---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-033981"
form_type: "8-K"
ticker: "CALC"
cik: "0001534133"
company_name: "CalciMedica, Inc."
filed_at: "2024-02-13T23:59:59+00:00"
generated_at: "2026-06-06T03:22:38.865861+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-24-033981
- form_type: 8-K
- ticker: CALC
- cik: 0001534133
- company_name: CalciMedica, Inc.
- filed_at: 2024-02-13T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1534133/000119312524033981/0001193125-24-033981-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1534133/000119312524033981/d777996d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-033981
- JSON: https://secwatch.observer/filing/0001193125-24-033981.json
- Plain text: https://secwatch.observer/filing/0001193125-24-033981.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.