原始出處紀錄

重大製造廠查核

Intellia:FDA 解除 MAGNITUDE 第三期 ATTR-CM 試驗的臨床暫停

FDA 已解除 nex-z 用於 ATTR-CM 的 MAGNITUDE 第三期 IND 臨床暫停。已同意加強肝功能監測、短期類固醇指引,以及新增心血管不穩定與低射血分數的排除標準,以恢復收案。

關鍵事實

申報時間
2026年3月2日 下午01:16
事件
製造廠查核
方向
正面
來源
SEC 8-K
可信度
有出處

來源摘錄

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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