Intellia：FDA 對 nex-z 的 MAGNITUDE/MAGNITUDE-2 第三期試驗發出臨床暫停令

FDA 於 2025 年 10 月 29 日對 nex-z 的 MAGNITUDE 與 MAGNITUDE-2 第三期試驗的 IND 申請發出臨床暫停令，原因為一名患者死亡並出現 4 級肝轉氨酶升高。Intellia 已暫停 nex-z 的里程碑指引，待與監管機構達成一致後再行更新，並正與研究者合作制定風險緩解計畫。

關鍵事實

申報時間: 2025年11月6日下午09:06
事件: 臨床試驗登錄異動
方向: 負面
公司: NTLAIntellia
資產: nexiguran ziclumeran
來源: SEC 8-K
可信度: 有出處

來源摘錄

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