Intellia: FDAがMAGNITUDE-2第3相ATTRv-PN試験の臨床試験一時停止を解除

FDA removed the clinical hold on the MAGNITUDE-2 Phase 3 IND for nex-z in ATTRv-PN, allowing patient enrollment and dosing to resume. The company has aligned with FDA on enhanced liver-safety monitoring and increased target enrollment from ~50 to ~60 patients. Engagement continues on the separate clinical hold for the MAGNITUDE ATTR-CM trial.

主要事実

提出: 2026年1月27日 13:19
イベント: 試験登録の変更
方向: ポジティブ
企業: NTLAインテリア
アセット: nexiguran ziclumeran
出典: SEC 8-K
信頼度: 出典あり

出典の抜粋

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