InflaRx Shares Rally on Plans to Seek FDA Emergency-Use Authorization for Vilobelimab
July 26 2022 - 10:52AM
Dow Jones News
By Colin Kellaher
Shares of InflaRx NV rose more than 20% on Tuesday after the
clinical-stage biopharmaceutical company outlined plans to seek
U.S. Food and Drug Administration emergency-use authorization for
its investigational drug vilobelimab in patients with severe
Covid-19.
The Jena, Germany-based company said that following a meeting
with the FDA to discuss a potential submission and the development
of vilobelimab in mechanically ventilated Covid-19 patients, it
plans to submit its request for an emergency-use authorization by
the end of the third quarter.
InflaRx in late March said the Phase 3 portion of a Phase 2/3
study of vilobelimab in mechanically ventilated Covid-19 patients
showed a relative reduction in 28-day all-cause mortality of 23.9%,
which the company said was encouraging but not statistically
significant under the study's prespecified primary endpoint.
InflaRx shares were recently changing hands at $1.68, up
21%.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
July 26, 2022 10:37 ET (14:37 GMT)
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