Why Are NRx Pharma's Shares Soaring Premarket?

NRx Pharmaceuticals NRXP has completed an analysis in the subgroup of Zyesami and placebo-treated patients previously treated with Gilead Science Inc's GILD remdesivir in the COVID-AIV trial representing approximately 70% of the study population.

• The analysis indicates a substantial improvement after Zyesami (aviptadil) treatment in patients with critical COVID-19 and Respiratory Failure over existing therapies. 
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• The analysis identified a statistically significant 2.5 fold increased odds of being alive and free of respiratory failure at 60 days (the primary endpoint) and a statistically significant four-fold higher odds of being alive at day 60 among patients treated with aviptadil compared to those treated with placebo.
• Baseline treatment with remdesivir was prespecified as a covariate in the protocol agreed to with the FDA. Before initiation of the trial, remdesivir did not show any independent survival or recovery advantage in the subgroup. 
• The FDA recently declined Emergency Use Authorization and Breakthrough Therapy Designation for Zyesami and invited a new request based on new clinical evidence.
• Price Action: NRXP shares are up 52% at $10.26 during the premarket session on the last check Monday.