FDA Turns Down NRx Pharmaceuticals' Emergency Use Submission For Covid-19 Candidate

The U.S. Food and Drug Administration (FDA) has declined to issue an Emergency Use Authorization (EUA) for NRx Pharmaceuticals’  NRXP lead drug ZYESAMI (aviptadil) for subgroup of patients with critical COVID-19 at immediate risk of death from respiratory failure despite treatment with approved therapy, including remdesivir.

The Emergency Use Authorization (EUA) application was supported by data readout from a post-hoc subgroup analysis.

Robert Besthof, interim CEO, commented : "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).”

The company said that team NRx has been highly focused on the development of NRX-101 for bipolar depression in patients with Acute and Sub-Acute Suicidality.

NRx Pharmaceuticals shares are trading high 1 percent at $0.61 on Friday during pre-market session.