Aviptadil Archives - NRX Pharmaceuticals

Nov. 29, 2021

NRx Pharmaceuticals Identifies Significantly Higher Likelihood of Surviving and Recovering from Critical COVID-19 in ZYESAMI® (aviptadil) Treated Patients Previously Administered Remdesivir

Analysis was conducted in the subgroup of ZYESAMI- and placebo-treated patients who were previously treated with remdesivir in the COVID-AIV trial representing approximately 70 percent of the study population Analysis was conducted in response to US Food and Drug Administration (FDA) request for additional clinical data on effect of ZYESAMI compared to currently-approved therapy including […]

Nov. 22, 2021

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 […]

NRx Pharmaceuticals Reports Third-Quarter 2021 Business Update and Financial Results

RADNOR, Pa., Nov. 16, 2021 (GLOBE NEWSWIRE) — NRx Pharmaceuticals (Nasdaq: NRXP) (NRx), a clinical-stage, biopharmaceutical company, today provided a business update and financial results for the quarter ended September 30, 2021. NRx will host a conference call Tuesday morning, November 16th, at 8:30 AM Eastern Time to discuss its business update and third-quarter financial […]

Nov. 12, 2021

NRx Pharmaceutical’s Chairman and Chief Executive Officer Jonathan Javitt to Present Company Business Update at H.C. Wainwright 7th Annual Israel Conference

Conference Begins on November 15, 2021 RADNOR, Pa., Nov. 12, 2021 (GLOBE NEWSWIRE) — NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage, biopharmaceutical company, today announced its Chairman of the Board and Chief Executive Officer, Jonathan Javitt, will be presenting updates to the Company’s business at the H.C. Wainwright 7th Annual Israel Virtual Conference. Details of the presentation can […]

Nov. 11, 2021

NRx Pharmaceuticals Receives US Food and Drug Administration Review of ZYESAMI® (aviptadil) Manufacturing Information

US Food and Drug Administration Review Allows for High Volume Production of ZYESAMI® (aviptadil) Shelf Life of ZYESAMI Now Extended from 62 Days to 150 Days RADNOR, Pa., Nov. 11, 2021 (GLOBE NEWSWIRE) — NRx Pharmaceuticals (NASDAQ: NRXP), today announced receipt of the US Food and Drug Administration’s (FDA) response to NRx’s October 8 submission of […]

Nov. 8, 2021

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. […]

Nov. 2, 2021

NRx Pharmaceuticals Announces Favorable, New Safety Report for ZYESAMI® (aviptadil) in NIH Sponsored ACTIV-3b Critical Care Study in Patients with Life-Threatening COVID-19

After Review of More than 300 Enrolled Patients in ACTIV-3b Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board; Study Cleared to Continue Enrollment to Target 640 Patients ACTIV-3b Critical Care Study is Evaluating ZYESAMI® (aviptadil) and Remdesivir, in Critical COVID-19 Patients, as Monotherapy and in Combination Against Placebo ACTIV-3b […]

Oct. 25, 2021

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 […]

Oct. 25, 2021

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 […]