Intellia暂停了第3阶段的试验,原因是病人肝毒性严重,导致林业发展局的临床搁置和40%的库存量下降。
Intellia paused its Phase 3 trials due to severe liver toxicity in a patient, prompting an FDA clinical hold and a 40% stock drop.
在MAGNITUDE试验中,一名病人患有严重的肝毒性,触发了协议规定的停产,此后,Intellia 治疗学暂停了对Nexiguran ziclumeran的第三阶段试验。
Intellia Therapeutics paused its Phase 3 trials for nexiguran ziclumeran after a patient in the MAGNITUDE trial suffered severe liver toxicity, triggering a protocol-defined halt.
由于发生严重的不良事件,FDA暂停了这两项临床试验,其中包括4级肝转氨酶升高和胆红素升高.
The FDA placed a clinical hold on both trials following a serious adverse event involving Grade 4 liver transaminase elevation and elevated bilirubin.
新闻导致Intellia的股票急剧下降,两天内股票下跌超过40%。
The news caused Intellia’s stock to drop sharply, with shares falling over 40% in two days.
该公司正在与监管者合作解决安全问题,但没有提供恢复审判的时间表。
The company is working with regulators to address safety concerns, but no timeline for resuming trials has been provided.