This is a major derisking event for CVKD — FDA alignment on a first-ever pivotal trial design in HIT with positive Phase 2 efficacy data. Expect significant upside momentum. Key catalysts to watch: trial initiation, interim analysis, and any partnership/funding announcements given the $17M market cap and capital requirements for a global Phase 3.
Price Chart
Executive Summary
Cadrenal Therapeutics announced successful completion of its End-of-Phase 2 meeting with the FDA, receiving guidance to advance CAD-1005 into a pivotal Phase 3 trial for heparin-induced thrombocytopenia (HIT). The planned 120-patient, randomized, placebo-controlled study is the first of its kind in HIT and targets an NDA submission in 2029. Phase 2 data showed a >25% absolute reduction in thrombotic events.
Key Facts
- Completed End-of-Phase 2 meeting with FDA for CAD-1005 in HIT
- FDA provided guidance on Phase 3 pivotal trial design, dosing, endpoint, and safety database
- Phase 2 data showed >25% absolute reduction in thrombotic events with CAD-1005 plus standard of care
- Planned Phase 3: randomized, blinded, placebo-controlled, ~120 patients across up to 50 global sites
- Projected NDA submission in 2029
- CAD-1005 has Orphan Drug and Fast Track designations from FDA, orphan status from EMA
- First randomized, blinded, placebo-controlled registration trial ever in HIT
Financial Impact
No financial figures disclosed; $17M market cap micro-cap with no revenue. Phase 3 costs and timeline to NDA (2029) imply significant future capital needs.
Risk Factors
- Execution risk: company must raise sufficient capital to fund a global Phase 3 trial
- Phase 3 may fail to replicate Phase 2 efficacy or meet primary endpoint
- NDA submission not projected until 2029 — long timeline with no near-term revenue
- Micro-cap liquidity risk; stock may be volatile on trial updates
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001213900-26-049754 |
| Document: ea028837601ex99-1.htm | 0001213900-26-049754 |
| Document: 0001213900-26-049754-index-headers.html | 0001213900-26-049754 |
| Document: 0001213900-26-049754-index.html | 0001213900-26-049754 |
| Document: 0001213900-26-049754.txt | 0001213900-26-049754 |
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
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers