Monitor for data readout and FDA submission timeline over the coming months. The 17% mortality rate and large dataset are positive for the 510(k) case, but regulatory and commercialization risks remain high for this pre-revenue micro-cap.
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Executive Summary
Bluejay Diagnostics completed enrollment of 750 patients in its pivotal SYMON-II clinical study for the Symphony IL-6 sepsis test, ahead of schedule. Preliminary data shows a 17% 28-day mortality rate, providing a robust dataset for planned FDA 510(k) submission. This operational milestone reduces clinical risk but does not guarantee regulatory clearance.
Key Facts
- SYMON-II enrolled 750 patients ahead of schedule in a multicenter study evaluating Symphony IL-6 for early assessment of 28-day sepsis mortality risk.
- Preliminary observations indicate an approximately 17% 28-day mortality rate in the enrolled population.
- Results are expected to support a 510(k) application to the FDA for the Symphony IL-6 platform.
- The Symphony platform is an investigational device and has not received FDA clearance.
Financial Impact
No financial data provided; the filing is a clinical milestone update with no revenue, earnings, or guidance.
Risk Factors
- FDA clearance is not guaranteed; the Symphony platform remains investigational.
- Competition from other sepsis diagnostics and biomarker tests.
- Cash burn risk given no approved product and $1M market cap.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001213900-26-080474 |
| Document: ea029895501ex99-1.htm | 0001213900-26-080474 |
| Document: 0001213900-26-080474-index-headers.html | 0001213900-26-080474 |
| Document: 0001213900-26-080474-index.html | 0001213900-26-080474 |
| Document: 0001213900-26-080474.txt | 0001213900-26-080474 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 13, 2026 13d ago | 8-K | $0.8323 | awaiting T+20 | — | $0.5850 (−29.71%) |
Oct 6, 2026 20d ago | 8-K | $0.8107 | awaiting T+20 | — | $0.5850 (−27.84%) |
Aug 13, 2026 10w ago | 8-K | $1.06 | awaiting T+20 | — | $0.5850 (−44.81%) |
Aug 13, 2026 10w ago | Press Release | $1.06 | awaiting T+20 | — | $0.5850 (−44.81%) |
Jul 22, 2026 13w ago | 8-K | $1.14 $0.9393 | ▼ −17.61% | ▼ −20.91% | $0.5850 (−48.68%) |
Jul 13, 2026 15w ago | 3 | $1.22 $0.9872 | ▼ −19.08% | ▼ −22.27% | $0.5850 (−52.05%) |
Jul 10, 2026 15w ago | 3 | $1.45 $1.07 | ▼ −26.21% | ▼ −28.63% | $0.5850 (−59.66%) |
Jun 29, 2026 17w ago | EFFECT | $1.44 $1.03 | ▲ +28.47% | ▲ +28.19% | $0.5850 (+59.38%) |
Jun 17, 2026 18w ago | S-3 | $4.46 $1.30 | ▲ +70.85% | ▲ +71.39% | $0.5850 (+86.88%) |
Jun 9, 2026 19w ago | 8-K | $4.49 $1.40 | ▼ −68.82% | ▼ −72.44% | $0.5850 (−86.97%) |
US Market Status
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