This enrollment milestone reduces clinical execution risk for Bluejay's lead diagnostic. Traders should monitor for upcoming full enrollment confirmation and potential initiation of regulatory submissions, which could serve as further positive catalysts.
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Executive Summary
Bluejay Diagnostics announced the enrollment of 624 patients in its pivotal SYMON-II clinical trial for its Symphony IL-6 test, with full enrollment of 750 patients expected within 2–3 months. The company noted that inclusion/exclusion criteria have not significantly limited enrollment, supporting trial feasibility.
Key Facts
- 624 patients enrolled in the SYMON-II pivotal trial, targeting 750 total.
- Full enrollment expected within 2–3 months, subject to site activity and patient flow.
- Inclusion and exclusion criteria have not caused significant exclusions, indicating strong trial execution.
- Trial supports 510(k) submission for FDA clearance of the Symphony IL-6 test for sepsis triage.
- Company anticipates progressing to clinical validation and regulatory submission phases.
Financial Impact
No direct financial impact disclosed; advancement de-risks regulatory pathway for lead product candidate.
Risk Factors
- Trial results may not meet efficacy endpoints despite successful enrollment.
- Regulatory clearance of the Symphony IL-6 test is not guaranteed post-trial.
- Company remains pre-revenue with no commercial product yet approved.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001213900-26-040728 |
| Document: ea028534301ex99-1.htm | 0001213900-26-040728 |
| Document: 0001213900-26-040728-index-headers.html | 0001213900-26-040728 |
| Document: 0001213900-26-040728-index.html | 0001213900-26-040728 |
| Document: 0001213900-26-040728.txt | 0001213900-26-040728 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 13, 2026 14d ago | 8-K | $0.8323 | awaiting T+20 | — | $0.5770 (−30.67%) |
Oct 6, 2026 21d ago | 8-K | $0.8107 | awaiting T+20 | — | $0.5770 (−28.83%) |
Aug 13, 2026 10w ago | 8-K | $1.06 | awaiting T+20 | — | $0.5770 (−45.57%) |
Aug 13, 2026 10w ago | Press Release | $1.06 | awaiting T+20 | — | $0.5770 (−45.57%) |
Jul 22, 2026 13w ago | 8-K | $1.14 $0.9393 | ▼ −17.61% | ▼ −20.91% | $0.5770 (−49.39%) |
Jul 13, 2026 15w ago | 3 | $1.22 $0.9872 | ▼ −19.08% | ▼ −22.27% | $0.5770 (−52.70%) |
Jul 10, 2026 15w ago | 3 | $1.45 $1.07 | ▼ −26.21% | ▼ −28.63% | $0.5770 (−60.21%) |
Jun 29, 2026 17w ago | EFFECT | $1.44 $1.03 | ▲ +28.47% | ▲ +28.19% | $0.5770 (+59.93%) |
Jun 17, 2026 18w ago | S-3 | $4.46 $1.30 | ▲ +70.85% | ▲ +71.39% | $0.5770 (+87.06%) |
Jun 9, 2026 20w ago | 8-K | $4.49 $1.40 | ▼ −68.82% | ▼ −72.44% | $0.5770 (−87.15%) |
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