Bluejay Diagnostics Announces Completion of Commercial-Scale IL-6 Antibody Production
Rhea-AI Summary
Bluejay Diagnostics (NASDAQ: BJDX) announced completion of commercial-scale production of both polyclonal and monoclonal antibodies targeting interleukin-6 (IL-6) for its Symphony™ cartridge program on December 29, 2025. The company said both antibody types met internal performance criteria for reactivity and intended diagnostic use based on internal testing.
Bluejay reported production using third-party and proprietary immunogens, plans to use its proprietary immunogen for ongoing development and IP strategy, and estimates current inventory can support production of more than nine million Symphony cartridges, with capability to produce additional antibodies as needed. Symphony remains under development and subject to further validation and regulatory review.
Positive
- Commercial-scale production of polyclonal and monoclonal IL-6 antibodies completed
- Inventory supports production of more than 9 million Symphony cartridges
- Established capability to produce additional antibodies as needed
- Use of proprietary immunogen for ongoing development and IP strategy
Negative
- Antibody performance claims are based on internal testing only
- Symphony cartridge remains under development and unvalidated externally
- Timing and success of regulatory review and clearance are uncertain
Key Figures
Market Reality Check
Peers on Argus 1 Down
Sector peers show mixed moves: AEMD up 4.07%, VTAK and TIVC down 7.69% and 12.02%, NUWE down 2.86%, BBLG flat in sector snapshot but later flagged down 6.47% in momentum data. This points to stock-specific factors for BJDX.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 10 | Q3 update & pipeline | Positive | +0.0% | Q3 results plus Symphony clinical and financing progress update. |
| Oct 10 | Private placement close | Negative | -2.7% | Closing of $4.5M private placement with shares and Series F warrants. |
| Oct 09 | Private placement deal | Negative | +75.4% | Announcement of $4.5M at-the-market private placement and warrants. |
| Oct 09 | Strategic partnership | Positive | +75.4% | Expanded SanyoSeiko role for Symphony commercialization and manufacturing support. |
| Aug 07 | Q2 business update | Neutral | -4.8% | Q2 update on SYMON-II trial, manufacturing partners, and capital needs. |
BJDX news often centers on Symphony IL-6 development and financing. Partnership news and the initial private placement announcement coincided with sharp gains, while subsequent financing updates and routine corporate updates saw flat or negative moves, suggesting mixed market tolerance for dilution versus platform progress.
Over the last six months, Bluejay focused on advancing its Symphony IL-6 platform and securing funding. An August Q2 2025 update highlighted the SYMON-II pivotal trial and manufacturing partnerships. October brought a $4.5M private placement and an expanded SanyoSeiko commercialization partnership, both tied to Symphony. The October financing announcement and partnership saw strong price jumps, while the October 10 closing release and November Q3 2025 corporate update produced minimal to negative reactions. Today’s IL-6 antibody production milestone fits this ongoing execution narrative around Symphony readiness.
Regulatory & Risk Context
An effective S-3 shelf filed on 2025-10-23 registers up to 6,930,000 resale shares held by selling stockholders. The company itself is not selling shares in this registration and would only receive cash proceeds if associated warrants are exercised. This structure enables secondary sales while preserving potential warrant-related funding for Bluejay.
Market Pulse Summary
This announcement highlights completion of commercial-scale IL-6 antibody production, providing inventory to support more than nine million Symphony cartridges and advancing Bluejay’s sepsis testing platform. Recent updates emphasize continued SYMON-II trial progress, new partnerships for manufacturing, and reliance on financings such as the $4.5 million private placement. Investors may watch for future data from Symphony validation, regulatory review and clearance milestones, and how the company addresses its stated need for at least $20 million in additional funding through 2027.
Key Terms
monoclonal antibodies medical
biomarker medical
AI-generated analysis. Not financial advice.
ACTON, Mass., Dec. 29, 2025 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay” or the “Company”) announced that it has completed commercial-scale production of both polyclonal and monoclonal antibodies targeting interleukin-6 (IL-6), a biomarker relevant to inflammatory and critical-care applications.
The Company stated that both polyclonal and monoclonal antibodies met internal performance criteria, including reactivity, for use in Symphony™ cartridge manufacturing intended for clinical and potential future commercial applications.
Bluejay has generated polyclonal antibodies using both third-party and internally developed immunogens. The Company intends to utilize antibodies produced from its proprietary immunogen for ongoing development activities in support of its intellectual-property strategy. The monoclonal antibodies produced by the Company, designated for use as detection antibodies in the IL-6 assay, have demonstrated acceptable binding, specificity, and signal performance characteristics for their intended diagnostic use, based on internal testing conducted to date.
Based on current antibody inventory, Bluejay estimates that it has sufficient material to support production of more than nine million Symphony cartridges for clinical and commercial manufacturing purposes. The Company has also established the capability to produce additional antibodies as needed.
The Company noted that Symphony™ remains under development and subject to further validation, regulatory review, and clearance, and that there can be no assurance regarding the timing or success of these activities.
About Bluejay Diagnostics:
Bluejay Diagnostics, Inc. is a medical diagnostics company focused on improving patient outcomes using its Symphony System, a cost-effective, rapid, near-patient testing system for sepsis triage and monitoring of disease progression. Bluejay does not yet have regulatory clearance for the Symphony System, and we will need to receive regulatory authorization from the U.S. Food and Drug Administration before Symphony can be marketed as a diagnostic product in the United States. Bluejay’s first product candidate, an IL-6 Test for sepsis, is designed to provide accurate, reliable results in approximately 20 minutes from ‘sample-to-result’ to help medical professionals make earlier and better triage/treatment decisions. More information is available at www.bluejaydx.com.
Forward-Looking Statements:
This press release contains statements that the Company believes are “forward-looking statements” within the meaning of the Private Litigation Reform Act. Forward-looking statements in this press release include, without limitation, statements pertaining to the status of Bluejay’s commercialization of its Symphony platform. Forward-looking statements may be identified by words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “suggest,” “will,” and similar expressions. The Company has based these forward-looking statements on its current expectations and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements the Company makes. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including market and other conditions and those discussed under item 1A. “Risk Factors” in our Form 10-K for the fiscal year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2025, and in Part II, Item 1A, “Risk Factors” in its Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2025, June 30, 2025 and September 30, 2025, filed with the SEC on May 13, 2025, August 7, 2025 and November 7, 2025, respectively. You should not place undue reliance on these forward-looking statements, as they are subject to risks and uncertainties, and actual results and performance in future periods may not occur or may be materially different from any future results or performance suggested by the forward-looking statements in this release. This press release speaks as of the date indicated above. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. The Company expressly disclaims any obligation to update or revise any forward-looking statements found herein to reflect any future changes in the Company’s expectations of results or any future change in events, except as required by law.
Investor Contact:
Neil Dey
Bluejay Diagnostics, Inc.
neil.dey@bluejaydx.com
978-631-0310
Website: www.bluejaydx.com
FAQ
What did Bluejay Diagnostics (BJDX) announce on December 29, 2025 about IL-6 antibodies?
How many Symphony cartridges can Bluejay (BJDX) support with current antibody inventory?
Will Bluejay (BJDX) use proprietary materials for IL-6 antibody development?
Are Bluejay's (BJDX) IL-6 antibody results externally validated?
Does Bluejay (BJDX) have capacity to produce additional IL-6 antibodies if needed?
What regulatory status did Bluejay (BJDX) give for the Symphony cartridge?
