---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-24-031371"
form_type: "8-K"
ticker: "CVKD"
cik: "0001937993"
company_name: "Cadrenal Therapeutics, Inc."
filed_at: "2024-04-09T23:59:59+00:00"
generated_at: "2026-06-04T01:10:05.114469+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Cadrenal Therapeutics receives FDA Orphan Drug Designation for tecarfarin in VAD patients

## Summary
- FDA granted ODD for tecarfarin to prevent thromboembolism/thrombosis in patients with LVADs, RVADs, biventricular assist devices, and total artificial hearts.
- ODD provides up to 7 years of U.S. market exclusivity after approval, tax credits for clinical research, and NDA user fee waiver.
- This is tecarfarin's second ODD; first was for prevention of systemic thromboembolism in ESKD/AFib patients.
- Warfarin achieves target anticoagulation only 56% of the time in VAD patients; DOACs like Eliquis are not indicated for VADs.
- Cadrenal CEO states company is dedicated to advancing tecarfarin through clinical development options as swiftly as possible.

## SEC filing metadata
- accession: 0001213900-24-031371
- form_type: 8-K
- ticker: CVKD
- cik: 0001937993
- company_name: Cadrenal Therapeutics, Inc.
- filed_at: 2024-04-09T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1937993/000121390024031371/0001213900-24-031371-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1937993/000121390024031371/ea0203558-8k_cadrenal.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-24-031371
- JSON: https://secwatch.observer/filing/0001213900-24-031371.json
- Plain text: https://secwatch.observer/filing/0001213900-24-031371.txt

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