The U.S. Food and Drug Administration (FDA) has declined to issue an Emergency Use Authorization (EUA) for NRx Pharmaceuticals’ (NASDAQ: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.
