FDA clears CalciMedica IND for Auxora Phase 2 KOURAGE trial in severe AKI with AHRF

CalciMedica, Inc.

FDA cleared IND for KOURAGE Phase 2 trial of Auxora in stage 2/3 AKI with AHRF; enrollment starts H1 2024, data expected 2025.
Primary endpoint: days alive, ventilator- and dialysis-free through day 30. Secondary: MAKE-90 composite at 90 days.
Phase 2b CARPO trial in acute pancreatitis+SIRS data due H1 2024; Phase 1/2 CRSPA trial in pediatric AIPT data due H2 2024.
Plans to submit IND for oral candidate CM6336 for chronic pancreatitis and rheumatoid arthritis in H2 2024.
Cash runway into H2 2025 after private placement; multiple pipeline readouts ahead.

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