1차 출처 기록
중대제조시설 실사
Intellia: FDA, MAGNITUDE 3상 ATTR-CM 시험에 대한 임상 보류 해제
FDA가 ATTR-CM 대상 nex-z의 MAGNITUDE 3상 IND에 대한 임상 보류를 해제했습니다. 등록 재개를 위해 강화된 간 모니터링, 단기 스테로이드 지침, 심혈관 불안정 및 낮은 박출률에 대한 추가 제외 기준이 합의되었습니다.
핵심 사실
출처 발췌
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