What's Next For NRx Pharma As FDA Denies Breakthrough Therapy Tag For COVID-19 Therapy

The FDA has denied NRx Pharmaceuticals Inc's NRXP Breakthrough Therapy designation (BTD) request for Zyesami (aviptadil).
The request for BTD was submitted based on a post-hoc subgroup analysis of patients who, in addition to aviptadil or placebo, were also treated with Gilead Sciences Inc's GILD remdesivir and whose respiratory failure due to critical COVID-19 continued to progress.
Related: Why NRX Pharmaceuticals Shares Are Trading Lower During Premarket On Thursday?
The company emphasized its focus on the company's NRX-101 BTD compound for Bipolar Depression associated with Suicidality.
It expects topline data from the Phase 2 study of NRX-101 in patients with bipolar depression with sub-acute suicidal ideation (SSIB) by the end of the year.
"Given ZYESAMI's mechanism and its well-characterized safety profile, NRx Pharmaceuticals will further evaluate the options for its use in other high unmet pulmonary and non-pulmonary indications," said Robert Besthof, interim CEO of NRx Pharma.
Price Action: NRXP shares are down 0.85% at $0.57 during the premarket session on the last check Monday.