---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-26-095394"
form_type: "8-K"
ticker: "CVKD"
cik: "0001937993"
company_name: "Cadrenal Therapeutics, Inc."
filed_at: "2026-08-31T12:29:23+00:00"
generated_at: "2026-08-31T12:30:40.792968+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Cadrenal gets FDA alignment on Phase 3 endpoint for CAD-1005 in HIT

## Summary
- 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.

## SEC filing metadata
- accession: 0001213900-26-095394
- form_type: 8-K
- ticker: CVKD
- cik: 0001937993
- company_name: Cadrenal Therapeutics, Inc.
- filed_at: 2026-08-31T12:29:23+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1937993/000121390026095394/0001213900-26-095394-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1937993/000121390026095394/ea0303997-8k_cadrenal.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-26-095394
- JSON: https://secwatch.observer/filing/0001213900-26-095394.json
- Plain text: https://secwatch.observer/filing/0001213900-26-095394.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.