Bluejay Diagnostics (BJDX) FDA Approvals $1.71 -0.01 (-0.58%) Closing price 05/19/2026 04:00 PM EasternExtended Trading$1.69 -0.02 (-1.40%) As of 05/19/2026 07:57 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock Bluejay Diagnostics' Drug in the FDA Approval ProcessThis 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 Timeline and 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. Enrollment Update - April 7,2026Enrollment Update Drug: Interleukin-6Announced Date: April 7, 2026Indication: In patients diagnosed with sepsis and septic shock.AnnouncementBluejay 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 AnnouncementAbstract Presentation - April 15,2025Abstract Presentation Drug: Interleukin-6Announced Date: April 15, 2025Indication: In patients diagnosed with sepsis and septic shock.AnnouncementBluejay 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 SummaryBluejay 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 AnnouncementResults - June 26,2024Results Drug: Interleukin-6Announced Date: June 26, 2024Indication: In patients diagnosed with sepsis and septic shock.AnnouncementBluejay 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 SummaryBluejay 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 Has Bluejay Diagnostics received FDA approval? As of now, Bluejay Diagnostics (BJDX) has not received any FDA approvals for its therapy in the last two years. What drugs has Bluejay Diagnostics submitted to the FDA? In the past two years, Bluejay Diagnostics (BJDX) has reported FDA regulatory activity for Interleukin-6. What is the most recent FDA event for Bluejay Diagnostics? The most recent FDA-related event for Bluejay Diagnostics occurred on April 7, 2026, involving Interleukin-6. The update was categorized as "Enrollment Update," with the company reporting: "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." What conditions do Bluejay Diagnostics' current drugs treat? Currently, Bluejay Diagnostics has one therapy (Interleukin-6) targeting the following condition: In patients diagnosed with sepsis and septic shock.. 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FDA EventsBeam Therapeutics FDA EventsBioVie FDA EventsBioMarin Pharmaceutical FDA EventsCullinan Therapeutics FDA EventsDare Bioscience FDA EventsDesign Therapeutics FDA EventsDogwood Therapeutics FDA EventsEnlivex Therapeutics FDA Events 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 Related Companies PAVmed FDA Events Aethlon Medical FDA Events Valion Bio, Inc. Common Stock FDA Events Nuwellis FDA Events Lyra Therapeutics FDA Events Strata Skin Sciences FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:BJDX last updated on 4/7/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersTrump's gold order: the announcement they won't put on the front pageOn August 15, 1971, Nixon interrupted prime-time television and ended the gold standard in 15 minutes - no deb...Reagan Gold Group | SponsoredIran's New Leader Just Said Something That Should Terrify Every AmericanIran's Supreme Leader has declared the Strait of Hormuz closed as leverage against the U.S. - and with 40% of ...American Alternative | SponsoredHey, it's Jon Najarian. The SpaceX IPO is right around the corner. But I discovered Elon may have something BIGGER planned. 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Enrollment Update - April 7,2026Enrollment Update Drug: Interleukin-6Announced Date: April 7, 2026Indication: In patients diagnosed with sepsis and septic shock.AnnouncementBluejay 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
Abstract Presentation - April 15,2025Abstract Presentation Drug: Interleukin-6Announced Date: April 15, 2025Indication: In patients diagnosed with sepsis and septic shock.AnnouncementBluejay 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 SummaryBluejay 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
Results - June 26,2024Results Drug: Interleukin-6Announced Date: June 26, 2024Indication: In patients diagnosed with sepsis and septic shock.AnnouncementBluejay 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 SummaryBluejay 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
