Intellia：FDA解除MAGNITUDE-2 III期ATTRv-PN试验的临床搁置

FDA已解除nex-z在ATTRv-PN的MAGNITUDE-2 III期IND临床搁置，允许恢复患者入组和给药。公司已与FDA就加强肝脏安全性监测达成一致，并将目标入组人数从约50人增至约60人。针对MAGNITUDE ATTR-CM试验的单独临床搁置仍在继续沟通。

关键事实

申报时间: 2026年1月27日 13:19
事件: 临床试验登记变更
方向: 积极
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 d29201dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Intellia Therapeutics Announces FDA Lift of Clinical Hold on MAGNITUDE-2 Phase 3 Clinical Trial in ATTRv-PN • Plan to resume MAGNITUDE-2 patient enrollment and dosing • FDA engagement ongoing regarding clinical hold on MAGNITUDE Phase 3 clinical trial in ATTR-CM CAMBRIDGE, Mass., Jan. 27, 2026 – Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on the Investigational New Drug application (IND) for the MAGNITUDE-2 Phase 3 clinical trial of nexiguran ziclumeran (nex-z) for patients with hereditary transthyretin amyloidosis with poly

SEC 8-K