NRx Pharma Shares Slip After FDA Declines EUA for Zyesami in Subgroup of Covid Patients
July 01 2022 - 8:31AM
Dow Jones News
By Michael Dabaie
NRx Pharmaceuticals Inc. shares were down 1.7% to $59 premarket
after the clinical-stage biopharmaceutical company said the U.S.
Food and Drug Administration declined to issue emergency use
authorization for Zyesami for a sub-group of patients with critical
Covid-19.
The development follows the FDA denying breakthrough therapy
designation for Zyesami, or aviptadil.
In June, NRx said the FDA denied the breakthrough therapy
designation and the company emphasized its focus on the NRX-101 BTD
compound for bipolar depression associated with suicidality.
The company said it submitted the request for breakthrough
designation based on the positive finding of a post-hoc subgroup
analysis of patients who in addition to aviptadil or placebo were
also treated with Remdesivir and whose respiratory failure due to
critical Covid-19 continued to progress.
"Though disappointing, this decision by the FDA is not
unexpected, given that they had already recently declined
breakthrough therapy designation for Zyesami," interim Chief
Executive Robert Besthof said Friday. "We will evaluate the options
for Zyesami in CovidD-19 respiratory failure and other lung
disorders once we receive the full data set from the National
Institutes of Health."
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
July 01, 2022 08:16 ET (12:16 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
NRX Pharmaceuticals (NASDAQ:NRXP)
Historical Stock Chart
From Sep 2024 to Oct 2024
NRX Pharmaceuticals (NASDAQ:NRXP)
Historical Stock Chart
From Oct 2023 to Oct 2024