secwatch.observer — SEC 8-K summary
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Issuer:     WINDTREE THERAPEUTICS INC /DE/ (WINT)
CIK:        0000946486
Form:       8-K
Filed at:   2024-09-30T23:59:59+00:00
Accession:  0001437749-24-030219
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Windtree announces positive Phase 2b topline results for istaroxime in early cardiogenic shock
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- Primary endpoint met: istaroxime significantly improved systolic blood pressure (SBP AUC) vs placebo (p=0.0070) in combined Part A/B analysis.
- Istaroxime improved cardiac output by ~15%, reduced heart rate, and lowered pulmonary capillary wedge pressure (PCWP) vs placebo at multiple timepoints.
- Renal function (eGFR) improved with istaroxime at 48 hours (p=0.0291); NYHA heart failure classification improved through 72 hours.
- Serious adverse events were similar: 10.5% istaroxime vs 27.3% placebo; no increase in clinically significant arrythmias observed.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/946486/000143774924030219/0001437749-24-030219-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/946486/000143774924030219/wint20240929_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-030219

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