Key data from the phase 2b/3 trial of ZYESAMI vs. Placebo (COVID-AIV) for treating patients with Respiratory Failure in Critical COVID-19 were presented at the February 2022 Congress on Retroviruses and Opportunistic Infections (CROI).
I recently received the letter below from a shareholder. The correspondence from them (taken exactly from their email) and my response regarding our next steps for ZYESAMI ® (aviptadil) can be found below. Email from R.B., a shareholder of NRx Pharmaceuticals Dear Dr. Javitt I have been heartbroken since the denied emergency approval for Zyesami/Aviptadil. […]
NRx Pharmaceuticals Has Requested a Type A Meeting with US Food and Drug Administration (FDA) to Include Treating Physicians and Patients FDA Commits to Working with NRx to Develop ZYESAMI® ZYESAMI Clinical Trials Funded by the US National Institutes of Health and BARDA Continue and Advance Towards Enrollment in Brazil and Europe RADNOR, Pa., Nov. 4, […]
We have received several questions about the status of the Emergency Use Authorization granted to aviptadil in the Nation of Georgia. Attached please find a copy of the official notification from the Regulation Agency for Medical and Pharmaceutical Activities of the Nation of Georgia, that states as follows: 06 August 2021 Georgian Respiratory Association to […]
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 […]
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 […]
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 […]
NRx has Validated a Formulation, Manufacture, and Container Closure Method Suitable for High Volume Manufacture with Anticipated 1 year or greater stability
Sudden Rise in Inflammatory Cytokines (IL-6) Associated with Death in COVID-19 and Other Forms of Acute Respiratory Distress Syndrome Data from Randomized Phase 2b/3 Trial Shows Patients Treated with ZYESAMI™ are Significantly Less Likely to Experience IL-6 Cytokine Rise, and Have Improved Survival and Recovery from Respiratory Failure, Compared to Patients Receiving Placebo Data Have […]
