Capricor股价暴跌,因FDA专家委员会就杜氏肌营养不良症细胞疗法召开会议,加剧了市场对风险的担忧

路透中文
Jun 26
BUZZ-Capricor股价暴跌,因FDA专家委员会就杜氏肌营养不良症细胞疗法召开会议,加剧了市场对风险的担忧

6月26日 - ** Capricor TherapeuticsCAPR.O)股价暴跌14%,至26.17美元

** Capricor表示,美国食品药品监督管理局(FDA)将于7月29日召开咨询委员会 (link) 会议,审议其用于治疗杜氏肌营养不良症(一种遗传性疾病)患者心肌病的细胞疗法deramiocel

** B. Riley证券分析师麦迪逊·埃尔-萨阿迪表示,股价的反应反映了与咨询委员会相关的“渐增的监管风险”

** 美国食品药品监督管理局(FDA)去年以缺乏疗效数据为由,拒绝批准 (link) 该药物,并要求提供更多数据

** Capricor公司去年12月表示,在一项晚期临床试验中,与安慰剂相比,deramiocel显著 (link) 减缓了患者肌肉和心脏功能的衰退

** 埃尔-萨阿迪表示,咨询委员会的这一决定“并不令人意外”,重点应放在数据的可靠性上

** 预计美国食品药品监督管理局(FDA)将于8月22日前就该申请作出决定

** 算上本次交易,该股今年以来累计下跌10%

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