Form 8-K

8-K — Bluejay Diagnostics, Inc.

Accession: 0001213900-26-040728

Filed: 2026-04-07

Period: 2026-04-07

CIK: 0001704287

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — ea0285343-8k_bluejay.htm (Primary)

EX-99.1 — PRESS RELEASE, DATED APRIL 7, 2026 (ea028534301ex99-1.htm)

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8-K — CURRENT REPORT

8-K (Primary)

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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):

April 7, 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)

(844) 327-7078

(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 7.01 Regulation FD Disclosure.

On April 7, 2026, Bluejay Diagnostics, Inc. (the

“Company”) issued a press release providing an update regarding the status of patient enrollment in its ongoing SYMON-II clinical

trial.

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 April 7, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

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: April 7, 2026

EX-99.1 — PRESS RELEASE, DATED APRIL 7, 2026

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Exhibit 99.1

Bluejay Diagnostics, Inc. Announces Completion of 624 Patient Enrollments

in SYMON-II Pivotal Clinical Trial

Acton, Massachusetts — April 7, 2026 — 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 SymphonyTM Test platform is designed to determine patient

acuity for triage and monitoring based on the measurement of a specific biomarker. The SymphonyTM IL-6 Test to determine patient

acuity for sepsis triage and monitoring (“SymphonyTM 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

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