Watch for completion of SYMON-II IL-6 performance analyses and any subsequent 510(k) submission — the binary regulatory catalyst remains the key value driver for this pre-revenue stock.
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Executive Summary
Bluejay Diagnostics announced baseline clinical characteristics from its SYMON-II pivotal study for the Symphony IL-6 Test in sepsis. The dataset includes 777 evaluable patients with an 18% 28-day mortality rate, supporting a planned 510(k) submission to the FDA. No financial data, guidance, or regulatory outcomes were disclosed — this is a clinical milestone update only.
Key Facts
- SYMON-II analysis includes 777 evaluable patients: 637 survivors and 140 non-survivors (18% mortality rate).
- 39.5% of patients met Sepsis-3 criteria for septic shock; 84.0% had bacterial infection.
- Septic shock present in 56.4% of non-survivors vs 35.8% of survivors.
- Baseline characteristics do not establish prognostic performance, sensitivity, specificity, or regulatory acceptability.
- Symphony IL-6 Test has not been FDA cleared or approved and is not commercially available.
Financial Impact
No financial figures reported; pre-revenue clinical-stage diagnostics company.
Risk Factors
- SYMON-II results may fail to demonstrate adequate sensitivity/specificity for FDA clearance.
- No commercial revenue; cash burn risk without near-term regulatory approval.
- Competing sepsis diagnostic platforms may reach market first.
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001213900-26-106999 |
| Document: ea030776901ex99-1.htm | 0001213900-26-106999 |
| Document: 0001213900-26-106999-index-headers.html | 0001213900-26-106999 |
| Document: 0001213900-26-106999-index.html | 0001213900-26-106999 |
| Document: 0001213900-26-106999.txt | 0001213900-26-106999 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 13, 2026 13d ago | 8-K | $0.8323 | awaiting T+20 | — | $0.5601 (−32.70%) |
Oct 6, 2026 20d ago | 8-K | $0.8107 | awaiting T+20 | — | $0.5601 (−30.91%) |
Aug 13, 2026 10w ago | 8-K | $1.06 | awaiting T+20 | — | $0.5601 (−47.16%) |
Aug 13, 2026 10w ago | Press Release | $1.06 | awaiting T+20 | — | $0.5601 (−47.16%) |
Jul 22, 2026 13w ago | 8-K | $1.14 $0.9393 | ▼ −17.61% | ▼ −20.91% | $0.5601 (−50.87%) |
Jul 13, 2026 15w ago | 3 | $1.22 $0.9872 | ▼ −19.08% | ▼ −22.27% | $0.5601 (−54.09%) |
Jul 10, 2026 15w ago | 3 | $1.45 $1.07 | ▼ −26.21% | ▼ −28.63% | $0.5601 (−61.37%) |
Jun 29, 2026 17w ago | EFFECT | $1.44 $1.03 | ▲ +28.47% | ▲ +28.19% | $0.5601 (+61.10%) |
Jun 17, 2026 18w ago | S-3 | $4.46 $1.30 | ▲ +70.85% | ▲ +71.39% | $0.5601 (+87.44%) |
Jun 9, 2026 19w ago | 8-K | $4.49 $1.40 | ▼ −68.82% | ▼ −72.44% | $0.5601 (−87.53%) |
US Market Status
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