Ionis: topline resulta ng Phase 3 CORE/CORE2 ng olezarsen sa sHTG – 72% pagbaba sa TG, 85% pagbawas sa pancreatitis

Pivotal Phase 3 CORE and CORE2 studies met primary endpoint with up to 72% placebo-adjusted TG reduction sustained to 12 months. Olezarsen also achieved the first-ever statistically significant 85% reduction in acute pancreatitis events in sHTG and 86% of patients reached TG <500 mg/dL. Ionis plans to file an sNDA for both 50 mg and 80 mg doses by year-end 2025.

Mahahalagang fact

Na-file: Nob 10, 2025, 11:04 AM
Kaganapan: Topline na resulta
Direksyon: Positibo
Kumpanya: IONSIonis
Asset: olezarsen
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Hun 30, 2026 · Positibo
Kabuuang NNT: 20
NNT sa pinakamataas na panganib: 4
TG na mas mababa sa 500 mg/dL: 86%
Pagbawas ng matinding pankreatitis: 85%
Pagbawas ng TG na naayos batay sa placebo: hanggang 72%

Sipi mula sa source

EX-99.1 2 ef20058520_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Groundbreaking pivotal study results of olezarsen for severe hypertriglyceridemia (sHTG) presented as a late breaker at AHA Scientific Sessions – Up to 72% placebo-adjusted mean reduction in fasting triglyceride levels at six months, with reductions sustained through 12 months – – 86% of olezarsen-treated patients achieved triglyceride levels less than 500 mg/dL, below the risk threshold for acute pancreatitis – – First and only investigational treatment for sHTG to significantly reduce acute pancreatitis events – – Data simultaneously published in The New England Journal of Medicine – – Ionis to host webcast today at 3:00 p.m. ET – CARLSBAD, Calif., Nov. 8, 2025 -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced

SEC 8-K