Intellia：FDA对nex-z的MAGNITUDE/MAGNITUDE-2 III期试验实施临床暂停

FDA于2025年10月29日对nex-z的MAGNITUDE和MAGNITUDE-2 III期试验IND申请实施临床暂停，此前一名患者死亡并出现4级肝转氨酶升高。Intellia已暂停nex-z的里程碑指引，等待监管协调，并正与研究者合作制定风险缓解计划。

关键事实

申报时间: 2025年11月6日 21:06
事件: 临床试验登记变更
方向: 消极
公司: NTLAIntellia
资产: nexiguran ziclumeran
来源: SEC 8-K
可信度: 有来源

来源摘录

EX-99.1 2 d53244dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Intellia Therapeutics Announces Third Quarter 2025 Financial Results and Recent Updates • Awaiting FDA clinical hold letter on MAGNITUDE and MAGNITUDE-2 clinical trials of nex-z • Presenting longer-term Phase 1 clinical data of nex-z for ATTR-CM on November 10 at AHA 2025; previously published longer -term Phase 1 clinical data for nex-z for ATTRv-PN in New England Journal of Medicine • Completed enrollment in Phase 3 HAELO clinical trial of lonvo-z for HAE; topline data expected by mid-2026 with potential U.S. commercial launch in 1H27 • Presenting longer-term Phase 1/2 clinical data of lonvo-z on November 8 at ACAAI 2025 • Ended third quarter with approximately $670 million in cash, cash equivalents and marketable secu

SEC 8-K