Intellia：FDA 解除 MAGNITUDE-2 第三期 ATTRv-PN 試驗的臨床暫停

FDA 已解除 nex-z 用於 ATTRv-PN 的 MAGNITUDE-2 第三期 IND 臨床暫停，允許恢復患者招募與給藥。公司已與 FDA 就加強肝臟安全性監測達成共識，並將目標招募人數從約 50 人增加至約 60 人。針對 MAGNITUDE ATTR-CM 試驗的另一項臨床暫停，持續與 FDA 進行溝通。

關鍵事實

申報時間: 2026年1月27日下午01:19
事件: 臨床試驗登錄異動
方向: 正面
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 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