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) will implement a board-approved 1-for-4 reverse stock split effective November 3, 2026, at 12:01 a.m. Eastern Time.
Split-adjusted trading will begin on The Nasdaq Capital Market that day. Outstanding common shares will decrease from approximately 4,468,051 to 1,117,013, while common shares issuable upon exercise of prefunded warrants will decrease from 222,581 to 55,645. Shares underlying outstanding equity awards and warrants will also be adjusted. Ownership percentages will remain unchanged except for adjustments arising from fractional shares, which will be paid in cash rather than issued.
Bluejay Diagnostics (BJDX) completed establishment of a Symphony cartridge manufacturing site, meeting a contractual milestone under its amended Toray Industries license agreement.
The milestone was achieved ahead of the October 23, 2026 deadline, and Bluejay formally notified Toray that its obligation to substantially complete site establishment had been fulfilled. SanyoSeiko in Japan serves as the contractual manufacturing site. Bluejay is developing complementary manufacturing capabilities there and with ALURIS Sciences in the United States, intended to reduce reliance on a single manufacturing pathway. Manufacturing scale-up continues alongside the regulatory program for the Symphony IL-6 Test. The test has not received FDA clearance or approval and is not available for commercial clinical use in the United States.
Bluejay Diagnostics (BJDX) announced baseline data from its SYMON-II clinical validation study, whose preliminary analysis includes 777 evaluable sepsis patients. The dataset includes 637 survivors and 140 non-survivors at 28 days, an overall mortality rate of approximately 18%. Septic shock under Sepsis-3 criteria affected 39.5% of patients; shock was present in 56.4% of non-survivors versus 35.8% of survivors.
The study evaluates interleukin-6 (IL-6), a biological marker, in relation to 28-day mortality risk. Analysis of samples and IL-6 measurements continues. These baseline data do not establish prognostic performance, clinical utility, sensitivity, specificity or regulatory acceptability; those conclusions depend on completing planned analyses. Bluejay plans to use SYMON-II to support an FDA 510(k) application. The Symphony IL-6 Test is not FDA-cleared or approved and is not available for commercial clinical use in the United States.
Bluejay Diagnostics (BJDX) signed a distribution, co-marketing and strategic partnership with Lovell Government Services to prepare access to U.S. federal healthcare markets, effective for products that receive applicable FDA clearance or other required regulatory authorization.
Lovell will be Bluejay’s exclusive distributor for federal procurement opportunities that require or favor Service-Disabled Veteran-Owned Small Business set-aside or preferred status, including the VA, DoD, Military Health Systems and Indian Health Service, and will have non-exclusive rights for other federal, state and local opportunities. The collaboration aims to leverage Lovell’s federal contract vehicles such as VA FSS, GSA MAS, DLA DAPA and ECAT, as well as its AMSUS relationships. The framework is part of Bluejay’s strategy to build commercialization capabilities in parallel with its SYMON clinical study program and ongoing FDA 510(k) plans for the Symphony IL-6 sepsis test.
Bluejay Diagnostics (NASDAQ: BJDX) reported Q2 2026 results and operational progress, highlighting advancement of its Symphony™ IL-6 rapid diagnostic platform. The company completed targeted enrollment of 750 hospital patients in its SYMON-II pivotal clinical validation study and is moving into analytical and clinical validation to support a planned FDA 510(k) submission.
According to Bluejay, a US manufacturing contract has been signed to mitigate supply-chain risk as the company prepares for potential commercialization. The company ended June 30, 2026 with approximately $9.6 million in cash and cash equivalents, up from about $5.2 million at December 31, 2025, supported by roughly $7.7 million of net cash from financing in the first half, including about $7.6 million from a June 2026 private placement. Current cash resources are estimated to fund operations through the second quarter of 2027. Symphony remains an investigational device, limited by US law to investigational use.
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.