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AI brief of an SEC Form 8-K · Bluejay Diagnostics, Inc. (BJDX)

Bluejay Diagnostics Reports SYMON-II Baseline Data: 777 Patients, 18% 28-Day Mortality

Neutral Impact 2 of 5 other Written later

Bluejay Diagnostics released baseline clinical characteristics from its SYMON-II clinical validation study of IL-6 as a biomarker for 28-day mortality risk in sepsis and septic shock. The company says the data do not by themselves establish the test's prognostic performance, and the Symphony IL-6 Test has not been cleared by the FDA and is not available for commercial clinical use in the United States.

Key points

  • Preliminary analysis includes 777 evaluable patients: 637 28-day survivors and 140 28-day non-survivors, an overall mortality rate of approximately 18%.
  • Septic shock was present in 56.4% of non-survivors compared with 35.8% of survivors.
  • The company plans to use SYMON-II, the pivotal study, to support a 510(k) application to the FDA.
  • The Symphony IL-6 Test has not been cleared or approved by the FDA.

The filing

CompanyBluejay Diagnostics, Inc. (BJDX)
Form8-K, current report
Filed with the SECOct 6, 2026, 9:04 AM ET
Accession number0001213900-26-106999

Items reported: 7.01 Regulation FD Disclosure

Read the filing on SEC.gov ↗

Written by AI on Nov 9, 2026, 8:53 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 06, 2026.

Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.