Monitor FDA response to the RPDD submission and any partnership announcements from the BIO International Convention (June 22–25). The PRV potential provides a non-dilutive capital pathway, but the filing is a preliminary regulatory step with no near-term revenue catalyst.
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Executive Summary
Cadrenal Therapeutics announced plans to file a Rare Pediatric Disease Designation (RPDD) request with the FDA for tecarfarin in Kawasaki disease, a leading cause of acquired heart disease in children. If granted and tecarfarin is approved, the company would be eligible for a Priority Review Voucher valued at $180M–$205M. The filing also outlines a dual-track portfolio strategy (CAD-1005 global pharma track and tecarfarin rare disease track) to be presented at the BIO International Convention. No financial results or material agreements were disclosed.
Key Facts
- Plans to submit Rare Pediatric Disease Designation (RPDD) request to FDA for tecarfarin in Kawasaki disease with coronary artery aneurysms
- Priority Review Voucher (PRV) eligibility if RPDD granted and tecarfarin approved; recent PRV sales $180M–$205M
- Dual-track portfolio strategy: CAD-1005 (Phase 3-ready 12-LOX inhibitor) and tecarfarin for Kawasaki disease
- Company presenting at BIO International Convention June 22–25, 2026 in San Diego
- Kawasaki disease is the leading cause of acquired heart disease in children in developed nations; up to 25% of untreated children develop coronary artery aneurysms
Financial Impact
No financial results reported. Potential PRV value of $180M–$205M contingent on FDA designation and subsequent approval.
Risk Factors
- FDA may not grant Rare Pediatric Disease Designation
- Tecarfarin may not receive approval for Kawasaki disease even if RPDD granted
- Company may require additional capital to advance pipeline; no current revenue disclosed
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001213900-26-069902 |
| Document: ea029523401ex99-1.htm | 0001213900-26-069902 |
| Document: 0001213900-26-069902-index-headers.html | 0001213900-26-069902 |
| Document: 0001213900-26-069902-index.html | 0001213900-26-069902 |
| Document: 0001213900-26-069902.txt | 0001213900-26-069902 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 7, 2026 19d ago | 8-K | $0.9723 | awaiting T+60 | — | $0.9100 (−6.41%) |
Aug 31, 2026 8w ago | 8-K | $1.75 | awaiting T+60 | — | $0.9100 (−48.00%) |
Jul 21, 2026 13w ago | 8-K | $2.17 $0.9970 | ▼ −54.06% | ▼ −58.03% | $0.9100 (−58.06%) |
Jul 21, 2026 13w ago | EFFECT | $2.17 $0.9970 | ▼ −54.06% | ▼ −58.03% | $0.9100 (−58.06%) |
Jul 1, 2026 16w ago | Press Release | $3.60 $1.12 | ▲ +68.89% | ▲ +71.94% | $0.9100 (+74.72%) |
Jun 29, 2026 16w ago | 8-K | $3.34 $1.32 | ▼ −60.48% | ▼ −64.04% | $0.9100 (−72.75%) |
Jun 18, 2026 18w ago | 8-K | $3.50 $1.06 | ▼ −69.71% | ▼ −71.61% | $0.9100 (−74.00%) |
Jun 15, 2026 18w ago | 144 | $3.04 $1.18 | ▲ +61.18% | ▲ +62.18% | $0.9100 (+70.07%) |
May 7, 2026 24w ago | Press Release | $6.02 $1.96 | ▼ −67.44% | ▼ −71.27% | $0.9100 (−84.88%) |
Apr 30, 2026 25w ago | 8-K | $6.67 $2.06 | ▼ −69.12% | ▼ −72.22% | $0.9100 (−86.36%) |
US Market Status
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