原始来源记录

重大生产设施检查

Intellia:FDA 解除 MAGNITUDE 3 期 ATTR-CM 试验的临床暂停

FDA 已解除 nex-z 用于 ATTR-CM 的 MAGNITUDE 3 期 IND 临床暂停。已就加强肝功能监测、短期类固醇指导以及新增心血管不稳定和低射血分数排除标准达成一致,以恢复入组。

关键事实

申报时间
2026年3月2日 13:16
事件
生产设施检查
方向
积极
来源
SEC 8-K
可信度
有来源

来源摘录

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

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