NRx Files for Zyesami Emergency Use in Critical COVID-19 Patients With Respiratory Failure

NRx Pharmaceuticals NRXP has applied with FDA requesting Emergency Use Authorization (EUA) for Zyesami (Aviptadil-acetate) for critically ill COVID-19 patients suffering from respiratory failure.
Consistent with previously announced top-line data, the study identified a statistically significant increase in the likelihood that patients treated with Zyesami would be alive and free of respiratory failure at 60 days, compared to those treated with placebo, and identified a significantly shorter median hospital stay.
The study enrolled 196 participants who were randomized and treated with either Zyesami or placebo, in addition to maximal standard of care at 10 US hospitals.
Patients in earlier stages of respiratory failure (those treated with high flow oxygen) were more likely to survive and recover than those who had already progressed to ventilation.
However, statistically significant benefits in the prespecified endpoint were demonstrated in both groups.
NRx previously requested limited EUA for highly co-morbid COVID-19 patients. FDA further requested randomized, prospective data regarding Zyesami, which are represented in this filing.
Separately, the National Institutes of Health is conducting a confirmatory trial that randomizes patients with COVID-19 respiratory failure to Zyesami versus Gilead Sciences Inc's GILD Veklury (remdesivir) and placebo in a factorial design trial.
A second nationwide trial to determine if similar benefits may be achieved in critically ill patients with inhaled Zyesami is being conducted on the I-SPY platform, maintained by the Quantum Leap Healthcare Collaborative.
Price Action: NRXP shares are down 3.8% at $21.16 during the market session on the last check Tuesday.

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