The FDA alignment removes a key regulatory uncertainty for CAD-1005's Phase 3 design. Traders should watch for trial initiation announcements and enrollment updates as the next catalysts. Given the micro-cap status ($5M market cap), any positive data readout could drive significant upside, but financing risk remains high.
Price Chart
Executive Summary
Cadrenal Therapeutics announced positive feedback from an FDA Type D meeting for its Phase 3 registrational study of CAD-1005 in heparin-induced thrombocytopenia (HIT). The FDA aligned on the primary endpoint definition, statistical analysis plan, and use of placebo control, de-risking the regulatory path forward for this first-in-class 12-LOX inhibitor targeting a $2B peak revenue opportunity.
Key Facts
- FDA Type D meeting held July 28, 2026 resulted in alignment on Phase 3 protocol and Statistical Analysis Plan for CAD-1005
- FDA agreed on optimized 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 in both arms
- CAD-1005 has Orphan Drug Designation and Fast Track status from FDA for HIT
- Approximately 50,000 confirmed acute HIT diagnoses annually in the U.S.; company estimates $2 billion peak annual revenue opportunity
- Phase 3 trial will also assess bleeding as a major safety endpoint using ISTH criteria
Financial Impact
Regulatory de-risking of CAD-1005 Phase 3 program; peak revenue opportunity estimated at $2 billion annually if approved
Risk Factors
- Phase 3 trial failure or negative data could wipe out value
- Micro-cap with no revenue requires additional financing to complete the trial
- Competing therapies for HIT may limit commercial uptake
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001213900-26-095394 |
| Document: ea030399701ex99-1.htm | 0001213900-26-095394 |
| Document: 0001213900-26-095394-index-headers.html | 0001213900-26-095394 |
| Document: 0001213900-26-095394-index.html | 0001213900-26-095394 |
| Document: 0001213900-26-095394.txt | 0001213900-26-095394 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 7, 2026 19d ago | 8-K | $0.9723 | awaiting T+60 | — | $0.9298 (−4.37%) |
Aug 31, 2026 8w ago | 8-K | $1.75 | awaiting T+60 | — | $0.9298 (−46.87%) |
Jul 21, 2026 13w ago | 8-K | $2.17 $0.9970 | ▼ −54.06% | ▼ −58.03% | $0.9298 (−57.15%) |
Jul 21, 2026 13w ago | EFFECT | $2.17 $0.9970 | ▼ −54.06% | ▼ −58.03% | $0.9298 (−57.15%) |
Jul 1, 2026 16w ago | Press Release | $3.60 $1.12 | ▲ +68.89% | ▲ +71.94% | $0.9298 (+74.17%) |
Jun 29, 2026 16w ago | 8-K | $3.34 $1.32 | ▼ −60.48% | ▼ −64.04% | $0.9298 (−72.16%) |
Jun 18, 2026 18w ago | 8-K | $3.50 $1.06 | ▼ −69.71% | ▼ −71.61% | $0.9298 (−73.43%) |
Jun 15, 2026 18w ago | 144 | $3.04 $1.18 | ▲ +61.18% | ▲ +62.18% | $0.9298 (+69.41%) |
May 7, 2026 24w ago | Press Release | $6.02 $1.96 | ▼ −67.44% | ▼ −71.27% | $0.9298 (−84.55%) |
Apr 30, 2026 25w ago | 8-K | $6.67 $2.06 | ▼ −69.12% | ▼ −72.22% | $0.9298 (−86.06%) |
US Market Status
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