Intellia: FDA、ATTR-CMを対象としたMAGNITUDE第3相試験の臨床保留を解除

FDAはATTR-CMを対象としたnex-zのMAGNITUDE第3相INDに対する臨床保留を解除した。登録再開に向け、肝機能モニタリングの強化、短期ステロイド投与に関する指針、心血管不安定性および低駆出率に対する追加除外基準が合意された。

主要事実

提出: 2026年3月2日 13:16
イベント: 製造施設の査察
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 3 d101756dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 AMENDMENT NO. 2 TO THE OPEN MARKET SALE AGREEMENT SM March 2, 2026 JEFFERIES LLC 520 Madison Avenue New York, New York 10022 Ladies and Gentlemen: This Amendment No. 2 to the Open Market Sale Agreement SM , dated as of March 2, 2026, is entered into by and between Intellia Therapeutics, Inc. (the “ Company ”) and Jefferies LLC (the “ Agent ”). Capitalized terms used but not otherwise defined herein shall have the respective meanings ascribed to them in the Sales Agreement (as defined below). WHEREAS, the Company and the Agent have entered into that certain Open Market Sale Agreement SM , dated March 4, 2022, as amended by that certain Amendment to the Open Market Sale Agreement SM , dated as of February 23, 2024 (the “ Sales A

SEC 8-K