Biopharma · FDA Approvals · Stock
CalciMedica Inc is a clinical-stage biopharmaceutical company focused on developing therapeutics that treat serious illnesses driven by inflammatory and immunologic processes and direct cellular damage. Its product candidates act upon calcium release-activated calcium (CRAC) channels and would constitute a new class of…
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CalciMedica: FDA clears KOURAGE trial to resume after safety review
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.
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