CalciMedica (Nasdaq: CALC) has discontinued the Phase 2 KOURAGE trial of Auxora in Stage 2–3 acute kidney injury (AKI) with associated acute hypoxemic respiratory failure after an Independent Data Monitoring Committee (IDMC) recommended reevaluation for a safety concern related to study design and enrollment criteria.
The company said no deaths were judged related to study drug and no serious adverse events required expedited FDA reporting. CalciMedica will review unblinded data, assess baseline and treatment factors, notify the FDA, complete 90-day follow-up for enrolled patients, and consider modified future AKI trials while progressing other programs including a pivotal acute pancreatitis trial planning in H1 2026 and CM5480 development.
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