis’ business and the therapeutic and commercial potential of TRYNGOLZA, Ionis’ technologies and other\nproducts in development. Any statement describing Ionis’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain\nrisks 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.\nIonis’ 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. Although Ionis’\nforward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. Except as required by law, Ionis undertakes no obligation to update any forward-looking\nstatements for any reason. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis’ programs are described in additional detail in Ionis’ annual report on Form 10-K for the year ended\nDecember 31, 2025, and most recent Form 10-Q, which are on file with the Securities and Exchange Commission. Copies of these and other documents are available from the Company."}