美国食品药品监督管理局建议在提交上市申请前进行新的临床试验,Compass股价应声下跌

路透中文
Sep 22
BUZZ-<a href="https://laohu8.com/S/USFD">美国食品</a>药品监督管理局建议在提交上市申请前进行新的临床试验,Compass股价应声下跌

9月22日 - ** Compass Therapeutics(CMPX.O)股价在盘前交易中下跌40.8%,至1.51美元

** 该公司表示,美国食品药品监督管理局(FDA)建议在为其实验性药物托维西米格(tovecimig)提交上市申请前,先进行一项新试验以证明该药对生存期的获益

** Tovecimig 目前正在晚期胆道癌患者中进行临床试验,这是一种起源于胆管或胆囊的罕见且侵袭性强的恶性肿瘤

** 基于其中期至后期临床试验结果以及患者迫切未满足的医疗需求,Compass表示认为在提交上市申请前无需进行新的临床试验

** 该公司表示,计划与美国食品药品监督管理局(FDA)进一步沟通

** 截至上一交易日收盘,该公司股票今年以来累计下跌66%

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