Stoke Therapeutics, Inc. 宣布,其用于治疗Dravet综合征的在研药物Zorevunersen的III期EMPEROR研究已完成患者入组工作,共计招募162名患者。该公司计划于2027年第一季度启动向美国食品药品监督管理局(FDA)滚动提交新药申请(NDA)的程序。关键的III期临床数据预计将在2027年第三季度读出,并计划在2027年下半年完成NDA的全部提交。值得注意的是,在该III期EMPEROR研究中,目前尚无患者中止治疗。
Stoke Therapeutics, Inc. 宣布,其用于治疗Dravet综合征的在研药物Zorevunersen的III期EMPEROR研究已完成患者入组工作,共计招募162名患者。该公司计划于2027年第一季度启动向美国食品药品监督管理局(FDA)滚动提交新药申请(NDA)的程序。关键的III期临床数据预计将在2027年第三季度读出,并计划在2027年下半年完成NDA的全部提交。值得注意的是,在该III期EMPEROR研究中,目前尚无患者中止治疗。
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