You may have noted a previous update regarding communication with the FDA. Earlier this month, NRx received a request for additional clinical information from the FDA. NRx has responded to the information request issued by the FDA with regard to additional clinical information on study patients. Ongoing conversations between the FDA and sponsor of any application […]
Covid-19
I received a very interesting question the other day regarding the history of aviptadil and any regulatory milestones associated with it as a medicine. Below, I outline a brief history of aviptadil and why we believe it may offer patients suffering respiratory distress the opportunity to regain health and get back home to their families. […]
NRx Pharmaceuticals continues to receive many requests for updates on the status of the US Food and Drug Administration’s (FDA) review of NRx’s application for Emergency Use Authorization (EUA) of ZYESAMI™ (aviptadil), to treat patients suffering from Critical COVID-19 with respiratory failure. On September 3, 2021, NRx received a request for additional clinical information from […]
A year ago, at FDA’s request, NRx began a compassionate care (Expanded Access) program to make aviptadil more available to patients in need. We have reported our experience in nearly 350 patients, and numerous patients and families have shared their stories in various public forums. The compassionate care program was, of necessity, limited to a […]
NRx Has Provided Updated Data to US Food and Drug Administration (FDA) in Support of Emergency Use Authorization Request for ZYESAMI™ (aviptadil) NRx to Submit Breakthrough Therapy Designation to FDA for ZYESAMI™ for the Treatment of Respiratory Failure in Patients with Critical COVID-19 RADNOR, Pa., Aug. 30, 2021 /PRNewswire/ — NRx Pharmaceuticals (NRx) (Nasdaq: NRXP) announced an additional finding […]
Agreement Represents Path to Market for ZYESAMI™, as Time to Treatment is Crucial for Patients Cardinal Health Third Party Logistics Services to Provide Logistical and Distribution Support for ZYESAMI™ (aviptadil) Upon Potential FDA Approval Cardinal Health Specialty Pharmaceutical Distribution to Serve as the Exclusive Distributor to Ensure Access to ZYESAMI™ (aviptadil) Upon Potential FDA Approval […]
RADNOR, Pa., Aug. 24, 2021 /PRNewswire/ — NRx Pharmaceuticals (Nasdaq: NRXP), today announced that it has completed its previously announced private placement for the purchase of 2,727,273 shares of common stock. The Company issued to the investors in the private placement unregistered preferred investment options (the “investment options”) to purchase up to an aggregate of 2,727,273 shares of […]
NRx Pharmaceuticals to lead BriLife Vaccine Trial in Caucasus Region NRx Pharmaceuticals with Support from the Israel Institute for Biological Research to lead BriLife Vaccine Development and Commercialization RADNOR, Pa., Aug. 23, 2021 /PRNewswire/ — NRx Pharmaceuticals (NRx) (Nasdaq: NRXP), a clinical stage, biopharmaceutical company noted today reports1 in the Israeli media that participants in the BriLife vaccine trial who […]
After Review of Approximately 140 patients in ACTIV-3 Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board, Study to Continue Enrollment to Target More than 600 Patients ACTIV-3 Critical Care is a Public-Private Partnership Sponsored by the US National Institutes of Health to Treat COVID-19 ACTIV-3 Critical Care is Evaluating […]