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

Author: Vandana Singh | November 05, 2021 08:30am

• The FDA has declined the emergency use authorization (EUA) for NRx Pharmaceuticals' (NASDAQ:NRXP) Zyesami (aviptadil). 
• The Company is developing aviptadil in collaboration with Relief Therapeutics Holding SA (OTC: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 (NASDAQ: 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.

Posted In: GILD NRXP RLFTF