secwatch.observer — SEC 8-K summary
======================================

Issuer:     CalciMedica, Inc. (CALC)
CIK:        0001534133
Form:       8-K
Filed at:   2024-10-30T23:59:59+00:00
Accession:  0001193125-24-247004
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

CalciMedica reports positive Phase 2b CARPO data: 100% reduction in severe respiratory failure with high-dose Auxora
--------------------------------------------------------------------------------

- 100% relative risk reduction (p=0.0027) in new-onset severe respiratory failure for combined high/medium dose vs low dose/placebo.
- Stratified win ratio of 1.640 (p=0.0372) for high dose (2.0 mg/kg) Auxora vs placebo across key endpoints.
- No drug-related serious adverse events or deaths at high dose; trend of decreasing TESAE rates with higher dose.
- Planning end-of-Phase 2 meeting with FDA to design Phase 3 trial of Auxora in acute pancreatitis with SIRS.
- Median time to medically indicated discharge reduced by 15 hours for high dose vs placebo (89 vs 104 hours).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1534133/000119312524247004/0001193125-24-247004-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1534133/000119312524247004/d885957d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-247004

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