原始出處紀錄
重大製造廠查核
CalciMedica：FDA 完成 KOURAGE 試驗安全性審查，同意恢復招募
FDA 已完成對 KOURAGE 試驗方案修正案及中期安全性資料的審查，未提出任何意見或問題，確認試驗可恢復給藥。此次審查並非正式臨床暫停回覆，但驗證了修正後的設計與安全性資料包。CalciMedica 另預期 FDA 將於 2026 年第三季就急性胰臟炎潛在關鍵性試驗計畫提供回饋。
關鍵事實
來源摘錄
EX-99.1 6 d142943dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 CalciMedica Announces Clinical Development of Auxora May Proceed Following FDA Review of KOURAGE Trial Interim Safety Data FDA reviewed a protocol amendment and interim safety data from the KOURAGE trial evaluating Auxora in AKI patients No comments or questions were received Confirms CalciMedica’s ability to continue clinical development of Auxora across indications LA JOLLA, Calif., June 24, 2026 – CalciMedica, Inc. (“CalciMedica” or the “Company”) (Nasdaq: CALC), a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for serious inflammatory, immunologic, and cardiopulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) ha