Bluejay completes 750-patient sepsis study enrollment
- Bluejay completed enrollment of 750 patients in its pivotal SYMON-II sepsis study ahead of its original schedule.
- Bluejay shares fell 14.8% to $1.21 in premarket trading following the announcement.
- The company plans to analyse the data for its regulatory strategy, but the Symphony IL-6 test remains investigational.
Bluejay Diagnostics (NASDAQ:BJDX) completed enrollment of 750 patients in its SYMON-II study evaluating 28-day sepsis mortality risk.
Enrollment increased from approximately 680 patients on May 5 and reached the final target earlier than Bluejay had originally planned.
Bluejay observed an approximately 17% mortality rate, but sensitivity, specificity and other test-performance results remain pending statistical analysis.
Following the announcement, Bluejay Diagnostics' share price was down 14.8% at $1.21 in premarket trading.
SYMON-II is intended to validate earlier SYMON-I findings and support a planned 510(k) application to the U.S. Food and Drug Administration.
Recent moves include an $8.5 million private placement, a manufacturing partnership with Argonaut and continued development of a roughly 20-minute near-patient test.
