NRx Pharmaceuticals Again Requests For FDA Breakthrough Therapy Status For COVID-19 Therapy

  • NRx Pharmaceuticals Inc NRXP has filed a new Breakthrough Therapy designation request with the FDA for Zyesami focused on a subgroup of critical COVID-19 patients.
  • The subgroup includes patients who were also treated with Gilead Sciences Inc's GILD Veklury (remdesivir) in addition to aviptadil or placebo. 
  • The request includes safety data on approximately 750 patients treated with intravenous Zyesami for Critical COVID-19.
  • NRx Pharmaceuticals submitted a Breakthrough Therapy designation request in 2021, which the FDA did not grant
  • In its reply, the FDA requested new clinical evidence comparing the safety and efficacy of aviptadil relative to other existing therapies.
  • NRx Pharmaceuticals performed a post-hoc analysis of its completed Phase 2b/3 study focused on approximately 70% of patients based on the FDA's input.
  • Read Next: NRx Pharma Says I-SPY Study Of Inhaled Zyesami In Critical COVID-19 Stopped.
  • Zyesami showed a highly significant four-fold increased odds of survival compared to placebo at 60 days (P=.006). 
  • In February, NRx Pharmaceuticals submitted a new Emergency Use Authorization request focused on this narrower patient population.
  • Price Action: NRXP shares are down 7.28% at $1.98 during the market session on the last check Thursday.

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