secwatch.observer — SEC 8-K summary
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Issuer:     CalciMedica, Inc. (CALC)
CIK:        0001534133
Form:       8-K
Filed at:   2026-01-28T23:59:59+00:00
Accession:  0001193125-26-025649
Event type: other_material
Sentiment:  negative
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

CalciMedica discontinues Phase 2 KOURAGE trial of Auxora in AKI after IDMC safety concern
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- IDMC identified a safety concern requiring re-evaluation of study design, particularly enrollment criteria.
- No treatment-related deaths or SAEs requiring expedited FDA reporting in the trial.
- Company plans comprehensive review of unblinded data to inform possible future AKI trials.
- CEO reaffirms optimism for Auxora in acute pancreatitis; pivotal trial design expected H1 2026.
- Also advancing second CRAC inhibitor CM5480 for pulmonary arterial hypertension.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1534133/000119312526025649/0001193125-26-025649-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1534133/000119312526025649/d55769d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-025649

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