NRx Pharma Stock Nosedives As FDA Strikes Off Its COVID-19 Drug Hopeful

The FDA has declined the emergency use authorization (EUA) for NRx Pharmaceuticals' NRXP Zyesami (aviptadil).
The Company is developing aviptadil in collaboration with Relief Therapeutics Holding SA RLFTF.
The agency stated that it could not issue the EUA due to insufficient data regarding the known and potential benefits & risks of Zyesami in patients suffering from Critical COVID-19 with respiratory failure.
In its letter, the FDA noted that it had reviewed safety in only 131 randomized patients treated with Zyesami.
NRx will attempt to coordinate a review by the FDA of the 150 or more additional patients already treated with Zyesami in the NIH ACTIV-3b trial.
Last week, the study's Data Safety and Monitoring Board reviewed the ongoing NIH ACTIV-3b trial and found no new safety issues.
The US National Institutes of Health (NIH) has enrolled more than 300 patients in the ACTIV-3b trial, a confirmatory study that randomizes patients with COVID-19 respiratory failure to Zyesami® vs. Gilead Sciences Inc GILD Veklury (remdesivir) and placebo.
A second nationwide trial with inhaled Zyesami is being conducted on the I-SPY platform, maintained by the Quantum Leap Healthcare Collaborative.
Related Link: NRx Pharma's COVID-19 Candidate Shows Improved Survival At One Year.
Price Action: NRXP shares are down 34% at $5.92 during the premarket session on the last check Friday.