Welcome to our dedicated page for Bluejay Diagnostics news (Ticker: BJDX), a resource for investors and traders seeking the latest updates and insights on Bluejay Diagnostics stock.
Bluejay Diagnostics develops rapid, near-patient diagnostic testing for critical care settings through its Symphony™ platform. The company’s lead product candidate, the Symphony™ IL-6 Test, is designed to measure interleukin-6 for sepsis triage, patient monitoring, and risk assessment, with sample-to-result testing described at approximately 20 minutes.
Bluejay news commonly covers SYMON clinical studies, IL-6 biomarker data, conference presentations, manufacturing readiness for Symphony cartridges, antibody production for test components, and regulatory preparation. Company updates also include financing activity, warrant exercises, reverse stock splits, and other capitalization matters. The Symphony System does not yet have U.S. FDA regulatory clearance and requires authorization before it can be marketed as a diagnostic product in the United States.
Bluejay Diagnostics (NASDAQ: BJDX) announced completion of patient enrollment in its pivotal SYMON-II multicenter clinical validation study evaluating the Symphony™ IL-6 test for early assessment of 28-day all-cause sepsis mortality risk in ICU and ICU-intended patients. The study reached its 750-patient target ahead of the company’s original plan, across leading U.S. healthcare institutions.
Preliminary observations indicate an approximately 17% 28-day mortality rate in the enrolled population, which Bluejay considers a clinically meaningful event rate for assessing IL-6’s prognostic utility. The company expects to complete data cleaning, statistical analysis, and clinical reporting in the coming months, with results planned as a critical component of its regulatory strategy for the Symphony™ IL-6 platform, which remains an investigational device limited to investigational use in the U.S.
Bluejay Diagnostics (NASDAQ:BJDX) closed a private placement raising $8.5 million in gross proceeds through 3,655,917 shares (or pre-funded warrants) plus series G and H warrants.
Bluejay anticipates the net proceeds will fund FDA-related activities and extend its cash runway into the first quarter of 2027.
Bluejay Diagnostics (NASDAQ:BJDX) agreed to a private placement of 3,655,917 common shares (or pre-funded warrants) plus series G and H warrants, raising expected gross proceeds of $8.5 million, with up to $15.1 million additional if all warrants are exercised for cash.
According to Bluejay, net proceeds should extend its cash runway into Q1 2027, beyond the expected FDA submission, and potentially beyond FDA approval and the first full year of commercialization if all warrants are exercised, funding FDA-related activities, R&D, and working capital.
Bluejay Diagnostics (NASDAQ:BJDX) announced a strategic partnership with Argonaut Manufacturing Services to advance its Symphony™ near-patient diagnostic platform for critical care.
The collaboration focuses on building scalable U.S.-based manufacturing, strengthening commercial infrastructure, improving distribution and supply chain resilience, and reducing risks tied to overseas production and import tariffs.
Bluejay Diagnostics (NASDAQ:BJDX) provided a Q1 2026 corporate update on May 7, 2026 covering progress on its Symphony™ near-patient diagnostic platform.
Key points: SYMON-II enrollment at ~680 of 750 target patients as of May 5, 2026; resolved Symphony cartridge manufacturing issues with Sanyoseiko; maintaining objective to prepare a 510(k) submission after analytical and clinical validation; cash ~$3.7M and Q1 net loss ~$1.9M.
Bluejay Diagnostics (NASDAQ: BJDX) announced enrollment of 624 patients in the pivotal SYMON-II trial testing the Symphony™ IL-6 platform for sepsis triage and monitoring.
The study target is 750 patients; the company expects to complete enrollment within 2–3 months, contingent on site activity and patient flow, and noted inclusion/exclusion criteria have not materially limited enrollment.
Bluejay Diagnostics (NASDAQ: BJDX) announced an abstract acceptance for the 2026 SAEM Annual Meeting, May 18–21, 2026 in Atlanta.
The presentation reports SYMON-I pilot results linking emergency department IL-6 levels to organ dysfunction (SOFA) over the first three hospital days and notes the ongoing SYMON-II validation study.
Bluejay Diagnostics (NASDAQ: BJDX) provided a corporate update outlining 2026 priorities: complete the SYMON™ II IL-6 clinical study, advance FDA regulatory submission planning, and scale manufacturing and supply chain readiness for its Symphony platform. The company reported approximately $5.2M cash, $6.0M stockholders' equity, ~972,000 common shares outstanding, and a $6.8M net loss for FY2025. Bluejay completed a $3.8M warrant-inducement financing and a $4.5M PIPE in 2025, converted prefunded warrants without incremental dilution, and expects to raise at least $20M through end of 2027 to support commercialization and operations.
Bluejay Diagnostics (NASDAQ: BJDX) announced that as of Feb 19, 2026 all prefunded warrants from its Oct 2025 private placement were fully exercised, leaving approximately 972,000 shares of common stock outstanding.
The company reports about 1.5 million cash-exercisable warrants remain, each with a cash exercise price of $7.00 or greater, and reminds investors that Schedule 13G filings may show pre-split share counts after the 1-for-4 reverse split on Jan 29, 2026.
Bluejay Diagnostics (NASDAQ: BJDX) enrolled 545 patients in the SYMON II multicenter IL-6 monitoring study, toward a 750-patient target, and advanced manufacturing readiness into 2026. Key manufacturing milestones include cartridge characterization for U.S. commercial production and antibody supply sufficient for more than 10 million test cartridges.
The company is progressing technology transfer, analytical validation, and fabrication under defined protocols while noting the Symphony System does not yet have FDA clearance and requires authorization before U.S. marketing.