secwatch.observer — SEC 8-K summary
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Issuer:     CalciMedica, Inc. (CALC)
CIK:        0001534133
Form:       8-K
Filed at:   2024-06-27T23:59:59+00:00
Accession:  0001193125-24-169805
Event type: other_material
Sentiment:  positive
Materiality: 0.95
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

CalciMedica announces positive Phase 2b CARPO topline data for Auxora in acute pancreatitis
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- Trial enrolled 216 patients; primary endpoint met with up to 43.6% relative risk reduction in time to solid food tolerance vs placebo in hyper-inflamed subgroup.
- Auxora showed statistically significant dose response: severe organ failure reduced by up to 61.7% in medium dose vs placebo.
- High dose patients had 0% hospital stays >21 days vs 5.7% placebo; combined high/medium dose showed 84.3% relative risk reduction.
- Auxora well-tolerated: only 1 drug-related treatment-emergent serious adverse event across all dose groups; no related deaths in high dose.
- Company plans End-of-Phase 2 meeting with FDA and intends to present additional CT data at a medical meeting later in 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1534133/000119312524169805/0001193125-24-169805-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1534133/000119312524169805/d124614d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-169805

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