BUZZ-Replimune 在 FDA 拒绝批准黑色素瘤药物后暴跌

路透中文
Apr 11
BUZZ-Replimune 在 FDA 拒绝批准黑色素瘤药物后暴跌

4月10日 - ** 生物技术公司Replimune REPL.O的股票在延时交易中下跌59%,至1.98美元

** 美国食品和药物管理局说,它拒绝批准 (link) REPL 公司治疗晚期黑色素瘤(一种严重的皮肤癌)的实验性疗法

** FDA称两项研究的数据不足以支持批准该疗法与百时美施贵宝BMY.N的Opdivo联合使用

** 监管机构称,该申请主要依赖于单臂研究,因此很难分离出该药物在联合使用时的益处

** 首席执行官苏希尔-帕特尔(Sushil Patel)表示,公司别无选择,只能裁员并大幅缩减在美国的生产业务

** 在周五发布公告之前,REPL 股票停止交易

** 股价年累计下跌约 51%

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