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Sundry Photography Gilead (NASDAQ:GILD) has decided to discontinue further studies on its anti-CD47 immunotherapy candidate magrolimab in blood cancer after a Phase 3 trial indicated an increased risk of death, the company announced Wednesday. The Foster City, California-based biotech also disclosed that the FDA placed all magrolimab studies in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) under full clinical hold.
杂项摄影Gilead(纳斯达克股票代码:GILD)周三宣布,该公司已决定停止对其抗CD47免疫治疗候选药物magrolimab在血癌中的进一步研究,因为该公司的3期试验表明死亡风险增加。总部位于加利福尼亚州福斯特城的生物技术公司还透露,FDA将所有针对急性骨髓性白血病(AML)和骨髓增生异常综合征(MDS)的马格单抗研究置于完全临床控制之下。
The decision follows early findings from its Phase 3 ENHANCE-3 study for magrolimab in AML and the ENHANCE and ENHANCE-2 trials in MDS and AML, respectively. Citing an analysis of an independent panel, the company said magrolimab as a combination therapy failed in ENHANCE-3 and raised mortality risk in patients mainly due to infections and respiratory failure.
该决定是根据其针对AML中马格单抗的3期增强-3研究以及分别针对MDS和AML的增强和增强-2试验的早期发现做出的。该公司援引一个独立小组的分析称,马格单抗作为一种联合疗法在增强-3中失败,并增加了患者的死亡风险,主要是由于感染和呼吸衰竭。
ENHANCE and ENHANCE-2 also indicated similar results with futility and an increased risk of death in the on-drug arm, Gilead (GILD) noted. Its ongoing solid tumor programs for magrolimab are also under review for safety, and the company expects to provide an update from that assessment in the near term.
Gilead(GILD)指出,Enhanced和Enhanced-2也显示出类似的结果,但徒劳且药物治疗组的死亡风险增加。其正在进行的马格单抗实体瘤项目也正在进行安全性审查,该公司预计将在近期提供该评估的最新信息。
Gilead (GILD) added magrolimab with its $4.9B acquisition of cancer drug developer Forty Seven in 2020. More on Gilead Sciences Gilead Sciences, Inc. (GILD) Q4 2023 Earnings Call Transcript Gilead Sciences, Inc. 2023 Q4 - Results - Earnings Call Presentation Gilead Sciences: The Sky Is Not Falling Gilead stock dips after hours amid lackluster 2024 sales forecast Gilead Sciences Non-GAAP EPS of $1.72 misses by $0.04, revenue of $7.12B beats by $20M .
吉利德(Gilead)于2020年斥资49亿美元收购了癌症药物开发公司四十七(Forty Seven),从而增加了马格单抗(magrolimab)。更多关于吉利德科学公司的信息吉利德科学公司(GILD)2023年第四季度收益通话记录吉利德科学公司2023年第四季度-结果-收益通话报告吉利德科学公司:由于2024年销售预测不佳,吉利德科学公司2024年非公认会计准则每股收益为1.72美元,未命中0.04美元,收入为71.2亿美元,超过2000万美元,因此吉利德科学公司股票数小时后并未下跌。