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).
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. […]
As reported last night in the Times of Israel, the former Director of the Israel Institute for Biological Research (IIBR) disclosed that the BriLife™ Vaccine has shown initial signs of effectiveness against the Omicron variant. This is the information that caused NRx to advise the public that we are moving towards a vanguard trial of […]
At this week’s 2022 H.C. Wainwright BioConnect Virtual Conference, NRx identified the plans to move forward with a vanguard trial of the BriLife investigational vaccine for COVID-19 as a heterologous booster for those already vaccinated with mRNA vaccines.
Yesterday, the Israel Institute for Biological Research (IIBR) announced that it is currently studying the new Omicron variant of the SARS-CoV-2 to assess the extent to which this variant is neutralized by antibodies produced by the BriLife™ COVID-19 vaccine.
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 […]
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. […]
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 […]
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 […]
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 […]