异动解读|Celcuity盘中上涨5.02%,核心药物FDA审评目标日期临近

行情直击
Jul 08

7月8日,Celcuity盘中上涨5.02%,报114.03美元/股,成交额5562.87万美元。

消息面上,公司核心候选药物gedatolisib的FDA处方药用户付费法案(PDUFA)目标审评日期定于7月17日,距今仅约一周。该药物此前已获FDA新药申请优先审评资格,用于HR+/HER2-/PIK3CA突变晚期乳腺癌治疗。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,较对照组5.6个月近乎翻倍。市场对即将到来的FDA审批决定持乐观预期,推动股价走强。

(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。)

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