CalciMedica Cleared to Resume KOURAGE Trial After FDA Review

The La Jolla-based biopharmaceutical firm voluntarily paused enrollment in the Phase 2 trial this past January. The decision followed an Independent Data Monitoring Committee recommendation linked to a mortality imbalance among study participants. While the committee found no evidence that the drug caused toxicity, a internal investigation—conducted alongside external experts—revealed that imbalances in baseline disease severity necessitated a redesign of the study's inclusion criteria and stratification methods.

CalciMedica submitted these protocol refinements in March, accompanied by a comprehensive safety analysis of the 107 patients treated before the pause. The company maintains that the observed serious adverse events were consistent with the drug's known profile and were not drug-related. Because the trial was never under a formal clinical hold, the lack of FDA feedback allows the company to proceed with its development plans for Auxora. Looking ahead, CalciMedica expects to receive regulatory feedback in the third quarter of 2026 regarding a potential pivotal program for the drug in treating acute pancreatitis.