Shares of NRx Pharmaceuticals (NRXP 2.78%) were skyrocketing 38.4% higher as of 3:11 p.m. EDT on Tuesday. The big jump came after the company announced two positive updates related to pipeline candidate Zyesami.
NRx said that it has submitted a revised Investigational New Drug (IND) module on the manufacturing of Zyesami to the U.S. Food and Drug Administration (FDA). This filing includes documentation confirming Nephron Pharmaceuticals is ready to supply the drug on a commercial scale. In addition, NRx stated that a European inspection at another manufacturing facility for Zyesami has been completed with "no adverse findings."
Both of these developments are important to NRx. They reflect progress toward critical regulatory filings for Zyesami in treating COVID-19-related respiratory failure.
NRx's revised IND module will be used by the FDA as part of its rolling review process for Zyesami. The European inspection is a key prerequisite for the company to file for approvals/authorizations of the drug by the European Union and the United Kingdom.
The really big catalyst for the biotech stock that investors anxiously await is Emergency Use Authorization (EUA) or approval for Zyesami in a major market. NRx has already won EUA for the COVID-19 drug in the nation of Georgia.