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.