热门话题-美国FDA支持重新提交抗癌药物申请,Atara股价大涨

路透中文
May 07
热门话题-美国FDA支持重新提交抗癌药物申请,Atara股价大涨

5月7日 - ** Atara Biotherapeutics ATRA.O 股价上涨43%,至7.39美元

** 该公司与美国食品药品监督管理局(FDA)会面,商讨如何重启其抗癌药物塔贝克鲁塞尔(tabelecleucel)的申请

** Atara表示,FDA同意一项包含历史对照组的单臂研究足以支持新的申请

** 监管机构于1月拒绝批准 (link) 的塔贝克鲁塞尔(tabelecleucel),这是继此前因生产检查问题驳回该疗法后,第二次遭到拒绝

** 合作伙伴皮埃尔·法布尔制药公司计划重新提交申请,其中将包含来自其晚期临床试验的最新患者数据及更长的随访期

** Atara预计将在第三季度发布进一步的监管进展

** 今年以来股价累计下跌71%

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