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07-08

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。）

免责声明：本文观点仅代表作者个人观点，不构成本平台的投资建议，本平台不对文章信息准确性、完整性和及时性做出任何保证，亦不对因使用或信赖文章信息引发的任何损失承担责任。

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