- Trial Phase
- Phase 3-ready (per company disclosure); no active Phase 2/3 ClinicalTrials.gov record for tecarfarin found in ingested d
- Time to Market
- Unknown, likely several years if at all: the company calls tecarfarin "Phase 3-ready," but no pivotal-trial start or NDA timeline was identified, and a Kawasaki-disease approval would require a partner-funded registrational program plus FDA review. No revenue exists to self-fund it.
- Why 3/10
- No hard, dated binary for tecarfarin in the next ~12 months: the FDA Rare Pediatric Disease Designation (RPDD) filing was announced but not yet granted, no pivotal-trial readout or PDUFA is scheduled in available data, and tecarfarin is one of three assets at a ~$6M pre-revenue company where CAD-1005 is the stated near-term priority — so per the rubric (mid-stage drug with no dated catalyst; partnership/designation news not counted), the score caps at 3.
Watch for (1) FDA action on the tecarfarin RPDD request for Kawasaki disease and (2) any definitive out-licensing/co-development agreement (an Item 1.01 8-K) from the partnering process Cadrenal opened on July 21, 2026 — either could re-rate this ~$6M micro-cap. Absent those, tecarfarin alone carries no near-term catalyst, and the share price (~$1.65 vs a $14.64 52-week high) already reflects a crashed valuation with dilution overhang from the July placement and effective S-3 shelf.
Price Chart
Executive Summary
Tecarfarin is Cadrenal Therapeutics' (Nasdaq: CVKD) late-stage oral cardiovascular asset, currently framed as the "orphan regulatory acceleration" pillar of a ~$6M market-cap, pre-revenue pipeline being shopped to partners. In June 2026 the company announced it would file for FDA Rare Pediatric Disease Designation for tecarfarin in Kawasaki disease — which, if granted and followed by approval, would make it eligible for a Priority Review Voucher reportedly worth $180M–$205M, multiples of the company's entire market cap. However, there is no dated regulatory binary in the next 12 months, no revenue, roughly $4M cash at 2025 year-end, a recent ~33%-dilutive private placement, an effective S-3 shelf, and CEO insider selling — so the drug is genuine optionality at a heavily distressed micro-cap, not a near-term catalyst.
How It Works
An investigational oral cardiovascular drug candidate that Cadrenal positions in its "Cardiac Acute Critical Care Franchise" and is developing for Kawasaki disease — a rare childhood illness that inflames the heart's blood vessels and is a leading cause of acquired heart disease in children. As an "orphan regulatory acceleration" asset, it targets a small pediatric population where FDA rare-disease incentives (RPDD / Priority Review Voucher) apply.
Trial Status
No registered pivotal trial located in available data. Cadrenal describes tecarfarin as Phase 3-ready in its "Orphan Regulatory Acceleration" pillar (July 21, 2026 8-K), announced plans to file an FDA Rare Pediatric Disease Designation request for Kawasaki disease (June 18, 2026), and has put the asset into a formal out-license/monetize/co-develop partnering process — with no binding deal or financial terms disclosed as of the latest filings.
The Two-Sided Case
Upcoming Catalysts
- FDA action on the tecarfarin RPDD request for Kawasaki disease (filing announced June 18, 2026; decision timing not disclosed)
- Any definitive tecarfarin out-licensing / co-development agreement from the formal partnering process opened July 21, 2026 (would surface as an Item 1.01 8-K)
- Q2 2026 earnings (scheduled ~Aug 10, 2026 per event ledger) and any capital raise under the now-effective S-3 shelf
- BIO 2026 partner meetings (company said it would present the pipeline to global pharma partners)
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Cadrenal Therapeutics, Inc. 8-K CVKD ·Originating report