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 […]
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 […]
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 […]
Emergency Use Authorization (EUA) Request for ZYESAMI™ (aviptadil) Pending with United States Food and Drug Administration to Treat Patients Suffering from Critical COVID-19 with Respiratory Failure Emergency Use Authorization Granted to ZYESAMI in Nation of Georgia to Treat Critical COVID-19 Patients in July; First Orders for ZYESAMI in Georgia Under Discussion NRx Pharmaceuticals Initiating Phase […]
Every day at NRx we get a variety of questions about our science, business, and other aspects of our work. This CEO Update concerns aviptadil and questions about patents for this peptide. Q: What’s the difference between aviptadil and VIP?A: VIP stands for vasoactive intestinal peptide. It is made in specialized cells like insulin. Aviptadil is […]
We have received questions about the data submitted to the US Food and Drug Administration (FDA) in support of our application for Emergency Use Authorization for ZYESAMI™ to treat patients suffering from Critical COVID-19 with respiratory failure. Since there seems to be some confusion about what the preprint says, I’m going to restate the science. ALL PATIENTS […]
