Common Stock, par value $0.0001 per share
- Symbol
- BJDX
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 7.01, 9.01 · 8-K
Bluejay Diagnostics, Inc.
BJDXNASDAQEQUITYCurrent
Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure. On October 6, 2026, Bluejay Diagnostics, Inc. issued a press release regarding baseline clinical characteristics from its SYMON-II clinical validation study.…
Company context
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.
Current securities
Registered securities in this filing
BLUEJAY DIAGNOSTICS, INC. · 8-K · Filed 2026-10-06
Disclosure sections
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On October 6, 2026, Bluejay
Diagnostics, Inc. issued a press release regarding baseline clinical characteristics from its SYMON-II clinical validation study.
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
99.1 Press Release, dated October 6, 2026.
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
Filed exhibits (1)
Exhibit 99.1 For Immediate Release Bluejay Diagnostics Announces SYMON-II Clinical Dataset Details Supporting Evaluation of Mortality Risk in Sepsis and Septic Shock. SYMON-II Clinical Validation Dataset Represents a Key Milestone as Bluejay Advances the Symphony™ IL-6 Test Toward Regulatory Submission ACTON, Mass. October 6, 2026 - Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay” or the “Company”), a medical diagnostics company focused on improving patient outcomes through its Symphony™ near-patient diagnostic platform, today announced baseline clinical characteristics from the SYMON-II clinical validation study, highlighting a substantial and diverse population of critically ill patients and clinically meaningful mortality events for evaluating interleukin-6 (“IL-6”) as a biomarker associated with 28-day mortality risk in patients with sepsis and septic shock. The current preliminary SYMON-II analysis includes 777 evaluable patients, consisting of 637 28-day survivors and 140 28-day non-survivors, representing an overall 28-day mortality rate of approximately 18%. The study population included patients across a broad spectrum of illness severity, ethnicity and geographica…
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