This is a routine operational milestone with no financial data or regulatory clearance. Monitor for FDA 510(k) submission updates and SYMON-II pivotal study results for the next catalyst.
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Executive Summary
Bluejay Diagnostics announced it has completed the establishment of a manufacturing site for Symphony cartridges, achieving a contractual milestone under its amended license agreement with Toray Industries ahead of the October 23, 2026 deadline. The milestone is a procedural step toward regulatory submission and potential commercialization, but the Symphony IL-6 Test remains unapproved by the FDA and not available for commercial use.
Key Facts
- Manufacturing site established for Symphony cartridges ahead of October 23, 2026 contractual deadline with Toray Industries
- Manufacturing strategy involves SanyoSeiko Co., Ltd. in Japan and ALURIS Sciences in the United States
- Symphony IL-6 Test has not been cleared or approved by the FDA and is not available for commercial clinical use
- SYMON clinical study program includes SYMON-I, SYMON-II (pivotal), and SYMON-III pilot studies
Financial Impact
No financial figures disclosed in the filing
Risk Factors
- Symphony IL-6 Test has not received FDA clearance and may never be approved
- No revenue or commercialization timeline provided; company remains pre-commercial
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001213900-26-108779 |
| Document: ea030840101ex99-1.htm | 0001213900-26-108779 |
| Document: 0001213900-26-108779-index-headers.html | 0001213900-26-108779 |
| Document: 0001213900-26-108779-index.html | 0001213900-26-108779 |
| Document: 0001213900-26-108779.txt | 0001213900-26-108779 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 13, 2026 13d ago | 8-K | $0.8323 | awaiting T+20 | — | $0.5600 (−32.72%) |
Oct 6, 2026 20d ago | 8-K | $0.8107 | awaiting T+20 | — | $0.5600 (−30.92%) |
Aug 13, 2026 10w ago | 8-K | $1.06 | awaiting T+20 | — | $0.5600 (−47.17%) |
Aug 13, 2026 10w ago | Press Release | $1.06 | awaiting T+20 | — | $0.5600 (−47.17%) |
Jul 22, 2026 13w ago | 8-K | $1.14 $0.9393 | ▼ −17.61% | ▼ −20.91% | $0.5600 (−50.88%) |
Jul 13, 2026 15w ago | 3 | $1.22 $0.9872 | ▼ −19.08% | ▼ −22.27% | $0.5600 (−54.10%) |
Jul 10, 2026 15w ago | 3 | $1.45 $1.07 | ▼ −26.21% | ▼ −28.63% | $0.5600 (−61.38%) |
Jun 29, 2026 17w ago | EFFECT | $1.44 $1.03 | ▲ +28.47% | ▲ +28.19% | $0.5600 (+61.11%) |
Jun 17, 2026 18w ago | S-3 | $4.46 $1.30 | ▲ +70.85% | ▲ +71.39% | $0.5600 (+87.44%) |
Jun 9, 2026 19w ago | 8-K | $4.49 $1.40 | ▼ −68.82% | ▼ −72.44% | $0.5600 (−87.53%) |
US Market Status
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