This section highlights FDA-related milestones and regulatory updates for drugs developed by Bluejay Diagnostics (BJDX).
Over the past two years, Bluejay Diagnostics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Symphony, SYMON-II, and Interleukin-6. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Symphony IL-6 Test FDA Regulatory Events
Symphony IL-6 Test is a drug developed by Bluejay Diagnostics for the following indication: Sepsis triage.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Symphony IL-6 Test
- Announced Date:
- October 6, 2026
- Indication:
- Sepsis triage
Announcement
Bluejay Diagnostics, Inc. 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.
Read Announcement
SYMON-II FDA Regulatory Events
SYMON-II is a drug developed by Bluejay Diagnostics for the following indication: Multicenter Clinical Validation Study.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SYMON-II
- Announced Date:
- July 21, 2026
- Indication:
- Multicenter Clinical Validation Study
Announcement
Bluejay Diagnostics, Inc announced the successful completion of patient enrollment in its SYMON-II multicenter clinical validation study..
AI Summary
Bluejay Diagnostics said it has successfully finished patient enrollment in its SYMON-II multicenter clinical validation study. The study is designed to test the prognostic value of IL-6 in people arriving with sepsis. Early observations from the enrolled patients showed about a 17% 28-day mortality rate, which Bluejay said makes the group strong for evaluating how well IL-6 can identify patients at higher risk of getting worse.
The company expects to finish data cleaning, statistical analysis, and clinical reporting in the coming months. Bluejay said the study results will be an important part of its planned regulatory strategy for the Symphony™ IL-6 platform. The Symphony™ system is built to give fast biomarker results near the patient’s bedside and support decisions in emergency rooms, intensive care units, and other critical care settings. Completion of SYMON-II enrollment is another step toward regulatory submission and future commercialization.
Read Announcement
Interleukin-6 FDA Regulatory Events
Interleukin-6 is a drug developed by Bluejay Diagnostics for the following indication: In patients diagnosed with sepsis and septic shock.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Interleukin-6
- Announced Date:
- April 7, 2026
- Indication:
- In patients diagnosed with sepsis and septic shock.
Announcement
Bluejay Diagnostics, Inc. 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.
Read Announcement- Drug:
- Interleukin-6
- Announced Date:
- April 15, 2025
- Indication:
- In patients diagnosed with sepsis and septic shock.
Announcement
Bluejay Diagnostics, Inc. announced acceptance of an abstract related to the Symphony IL-6 Test, the company's lead product candidate, for presentation at the Society of Academic Emergency Medicine (SAEM) Annual Meeting, taking place in Philadelphia May 13-16, 2025.
AI Summary
Bluejay Diagnostics, Inc. announced that an abstract detailing the Symphony IL-6 Test, its lead product candidate, has been accepted for presentation at the SAEM Annual Meeting in Philadelphia from May 13-16, 2025. This abstract is based on the SYMON-I pilot clinical study, which examines the role of interleukin‑6 (IL‑6) in sepsis patients. The study assessed IL‑6 levels as an early indicator to predict 28-day and 7-day mortality rates, as well as microbiological outcomes.
The upcoming presentation will allow emergency medicine professionals to gain insights into how the Symphony IL‑6 Test could serve as a valuable tool for early diagnosis and management of sepsis. This development marks a significant step forward in deploying rapid biomarker testing in the clinical setting, aiming to improve patient triage and care in critical situations.
Read Announcement
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