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)

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