IDEAYA Biosciences飙涨逾40%!因眼癌药物组合试验达到主要目标并计划提交新药申请

异动解读
Apr 13

4月13日,IDEAYA Biosciences(IDYA)今日盘前股价一度飙涨逾40%,引起了市场的广泛关注。

消息面上,该公司宣布其与施维雅(Servier)合作开发的Darovasertib与克唑替尼(Xalkori)组合疗法,在一线治疗HLA-A*02:01阴性转移性葡萄膜黑色素瘤的2/3期注册临床试验(OPTIMUM-02)中取得了积极的顶线结果,成功达到了主要研究终点。

独立中心影像评估确认,该组合疗法在主要疗效指标——中位无进展生存期方面展现出具有统计学意义的显著改善。具体数据显示,联合治疗组的中位生存期提高了6.9个月,而对照组仅为3.1个月,并且观察到了完全缓解病例。基于这些积极数据,公司计划在2026年下半年向美国食品药品监督管理局(FDA)提交新药申请,寻求加速批准路径。

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