secwatch.observer — SEC 8-K summary
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Issuer:     CalciMedica, Inc. (CALC)
CIK:        0001534133
Form:       8-K
Filed at:   2024-02-13T23:59:59+00:00
Accession:  0001193125-24-033981
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1534133/000119312524033981/0001193125-24-033981-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1534133/000119312524033981/d777996d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-033981

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer