secwatch.observer — SEC 8-K summary
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Issuer:     Cadrenal Therapeutics, Inc. (CVKD)
CIK:        0001937993
Form:       8-K
Filed at:   2026-08-31T12:29:23+00:00
Accession:  0001213900-26-095394
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Cadrenal gets FDA alignment on Phase 3 endpoint for CAD-1005 in HIT
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- FDA Type D meeting July 28, 2026; agreed on primary endpoint definition for worsening HIT through Day 14 or discharge.
- Primary endpoint: proportion of SRA+ participants with adjudicated new or worsening composite thromboembolic events through Day 14 or hospital discharge.
- FDA agreed to placebo control with standard anticoagulation for both CAD-1005 and placebo arms.
- HIT affects ~50,000 patients annually in U.S.; CAD-1005 projected $2B peak annual revenue.
- Phase 3 will assess bleeding as major safety endpoint using ISTH criteria.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1937993/000121390026095394/0001213900-26-095394-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1937993/000121390026095394/ea0303997-8k_cadrenal.htm
  HTML page:      https://secwatch.observer/filing/0001213900-26-095394

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