प्राथमिक स्रोत रिकॉर्ड
महत्वपूर्णविनिर्माण निरीक्षण
CalciMedica: सुरक्षा समीक्षा के बाद FDA ने KOURAGE ट्रायल को फिर शुरू करने की मंजूरी दी
FDA completed its review of the KOURAGE protocol amendment and interim safety data with no comments or questions, confirming the trial may resume dosing. The review was not a formal clinical-hold response but validates the revised design and safety package. CalciMedica separately expects FDA feedback on a potential pivotal program in acute pancreatitis in Q3 2026.
मुख्य तथ्य
स्रोत का अंश
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