BJDX Bluejay Diagnostics, Inc.
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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.
Actionable Insight
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.
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
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 |
Track record builds as more directional reports settle.
Filters
| Type | Now | ||||
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Jun 9, 2026
today
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8-K
| — | awaiting T+1 | — | — |
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Jun 8, 2026
1d ago
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8-K
| $5.30 awaiting T+1 | awaiting T+1 | — | $4.50 (+15.09%) |
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Jun 6, 2026
4d ago
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Press Release
| $5.26 awaiting T+1 | awaiting T+1 | — | $4.50 (+14.45%) |
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Jun 2, 2026
7d ago
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Press Release
| $4.34 $4.51 | ▼ −3.92% | ▼ −4.61% | $4.50 (−3.69%) |
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Jun 2, 2026
7d ago
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PRESS-RELEASE / 8-K
| $4.34 $4.51 | ▲ +3.92% | ▲ +4.61% | $4.50 (+3.69%) |
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May 18, 2026
22d ago
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Insider Cluster
| $1.71 $1.78 | ▲ +3.98% | ▲ +2.94% | $4.50 (+163.16%) |
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May 7, 2026
4w ago
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8-K
| $1.72 $1.76 | ▲ +2.33% | ▲ +2.09% | $4.50 (+161.63%) |
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May 7, 2026
4w ago
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Press Release
| $1.72 $1.76 | ▲ +2.33% | ▲ +2.09% | $4.50 (+161.63%) |
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Apr 7, 2026
9w ago
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8-K
| $2.05 $2.05 | · 0.00% | ▼ −2.54% | $4.50 (+119.51%) |
US Market Status
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