智通财经APP获悉，周三，Corcep医疗(CORT.US)股价暴跌超46%，报37.33美元。消息面上，该公司表示已收到美国食品药品监督管理局(FDA)发出的完整回应函，其新药申请未获批准。该申请旨在寻求批准口服药物Relacorilant用于治疗因皮质醇增多症(高皮质醇血症)引发的继发性高血压。
公司称，FDA在回应函中确认，Corcept的关键性GRACE临床试验达成主要终点，且GRADIENT试验数据具有验证性意义；但监管机构认为，现有资料仍不足以支持对该疗法作出有利的收益—风险评估，因而要求补充更多有效性证据。
对此，Corcept首席执行官Joseph K. Belanoff表示，公司“对这一结果感到意外和失望”，并称将“尽快与FDA会面，讨论并确定最佳的后续推进路径”。
资料显示，relacorilant为一种口服选择性糖皮质激素受体拮抗剂，除用于内源性皮质醇增多症相关适应症外，亦在卵巢癌等疾病领域开展研发。此次审批受挫意味着该药物的商业化进程将面临进一步不确定性，市场关注后续监管沟通及补充研究方案的推进情况。
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