Bluejay Diagnostics, Inc. Announces Completion of 624 Patient Enrollments in SYMON-II Pivotal Clinical Trial

Bluejay Diagnostics (NASDAQ: BJDX) announced enrollment of 624 patients in the pivotal SYMON-II trial testing the Symphony™ IL-6 platform for sepsis triage and monitoring.

Rhea-AI Summary

Bluejay Diagnostics (NASDAQ: BJDX) announced enrollment of 624 patients in the pivotal SYMON-II trial testing the Symphony™ IL-6 platform for sepsis triage and monitoring.

The study target is 750 patients; the company expects to complete enrollment within 2–3 months, contingent on site activity and patient flow, and noted inclusion/exclusion criteria have not materially limited enrollment.

Positive

• 624 patients enrolled in SYMON-II pivotal trial
• Study enrollment progressing toward 750-patient target
• Company reports inclusion/exclusion criteria not materially excluding patients

Negative

• Trial not yet complete; target enrollment 750 remains unmet
• Estimated completion 2–3 months depends on site activity and patient flow

Argus Apr 7 session

-0.49% close to close Open Argus

Details

News Market Reaction – BJDX

In the Apr 7 session, BJDX declined 0.49%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights meaningful advancement of the SYMON‑II pivotal trial, with 624 of a pla...

Analysis

This announcement highlights meaningful advancement of the SYMON‑II pivotal trial, with 624 of a planned 750 patients enrolled and completion expected within 2–3 months, subject to site activity. It builds on prior disclosures emphasizing Symphony IL‑6 as the core asset and the path toward clinical validation and regulatory submission. At the same time, recent filings underscore going‑concern uncertainty, heavy historical dilution, and reliance on future capital raises, all key factors to monitor alongside upcoming trial and regulatory milestones.

Key Figures

Patients enrolled: 624 patients Target enrollment: 750 patients Enrollment timeline: 2 to 3 months

Patients enrolled

624 patients

SYMON-II pivotal clinical trial enrollment at announcement

Target enrollment

750 patients

Planned SYMON-II pivotal trial size

Enrollment timeline

2 to 3 months

Company expectation to complete SYMON-II enrollment, subject to site activity

Historical Context

5 past events · Latest: Mar 12

5 events

1. Mar 12

   Scientific conference visibility

   24h Move

   -2.5%

   SYMON-I pilot abstract accepted for SAEM, highlighting IL-6 and ongoing SYMON-II.

2. Mar 06

   Corporate strategy update

   24h Move

   -2.1%

   Outlined 2026 priorities, cash of $5.2M, equity, losses and funding needs.

3. Feb 20

   Warrant exercise update

   24h Move

   +1.5%

   All prefunded warrants exercised, leaving ~972,000 shares and 1.5M cash warrants.

4. Feb 17

   Clinical & manufacturing progress

   24h Move

   +0.8%

   SYMON II enrollment to 545 of 750 and key manufacturing readiness milestones.

5. Jan 27

   Reverse stock split

   24h Move

   -3.9%

   1-for-4 reverse split reducing outstanding shares and adjusting warrants and awards.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

pivotal clinical study, interleukin-6, il-6, sepsis, +4 more

8 terms

pivotal clinical study medical

"SYMON-II Trial, a pivotal clinical study evaluating the Company’s Symphony..."

A pivotal clinical study is the key, late-stage medical trial designed to show whether a drug or medical device works and is safe enough for regulators to approve it. Think of it as the final exam for a treatment: a strong pass typically clears the path to market access, while a failure can stop approval and materially affect expected sales, company value, and investor returns.

interleukin-6 medical

"evaluating the Company’s Symphony™ platform for interleukin-6 (IL-6) testing..."

Interleukin-6 is a small signaling protein the body releases to coordinate inflammation and immune responses, acting like a fire alarm that summons immune cells to sites of infection or tissue damage. It matters to investors because high or persistent levels are linked to disease activity and are a common drug target or clinical trial biomarker; changes in IL-6-related data can influence a therapy's approval prospects, market potential, and a company's valuation.

il-6 medical

"Symphony™ platform for interleukin-6 (IL-6) testing in critical care settings..."

Interleukin-6 (IL-6) is a small signaling protein the body releases as an alarm during infection, injury, or chronic inflammation; think of it as a smoke detector that calls immune cells to action. It matters to investors because IL-6 levels can serve as a biomarker for disease severity and a target for therapies—drugs that block or modulate IL-6 can change treatment outcomes, regulatory decisions, and commercial prospects in healthcare markets.

sepsis medical

"testing in critical care settings to determine patient acuity for sepsis triage..."

Sepsis is a dangerous medical condition in which an infection triggers the body's defenses to damage its own tissues and organs, often leading to organ failure and emergency hospital care. For investors it matters because sepsis drives demand for diagnostics, antibiotics, intensive-care treatments and hospital resources, affects healthcare costs and insurer payouts, and can influence the commercial prospects and valuation of companies developing related tests, drugs and devices.

triage medical

"determine patient acuity for sepsis triage and monitoring."

Triage is the process of sorting or prioritizing items based on their importance or urgency. In finance, it often involves evaluating investments, tasks, or issues to decide which ones need immediate attention and which can wait, helping individuals or organizations focus on what matters most. This approach ensures resources are used efficiently and critical matters are addressed promptly.

regulatory submission regulatory

"progressing toward the next phases of clinical validation and regulatory submission activities..."

A regulatory submission is the package of documents, data and forms a company sends to a government agency to request approval for a product, drug, device, or a change in how it is marketed or made. Think of it like applying for a building permit: the agency reviews safety, effectiveness and compliance before giving the green light; for investors, the timing, completeness and outcome of a submission can change a company’s revenue prospects, costs and risk profile.

critical care medical

"testing in critical care settings to determine patient acuity..."

Critical care involves the specialized medical treatment provided to patients with life-threatening conditions that require constant monitoring and immediate intervention. It is essential for saving lives during severe health emergencies. For investors, understanding critical care highlights the importance and stability of healthcare services that support urgent and complex medical needs.

near-patient testing medical

"a medical diagnostics company focused on rapid, near-patient testing..."

Near-patient testing means medical tests performed close to where a patient is being seen — for example in a clinic, pharmacy, ambulance, or at home — instead of being sent to a distant laboratory. For investors, it matters because these faster, simpler tests can speed diagnosis and treatment, broaden access, lower ongoing costs, and create new sales and recurring-revenue opportunities much like a compact kitchen appliance that brings restaurant capabilities into the home.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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ACTON, Mass., April 07, 2026 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (“Bluejay” or the “Company”), a medical diagnostics company focused on rapid, near-patient testing, today announced the successful enrollment of 624 patients in its ongoing SYMON-II Trial, a pivotal clinical study evaluating the Company’s Symphony™ platform for interleukin-6 (IL-6) testing in critical care settings to determine patient acuity for sepsis triage and monitoring.

The SYMON-II study has a target enrollment of 750 patients, and the Company expects to complete enrollment within the next 2 to 3 months, subject to site activity and patient flow.

Importantly, the study’s inclusion and exclusion criteria have not caused a significant number of patients to be excluded from enrollment.

“This milestone reflects the strong execution by our clinical team and the continued commitment of our investigators and clinical partners,” said Neil Dey, CEO of Bluejay Diagnostics. “Reaching 624 enrolled patients positions us well to complete enrollment in the near term, bringing us closer to delivering meaningful clinical insights that could improve outcomes in critical care. We are particularly encouraged by the fact that study’s inclusion and exclusion criteria have not caused a significant number of patients to be excluded from enrollment.”

The SYMON-II trial is designed to support the clinical validation of Bluejay’s Symphony™ IL-6 test, which aims to provide rapid, near-patient results to aid clinicians in assessing patient severity and guiding timely decision-making in acute care environments.

With enrollment nearing completion, Bluejay anticipates progressing toward the next phases of clinical validation and regulatory submission activities, consistent with its broader strategy to advance near-patient testing and real-time monitoring in critical care settings, where timely decision-making is essential.

About the Symphony IL-6 Test:

The Symphony™ Test platform is designed to determine patient acuity for triage and monitoring based on the measurement of a specific biomarker. The Symphony™ IL-6 Test to determine patient acuity for sepsis triage and monitoring (“Symphony™ IL-6 Test”) is currently Bluejay’s lead product candidate.

Note: Investigational device. Limited by United States law to investigational use.

About the SYMON Clinical Study Program:

The SYMON Clinical Study Program includes SYMON-I (clinicaltrials.gov ID NCT06181604), SYMON-II (NCT06654895), and SYMON-III (NCT07425587). SYMON-I is a pilot study to determine IL-6 levels associated with various endpoints, including, but not limited to 28-day all-cause mortality and in-hospital mortality. The SYMON-II study is the pivotal study to validate the outcomes of the SYMON-I study, which the Company plans to use to support a 510(k) application to the FDA. The SYMON-III study is a pilot study to determine IL-6 levels associated with patients presenting with increasing severity of infection in the emergency department and risk of developing sepsis.

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, 2025. 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.
ir@bluejaydx.com
978-631-0310

Website: www.bluejaydx.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How many patients has Bluejay Diagnostics (BJDX) enrolled in the SYMON-II trial as of April 7, 2026?

Bluejay has enrolled 624 patients in SYMON-II as of April 7, 2026. According to the company, the trial’s target enrollment is 750 patients, so enrollment is nearing completion.

When does Bluejay (BJDX) expect to complete enrollment for SYMON-II?

Bluejay expects to complete enrollment within 2–3 months. According to the company, timing remains subject to site activity and patient flow across study locations.

What is the purpose of the SYMON-II trial for Bluejay Diagnostics (BJDX)?

SYMON-II is a pivotal study validating the Symphony™ IL-6 test for sepsis triage and monitoring. According to the company, it aims to provide rapid, near-patient results to guide acute-care decisions.

Has Bluejay (BJDX) reported enrollment problems or exclusions in SYMON-II?

No significant exclusion issues have been reported; the company said inclusion/exclusion criteria have not caused a meaningful number of patient exclusions. Recruitment appears to be progressing as planned.

What are the next steps for Bluejay (BJDX) after completing SYMON-II enrollment?

After enrollment completes, Bluejay anticipates advancing clinical validation and regulatory submission activities. According to the company, these steps align with its strategy for near-patient testing in critical care.