Bluejay Diagnostics Successfully Enrolls 545 Patients in SYMON™ II Study and Advances Manufacturing Readiness into 2026

Rhea-AI Summary

Bluejay Diagnostics (NASDAQ: BJDX) enrolled 545 patients in the SYMON II multicenter IL-6 monitoring study, toward a 750-patient target, and advanced manufacturing readiness into 2026. Key manufacturing milestones include cartridge characterization for U.S. commercial production and antibody supply sufficient for more than 10 million test cartridges.

The company is progressing technology transfer, analytical validation, and fabrication under defined protocols while noting the Symphony System does not yet have FDA clearance and requires authorization before U.S. marketing.

Positive

• Enrollment of 545 patients toward a 750-patient SYMON II target
• Antibody supply capacity sufficient for more than 10 million test cartridges
• Cartridge characterization completed to support U.S. commercial production

Negative

• Enrollment incomplete: 545 of 750 target patients remain to be enrolled
• No FDA clearance yet for the Symphony System; regulatory authorization still required

Key Figures

Patients enrolled: 545 patients Enrollment target: 750 patients Cartridge capacity: more than 10 million test cartridges +1 more

4 metrics

Patients enrolled 545 patients SYMON™ II multicenter IL-6 monitoring study enrollment to date

Enrollment target 750 patients Planned total enrollment for SYMON™ II study

Cartridge capacity more than 10 million test cartridges Antibody supply capacity for commercial manufacturing

Test turnaround time approximately 20 minutes Symphony IL-6 sepsis test sample-to-result time

Market Reality Check

Price: $2.67 Vol: Volume 70,640 is below th...

low vol

$2.67 Last Close

Volume Volume 70,640 is below the 20-day average of 146,003, indicating muted pre-news trading interest. low

Technical Price $2.67 is trading below the 200-day MA ($5.95), reflecting a weak longer-term trend ahead of this update.

Peers on Argus

BJDX was down 1.84% pre-news while key peers were mixed: VTAK -13.33%, NUWE -2.4...

BJDX was down 1.84% pre-news while key peers were mixed: VTAK -13.33%, NUWE -2.48%, BBLG -0.58%, TIVC +1.85%, AEMD 0%. Moves do not indicate a unified sector trend.

Historical Context

5 past events · Latest: Jan 27 (Negative)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 27	Reverse stock split	Negative	-3.9%	1-for-4 reverse split reduced outstanding common shares significantly.
Dec 29	Manufacturing progress	Positive	-3.0%	Completion of commercial-scale IL-6 antibody production for Symphony cartridges.
Nov 10	Corporate update	Neutral	+0.0%	Q3 results with SYMON-II progress and financing updates, including PIPE and warrants.
Oct 10	Private placement close	Negative	-2.7%	Closing of $4.5M private placement with new common shares and Series F warrants.
Oct 09	Private placement deal	Negative	+75.4%	Announcement of $4.5M private placement priced at-the-market under Nasdaq rules.

Pattern Detected

Recent news often coincided with negative or flat price reactions, including financings and the reverse split, with one notable upside move on a private placement announcement.

Recent Company History

Over the last few months, Bluejay reported several capital markets and operational milestones. A 1-for-4 reverse split on Jan 27, 2026 saw shares fall 3.87%. Antibody production completion on Dec 29, 2025 was followed by a 3% decline. A Q3 2025 update on Nov 10, 2025 produced a flat move. Private placement news on Oct 9–10, 2025 showed contrasting reactions, including a large +75.4% spike, underscoring historically volatile responses to financing-related events.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-10-23

An effective S-3 shelf dated Oct 23, 2025 registers 6,930,000 common shares for resale by selling stockholders. The company does not sell shares directly in this registration and receives proceeds only if associated warrants are exercised for cash.

Market Pulse Summary

This announcement highlights substantial advancement of the SYMON™ II program, with 545 of a targete...

Analysis

This announcement highlights substantial advancement of the SYMON™ II program, with 545 of a targeted 750 patients enrolled and manufacturing readiness scaled to support over 10 million cartridges. These steps build on prior antibody production and corporate updates, moving the Symphony IL-6 test closer to regulatory engagement and commercialization. Investors may watch for final enrollment, data readouts, FDA submission progress, and any additional capital-raising or structural actions disclosed in future filings.

Key Terms

il-6, irb, monoclonal, technology transfer, +2 more

6 terms

il-6 medical

"SYMON™ II multicenter IL-6 monitoring study, with a total of 545 patients"

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.

irb regulatory

"All enrollments are under approved IRB protocols."

An Institutional Review Board (IRB) is an independent committee that reviews and approves medical and behavioral research involving people to ensure safety, informed consent, and ethical treatment—think of it as a safety inspector for studies. For investors, IRB decisions matter because their approval or requests for changes can speed up, delay, or halt clinical trials and other studies, directly affecting timelines, costs, and the value of companies developing treatments.

monoclonal medical

"Completion of monoclonal and polyclonal antibody production, providing supply capacity"

Monoclonal describes a therapeutic product or laboratory reagent made from a single original cell, so every molecule or antibody in the batch is virtually identical. Investors care because that uniformity usually means predictable behavior, easier quality control, clearer regulatory approval paths and stronger intellectual property; think of it like manufacturing identical keys rather than cutting many different ones by hand, which reduces surprises and supports reliable production and pricing.

technology transfer technical

"technology transfer initiatives into 2026, representing a key execution milestone"

Technology transfer is the process of moving an invention, know‑how, or technical capability from one organization to another so it can be developed, manufactured or sold. For investors it matters because successful transfers turn research or prototypes into marketable products or revenue streams—similar to handing a recipe and kitchen to someone who can scale it up—and they affect a company’s growth prospects, costs, timelines and competitive position.

fda regulatory

"validation of cartridge and reservoir for FDA submission and commercialization"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

near-patient testing technical

"a cost-effective, rapid, near-patient testing system for sepsis triage"

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. Not financial advice.

ACTON, Mass., Feb. 17, 2026 (GLOBE NEWSWIRE) -- 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

How many patients has Bluejay Diagnostics (BJDX) enrolled in the SYMON II study as of Feb 17, 2026?

Bluejay has enrolled 545 patients in SYMON II as of Feb 17, 2026. According to the company, this progress moves the study toward its 750-patient target and reduces enrollment execution risk ahead of data analysis and regulatory engagement.

What manufacturing milestones did BJDX announce for 2026 and commercial readiness?

BJDX completed cartridge characterization and advanced technology transfer workstreams into 2026. According to the company, efforts include tooling, analytical validation, and fabrication aimed at supporting U.S. commercial production and scale-up readiness.

Does the Bluejay Symphony System have FDA clearance for the IL-6 test (BJDX)?

No, the Symphony System does not yet have FDA clearance and needs authorization before U.S. marketing. According to the company, regulatory engagement and data analysis are next steps before potential approval and commercialization.

How large is Bluejay's antibody supply and what does it imply for BJDX production capacity?

Bluejay reports monoclonal and polyclonal antibody production sufficient for > 10 million test cartridges. According to the company, that supply capacity is intended to support commercial demand and scale manufacturing if authorized.

What is the remaining enrollment gap and timeline risk for BJDX's SYMON II study?

BJDX has enrolled 545 of the 750 planned patients, leaving a 205-patient gap to meet the target. According to the company, remaining enrollment and subsequent data analysis are the main near-term milestones before regulatory interactions.