secwatch.observer — SEC 8-K summary
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Issuer:     Cadrenal Therapeutics, Inc. (CVKD)
CIK:        0001937993
Form:       8-K
Filed at:   2026-04-30T23:59:59+00:00
Accession:  0001213900-26-049754
Event type: regulatory
Sentiment:  positive
Materiality: 0.78
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Cadrenal completes FDA End-of-Phase 2 meeting; gets guidance for Phase 3 pivotal trial of CAD-1005 in HIT
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- Phase 2 data showed >25% absolute reduction in thrombotic events when CAD-1005 added to standard anticoagulant therapy.
- Planned Phase 3 trial: randomized, blinded, placebo-controlled; ~120 patients at up to 50 sites worldwide.
- Primary endpoint: incidence of new or worsening thrombotic events (centrally adjudicated) in SRA-confirmed HIT patients.
- Projected NDA submission in 2029; first randomized, blinded, placebo-controlled registration trial in HIT.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1937993/000121390026049754/0001213900-26-049754-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1937993/000121390026049754/ea0288376-8k_cadrenal.htm
  HTML page:      https://secwatch.observer/filing/0001213900-26-049754

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