NRx Pharma Shares Rise 39% After Completing Zyesami Analysis
November 29 2021 - 09:40AM
Dow Jones News
By Chris Wack
NRx Pharmaceuticals Inc. shares were up 39%, to $9.47, in
premarket trading after the company said it has completed an
analysis to identify clinical evidence that indicates a substantial
improvement after treatment with Zyesami aviptadil in patients with
critical Covid-19 and respiratory failure over existing therapies
such as remdesivir.
The analysis showed the subgroup of patients in the trial that
remained in respiratory failure despite treatment with remdesivir.
The analysis identified a statistically-significant 2.5 fold
increased odds of being alive and free of respiratory failure at 60
days and a statistically significant four-fold higher odds of being
alive at day 60 among patients treated with aviptadil compared to
those treated with placebo.
Baseline treatment with remdesivir was prespecified as a
covariate in the protocol agreed to with the U.S. Food and Drug
Administration prior to initiation of the trial and remdesivir
didn't show any independent survival or recovery advantage in the
subgroup. Analysis of the remdesivir-treated subgroup was a
post-hoc analysis performed in response to the FDA's request for
additional clinical evidence that aviptadil may demonstrate a
substantial improvement over existing therapies.
The FDA recently declined Emergency Use Authorization and
Breakthrough Therapy Designation for Zyesami and asked for a new
request based on new clinical evidence that aviptadil may
demonstrate a significant improvement in treatment over existing
therapies.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
November 29, 2021 09:25 ET (14:25 GMT)
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