CalciMedica discontinues Phase 2 KOURAGE trial of Auxora in AKI after IDMC safety concern

CalciMedica, Inc.

IDMC identified a safety concern requiring re-evaluation of study design, particularly enrollment criteria.
No treatment-related deaths or SAEs requiring expedited FDA reporting in the trial.
Company plans comprehensive review of unblinded data to inform possible future AKI trials.
CEO reaffirms optimism for Auxora in acute pancreatitis; pivotal trial design expected H1 2026.
Also advancing second CRAC inhibitor CM5480 for pulmonary arterial hypertension.

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