FDA Declines Emergency Use Authorization for ZYESAMI

NRx Pharmaceuticals

RADNOR, PA — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) announced that the US Food and Drug Administration (FDA) recently declined to issue an Emergency Use Authorization (EUA) for ZYESAMI® (aviptadil) for a sub-group of patients that in addition to ZYESAMI®, also received Remdesivir and continued to progress.

NRx Pharmaceuticals had submitted this last EUA application using data from a post-hoc subgroup analysis.

“As previously communicated, since the futility news of the ACTIV-3b / TESICO Study with ZYESAMI®, our team has already been highly focused on the development of NRX-101 for bipolar depression in patients with Acute and Sub-Acute Suicidality. Though disappointing, this decision by the FDA is not unexpected, given that they had already recently declined Breakthrough Therapy Designation for ZYESAMI®.  We will evaluate the options for ZYESAMI® in COVID-19 respiratory failure and other lung disorders once we receive the full data set from the National Institutes of Health (NIH),” said Robert Besthof, interim CEO, NRx Pharmaceuticals.

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