原始来源记录
重大申请已提交
Corcept 重新提交 relacorilant 治疗库欣综合征的 NDA
Corcept 在完成 FDA 要求的额外分析后，重新提交了 relacorilant 治疗库欣综合征的 NDA。此次重新提交启动了六个月的审查周期。该申报材料由 GRACE 和 GRADIENT 3 期试验以及长期扩展数据支持。
关键事实
- 申报时间
- 2026年6月17日 20:36
- 事件
- 申请已提交
- 方向
- 中性
- 来源
- SEC 8-K
- 可信度
- 有来源
来源摘录
EX-99.1 2 d159941dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 CONTACT: Investor inquiries: ir@corcept.com Media inquiries: communications@corcept.com www.corcept.com Corcept Resubmits New Drug Application for Relacorilant as a Treatment for Patients with Cushing’s Syndrome REDWOOD CITY , Calif., (June 17, 2026) — Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for relacorilant as a treatment for patients with Cushing’s syndrome. As requested by the FDA, the resubmi