Auxora - (KOURAGE)

June 24, 2026: CalciMedica, Inc. (NASDAQ: CALC) said the FDA reviewed a protocol amendment and interim safety data for the Phase 2 KOURAGE trial evaluating Auxora (zegocractin) in patients with Stage 2–3 acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF). After more than 60 days, the company received no FDA comments or questions and no clinical hold communication, allowing dosing to continue.

The company had paused KOURAGE enrollment in January 2026 following an Independent Data Monitoring Committee recommendation related to a mortality imbalance requiring study design reevaluation; the IDMC found no evidence of drug-related toxicity. In March 2026, CalciMedica submitted an amendment refining inclusion criteria and stratification methodology and provided a comprehensive safety assessment from 107 dosed patients (including cause-of-death information and SAE analyses). CalciMedica stated SAEs appeared consistent with prior Auxora experience and not drug-related; FDA’s Clinical Pharmacology team in the Division of Cardiology and Nephrology had no comments.

Upcoming: CalciMedica expects FDA feedback in Q3 2026 on the design of a potential pivotal Auxora program in acute pancreatitis. The company also noted plans for a Phase 1b proof-of-concept study of Auxora in pulmonary arterial hypertension and expects IND clearance for oral CRAC inhibitor CM5480 in mid-2027.