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Updates from the CEO

CEO Update: Report on BriLife’s® Serologic Response to Omicron

NRx is excited about the most recent report published by the Israeli Institute of Biological Research on the BriLife® vaccine. The scientific report shows serologic response against the Omicron variant in patients vaccinated during the phase 2 clinical trial of BriLife® against Sars-CoV-2 coronavirus. Ten of 13 vaccinated subjects demonstrated detectable neutralizing antibody against Omicron. […]

CEO Update: Denial of Breakthrough Therapy Designation

The US Food and Drug Administration (FDA) denied NRx Pharmaceuticals’ (NRx) request for Breakthrough Therapy Designation (BTD) for ZYESAMI® (aviptadil). BTD is not required for drug approval or emergency use authorization, but can afford faster review times, the ability to submit a rolling application, and dedicated FDA review personnel who may interact more frequently with […]

CEO Update: ZYESAMI® (aviptadil) Next Steps

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. […]

CEO Update: Nation of Georgia Emergency Use Authorization

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 […]

CEO Update: Breakthrough Therapy Designation

Recently, we’ve received several questions about the Breakthrough Therapy Designation (BTD) application NRx submitted to the US Food and Drug Administration (FDA) for ZYESAMI™ (aviptadil) last month. As you know, we received BTD for our psychiatry drug NRX-101 for suicidal bipolar depression. Admission to the BTD program provided us with increased access to review guidance […]

CEO Update: Update on ZYESAMI™ (aviptadil) Manufacturing Efforts

NRx is pleased to announce that last week a revised Investigational New Drug module on the manufacturing of ZYESAMI™ (aviptadil) was submitted to the US Food and Drug Administration (FDA), containing documentation that confirmed Nephron Pharmaceuticals, Inc. is prepared to supply ZYESAMI on a commercial scale. This module will now be used as part of […]