Ionis: CORE/CORE2 3상 olezarsen sHTG topline – TG 72% 감소, 췌장염 85% 감소

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.

핵심 사실

제출: 2025년 11월 10일 AM 11:04
이벤트: 탑라인 결과
방향: 긍정적
기업: IONS아이오니스
자산: olezarsen
출처: SEC 8-K
신뢰도: 출처 확인
캘린더: FDA 심사 결정 (PDUFA) · 2026년 6월 30일 · 긍정적
전체 NNT: 20
최고 위험군 NNT: 4
TG 500 mg/dL 미만: 86%
급성 췌장염 감소: 85%
위약 조정 TG 감소: 최대 72%

출처 발췌

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