异动解读|Celcuity盘中上涨5.22%,FDA关键审评日临近催化市场预期

行情直击
Jul 15

7月15日,Celcuity盘中上涨5.22%,报109.21美元/股,成交额1.0亿美元。

消息面上,FDA此前已受理Celcuity核心候选药物gedatolisib的新药申请并授予优先审评资格,PDUFA目标审评日期定于7月17日,距当前仅两日。市场对该药获批前景的乐观预期推动股价走强。

此前公布的III期Viktoria-1试验数据显示,gedatolisib三联疗法将疾病进展或死亡风险降低50%,中位无进展生存期达11.1个月,远超对照组的5.6个月,客观缓解率分别为48.9%和35.7%,安全性整体良好。公司已完成5亿美元可转换票据融资以支持商业化准备,并将III期Viktoria-2试验扩展至内分泌敏感患者群体。

(以上内容均基于市场公开消息,由程序或算法智能生成,仅作为股价异动提醒,不作为投资建议或交易依据。)

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10