原始出處紀錄
重大申請已送件
Corcept 重新提交 relacorilant 用於庫欣氏症候群的 NDA
Corcept 已針對 FDA 要求的額外分析完成後，重新提交 relacorilant 用於庫欣氏症候群的 NDA。重新提交啟動六個月審查時程。此申請獲得 GRACE 與 GRADIENT 第三期試驗及長期延伸數據支持。
關鍵事實
- 申報時間
- 2026年6月17日 下午08:36
- 事件
- 申請已送件
- 方向
- 中性
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
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