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US manufacturing pact backs Bluejay (NASDAQ: BJDX) Symphony platform

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Bluejay Diagnostics, Inc. entered a material definitive agreement with Argonaut Manufacturing Services to provide U.S.-based manufacturing and related services for Bluejay’s Symphony™ platform IL-6 testing products. Argonaut will support planning, engineering, sourcing, supply chain management, formulation, filling, finishing, quality control testing, capital equipment procurement, storage, delivery, and distribution under purchase orders issued over time.

The partnership is intended to establish scalable domestic manufacturing, reduce reliance on overseas production, and strengthen Bluejay’s future commercial infrastructure, including broader U.S. product distribution and greater supply chain resilience. The collaboration supports Bluejay’s ongoing clinical development programs and future commercialization plans for its near-patient diagnostic solutions.

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Item 1.01 Entry into a Material Definitive Agreement Business
The company signed a significant contract such as a merger agreement, credit facility, or major partnership.
Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
SYMON-I identifier NCT06181604 Clinicaltrials.gov ID for SYMON-I pilot study
SYMON-II identifier NCT06654895 Pivotal study to support 510(k) submission
SYMON-III identifier NCT07425587 Pilot study on infection severity and sepsis risk
Key mortality endpoint horizon 28-day all-cause mortality SYMON-I pilot study clinical endpoint
Symphony IL-6 test time Approximately 20 minutes Sample-to-result time for IL-6 sepsis test
material definitive agreement regulatory
"Item 1.01 Entry into a Material Definitive Agreement."
A material definitive agreement is a legally binding contract that creates major, long‑term obligations or rights for a company, such as loans, asset sales, mergers, or supplier deals. Think of it like a mortgage or lease for a business: it can change future cash flow, risk and control, so investors watch these agreements closely because they can materially affect a company’s value, financial health and stock price.
Regulation FD Disclosure regulatory
"Item 7.01 Regulation FD Disclosure."
Regulation FD disclosure requires public companies to share important, market-moving information with everyone at the same time instead of tipping off analysts or large investors first. Think of it as making sure all players on a field hear the same announcement simultaneously; that fairness helps investors trust that stock prices reflect the same information and reduces the risk of sudden, unfair trading advantages or regulatory penalties for selective leaks.
510(k) application regulatory
"which the Company plans to use to support a 510(k) application to the FDA."
A 510(k) application is a regulatory submission to the U.S. Food and Drug Administration showing that a new medical device is substantially similar to an already approved device, so it can be cleared for marketing without the longest, most rigorous approval process. For investors, a cleared 510(k) means faster, lower-cost market access and lower regulatory risk compared with full approvals, which can speed revenue and reduce uncertainty — like getting permission to sell a new model because it’s close to an existing one.
near-patient testing financial
"a medical diagnostics company focused on near-patient testing for critical care"
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.
forward-looking statements regulatory
"This press release contains statements that the Company believes are “forward-looking statements”"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
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false 0001704287 0001704287 2026-05-27 2026-05-27 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): May 27, 2026

 

 

 

 

BLUEJAY DIAGNOSTICS, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

 

delaware   001-41031   47-3552922

(State or Other Jurisdiction of

Incorporation or Organization)

  (Commission File No.)  

(I.R.S. Employer

Identification No.)

 

360 Massachusetts Avenue, Suite 203

Acton, MA 01720

(Address of principal executive offices and zip code)

 

(844327-7078

(Registrant’s telephone number, including area code)

 

 

(Former name or former address, if changed from last report)

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-14(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol (s)   Name of each exchange on which registered
Common Stock, par value $0.0001 per share   BJDX   The Nasdaq Stock Market LLC

 

 

 

 

 

Item 1.01 Entry into a Material Definitive Agreement.

 

On May 27, 2026, Bluejay Diagnostics, Inc. (the “Company”) entered into an agreement and statement of work (together, the “Agreement”) with Argonaut Manufacturing Services c/o Argonaut, Inc. (“Argonaut”) regarding the provision by Argonaut to the Company of certain manufacturing services to support the Company’s Symphony™ platform. The services include planning, engineering, sourcing, supply chain management, formulation, filling, finishing, quality control testing, procurement of capital equipment and product storage, delivery and distribution relating to the Company’s IL-6 testing products. All services under the Agreement are to be performed pursuant to terms contained in purchase orders to be provided by the Company to Argonaut from time-to-time.

 

The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of such agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 7.01 Regulation FD Disclosure.

 

On June 2, 2026, the Company issued a press release in connection with the matters discussed herein under item 1.01. 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, 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

 

10.1   Agreement dated May 27, 2026, between Bluejay Diagnostics, Inc. and Argonaut Manufacturing Services
99.1   Press Release, dated June 2, 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: June 2, 2026

 

2

 

Exhibit 99.1

 

 

 

Bluejay Diagnostics and Argonaut Manufacturing Services Announce Strategic Partnership

 

ACTON, MA/CARLSBAD, CA., June 2, 2026 — Bluejay Diagnostics, Inc. (“Bluejay” or the “Company”) (NASDAQ: BJDX), a medical diagnostics company focused on near-patient testing for critical care, today announced a strategic partnership with Argonaut Manufacturing Services (“Argonaut”) to support the advancement of Bluejay’s Symphony™ platform.

 

This partnership is designed to support Bluejay’s broader efforts to establish scalable U.S.-based manufacturing capabilities aligned with its ongoing clinical development programs and future commercialization objectives. In addition, the partnership is intended to strengthen Bluejay’s future commercial infrastructure by supporting broader product distribution across the United States, enhancing supply chain resilience, and reducing potential risks associated with international sourcing and import tariffs. The collaboration is also intended to mitigate risks associated with Bluejay’s current reliance on overseas manufacturing by establishing domestic manufacturing capabilities that can provide greater operational control, business continuity, and supply chain security. By leveraging U.S.-based manufacturing and distribution capabilities, Bluejay aims to improve operational flexibility, support future market demand, and further enhance its ability to commercialize innovative near-patient diagnostic solutions for critical care settings.

 

“We are pleased to partner with Argonaut as we continue to advance the Symphony™ platform,” said Neil Dey, President and Chief Executive Officer of Bluejay Diagnostics. “This collaboration reflects our commitment to building a scalable and quality-focused operational foundation as we progress toward key commercial milestones.”

 

“Argonaut is committed to partnering with innovative companies to support the advancement of differentiated diagnostic technologies,” said Rick Hancock, Chief Executive Officer of Argonaut Manufacturing Services. “We value this collaboration with Bluejay Diagnostics and look forward to supporting their efforts as they continue to develop solutions aimed at improving clinical decision-making in critical care settings.”

 

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.

 

About Argonaut Manufacturing Services:

 

Argonaut Manufacturing Services is a contract manufacturing organization focused on supporting life sciences and diagnostics companies with high-quality manufacturing solutions. Founded by former executives from companies such as Thermo Fisher Scientific, Affymetrix, and Allergan, Argonaut was built to provide a better, customer-focused approach to contract manufacturing.

 

The company’s mission is centered on improving the human condition by helping partners bring innovative healthcare products to market efficiently and reliably. Drawing from decades of industry experience, Argonaut emphasizes quality, operational excellence, and strong customer collaboration to help clients achieve their commercial and development goals in the health and life sciences industries.

 

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, and in Part II, Item 1A, “Risk Factors” in its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2026. 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

 

Website: www.bluejaydx.com

 

 

 

 

FAQ

What agreement did Bluejay Diagnostics (BJDX) enter with Argonaut?

Bluejay Diagnostics entered a material definitive agreement with Argonaut Manufacturing Services to provide manufacturing and related services for its Symphony IL-6 testing products, covering planning, production, quality control, and distribution under purchase orders issued over time.

How does the Argonaut partnership support Bluejay Diagnostics’ Symphony platform?

The partnership supports Bluejay’s Symphony platform by providing U.S.-based manufacturing, supply chain management, formulation, filling, finishing, and quality control testing, helping build a scalable operational foundation for future commercialization of the company’s near-patient IL-6 diagnostic test.

Why is Bluejay Diagnostics focusing on U.S.-based manufacturing with Argonaut?

Bluejay is focusing on U.S.-based manufacturing to reduce reliance on overseas production, enhance supply chain resilience, improve operational control and business continuity, and better support future market demand for its Symphony near-patient diagnostic solutions in critical care settings.

What regulatory pathway does Bluejay Diagnostics plan for its IL-6 test?

Bluejay plans to use data from its SYMON-II pivotal study to support a 510(k) application to the U.S. Food and Drug Administration, seeking clearance for its Symphony IL-6 test designed for rapid, near-patient sepsis triage and monitoring in critical care environments.

What is the SYMON Clinical Study Program mentioned by Bluejay Diagnostics (BJDX)?

The SYMON Clinical Study Program includes SYMON-I, SYMON-II, and SYMON-III. These studies assess IL-6 levels in relation to outcomes like 28-day all-cause mortality, in-hospital mortality, infection severity, and sepsis risk, supporting clinical validation and regulatory submissions for Bluejay’s IL-6 test.

Has Bluejay Diagnostics’ Symphony System received FDA clearance yet?

Bluejay Diagnostics’ Symphony System has not yet received FDA regulatory clearance. The company must obtain authorization before marketing Symphony as a diagnostic product in the United States and is conducting SYMON clinical studies to support a future 510(k) submission.

Filing Exhibits & Attachments

5 documents