CalciMedica (CALC) said Wednesday the US Food and Drug Administration completed its review of a protocol amendment and interim safety data from the phase 2 KOURAGE trial of Auxora without comments or questions, and the company said it may continue dosing patients in the study.

The trial is evaluating Auxora in patients with Stage 2 or Stage 3 acute kidney injury with associated acute hypoxemic respiratory failure.

The phase 2 KOURAGE trial of Auxora was paused in January 2026 after an IDMC flagged a mortality imbalance, with CalciMedica saying no drug-related toxicity was found and that baseline disease severity differences were identified.

CalciMedica said it submitted protocol amendments and a safety review of 107 patients, noting that adverse events were consistent with prior experience and not considered drug-related.

The company added it expects FDA feedback on a potential pivotal program in acute pancreatitis in the third quarter of 2026.