原始来源记录
重大生产设施检查
CalciMedica：FDA完成安全审查后批准KOURAGE试验恢复
FDA已完成对KOURAGE方案修订版及中期安全数据的审查，未提出任何意见或问题，确认试验可恢复给药。该审查并非正式的临床暂停回复，但验证了修订后的设计和安全包。CalciMedica另预计FDA将于2026年第三季度反馈急性胰腺炎潜在关键项目的意见。
关键事实
来源摘录
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