Bluejay Diagnostics' Drug in the FDA Approval Process
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
Interleukin-6. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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 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- Drug:
- Interleukin-6
- Announced Date:
- June 26, 2024
- Indication:
- In patients diagnosed with sepsis and septic shock.
Announcement
Bluejay Diagnostics, Inc. announced results from the primary analysis of SYMON-I, a multicenter pilot clinical study investigating the role of interleukin-6 (IL-6) in patients diagnosed with sepsis and septic shock.
AI Summary
Bluejay Diagnostics, Inc. announced key findings from the primary analysis of the SYMON-I study, a multicenter pilot aimed at understanding the role of interleukin-6 (IL-6) in patients with sepsis and septic shock. The study examined IL-6 levels within 24 hours of sepsis diagnosis and ICU admission, finding that these levels may help predict patient mortality up to 28 days. In contrast, traditional biomarkers like lactate and the Sequential Organ Failure Assessment (SOFA) score did not show the same predictive power.
These promising results suggest that IL-6 could be a valuable biomarker for assessing mortality risk in critically ill patients. Bluejay Diagnostics plans to validate these findings with a follow-up study, SYMON-II, which will further explore IL-6’s role in sepsis management and support future diagnostic development. This research could lead to improved patient triage and outcomes in the fight against sepsis.
Read Announcement
Bluejay Diagnostics FDA Events - Frequently Asked Questions
As of now, Bluejay Diagnostics (BJDX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Bluejay Diagnostics (BJDX) has reported FDA regulatory activity for Interleukin-6.
The most recent FDA-related event for Bluejay Diagnostics occurred on April 15, 2025, involving Interleukin-6. The update was categorized as "Abstract Presentation," with the company reporting: "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."
Currently, Bluejay Diagnostics has one therapy (Interleukin-6) targeting the following condition: In patients diagnosed with sepsis and septic shock..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:BJDX) was last updated on 7/18/2025 by MarketBeat.com Staff
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