FDA declines EUA for aviptadil for patients with critical COVID-19 at immediate risk
US clinical-stage biopharma NRx Pharmaceuticals (Nasdaq: NRXP) on Friday announced that the US Food and Drug Administration (FDA) has 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.
Rx Pharmaceuticals had submitted this last EUA application using data from a post-hoc subgroup analysis. The firm’s shares closed down 6.3% to $0.56 by close of trading, though they partly recovered to $0.58 after-hours.
Aviptadil development is partnered with Swiss biotech Relief Therapeutics (SWX: RLF), which has commercialization rights in Europe ad other countries excluding the USA, Canada and Israel, which are NRx’ territories.
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