By Chris Wack
Shares of Bluejay Diagnostics Inc. reversed course on Thursday’s gains, falling 31% to $1.12 a day after it said the Food and Drug Administration had agreed to review its plan to pursue a De Novo bid for his Symphony IL-6 review.
The stock ended Thursday’s session up 26% and hit a 52-week low of 82 cents on March 8.
In written comments to a January submission of an FDA pre-submission information package, the FDA said Bluejay’s Symphony IL-6 test could be considered for the De Novo pathway.
Bluejay said it continues to progress the Symphony IL-6 test toward its planned FDA marketing application, expected by the end of 2022.
If it is determined that a device does not have a legally marketed Class I or Class II device on which to base a determination of substantial equivalence and a device is considered low to moderate risk, the FDA may decide to classify the product candidate as a De Novo application, rather than the more conventional 510(k) marketing application.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswire
June 10, 2022 1:07 p.m. ET (5:07 p.m. GMT)
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