Bluejay Diagnostics (NASDAQ: BJDX) advances SYMON II enrollment and manufacturing
Rhea-AI Filing Summary
Bluejay Diagnostics filed a current report describing clinical and operational progress for its Symphony System and IL-6 sepsis test. The company has enrolled 545 patients in its multicenter SYMON™ II IL-6 monitoring study, toward a stated target of 750 patients, which management says exceeds initial expectations and reduces enrollment execution risk. All patients have been enrolled under approved IRB protocols, and management believes the growing, diverse dataset will support future regulatory and partner discussions.
Bluejay also highlights continued advancement of manufacturing readiness across antibodies, tooling, analytical validation, and commercial manufacturing infrastructure, with technology transfer designed to avoid single points of failure. The company reiterates that its Symphony System does not yet have FDA regulatory clearance and cannot be marketed as a diagnostic product in the United States until authorization is obtained.
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Insights
Bluejay advances SYMON II enrollment and manufacturing, lowering execution risk but still pre-revenue and pre-approval.
Bluejay Diagnostics reports enrolling 545 of a targeted 750 patients in its SYMON™ II IL-6 monitoring study. Management characterizes this as exceeding initial expectations and reducing enrollment execution risk, which is often a key uncertainty in multicenter trials.
The update also emphasizes parallel manufacturing readiness workstreams, including antibodies, tooling, analytical validation, and commercial infrastructure, with technology transfer structured to avoid single points of failure. Together, these steps position the company for subsequent data analysis, regulatory engagement, and potential commercialization, though Symphony still lacks FDA clearance and timing and outcomes for any submission are not detailed here.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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Item 7.01 Regulation FD Disclosure.
On February 17, 2026, Bluejay Diagnostics, Inc. issued a press release providing an update regarding its clinical study enrollment and manufacturing readiness initiatives. A copy of that press release is furnished with this report as Exhibit 99.1.
The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be “filed” for the purpose of the Securities Exchange Act of 1934, as amended (“Exchange Act”), nor shall it be incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| 99.1 |
Press release, dated February 17, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
| Bluejay Diagnostics, Inc. | ||
| By: | /s/ Neil Dey | |
| Neil Dey | ||
| President and Chief Executive Officer | ||
Date: February 18, 2026
2
Exhibit 99.1
Bluejay Diagnostics Successfully Enrolls 545 Patients in SYMON™ II Study and Advances Manufacturing Readiness into 2026
ACTON, Mass., February 17, 2026 — Bluejay Diagnostics (NASDAQ: BJDX) today announced that it has successfully enrolled 545 patients in its SYMON™ II multicenter clinical study and has made substantial progress in advancing manufacturing readiness and technology transfer initiatives into 2026, representing a key execution milestone as the Company transitions from clinical enrollment toward data analysis, regulatory engagement, and commercialization readiness.
SYMON-II Clinical trials
Bluejay is successfully enrolling across all participating sites in its SYMON™ II multicenter IL-6 monitoring study, with a total of 545 patients enrolled with a target of 750 patients, exceeding initial expectations. All enrollments are under approved IRB protocols.
Management believes the scale and diversity of the dataset will meaningfully strengthen the Company’s regulatory positioning and support future partner and stakeholder discussions. Current progress materially reduces enrollment execution risk and marks a transition point for the SYMON™ II program.
Manufacturing Readiness
Manufacturing readiness activities continue to advance across multiple parallel workstreams, including antibodies, tooling, analytical validation, and commercial manufacturing infrastructure.
Key developments include:
| ● | Completion of cartridge characterization supporting U.S. commercial production | |
| ● | Completion of monoclonal and polyclonal antibody production, providing supply capacity sufficient for more than 10 million test cartridges | |
| ● | Ongoing fabrication and validation of cartridge and reservoir for FDA submission and commercialization | |
| ● | The Company is also evaluating select material substitutions intended to improve quality consistency and cost efficiency. These efforts are being conducted under defined validation protocols and are actively managed as part of the broader manufacturing readiness plan. |
Management noted that technology transfer activities are progressing without a single point of failure, supported by parallel execution strategies designed to mitigate timing and scale-up risk.
As Bluejay enters 2026, management believes the Company is operating from a materially stronger execution position, with reduced clinical risk and increased focus on value realization through data analysis, regulatory engagement, and commercialization preparedness.
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 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 the Company’s Annual Report on 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 the Company’s 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 clinical progress did Bluejay Diagnostics (BJDX) report in the SYMON II study?
What is the goal of Bluejay Diagnostics’ SYMON II IL-6 monitoring study?
How is Bluejay Diagnostics advancing manufacturing readiness for the Symphony System?
Does Bluejay Diagnostics currently have FDA clearance for the Symphony System?
What does Bluejay Diagnostics say about future regulatory and commercialization plans?
What risk factors does Bluejay Diagnostics reference in connection with this update?
Filing Exhibits & Attachments
5 documents