ZYESAMI®

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 […]

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 /PRNewswire/ — 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 results. […]

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 […]

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 […]

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. […]

US Food and Drug Administration Declines Emergency Use Authorization for ZYESAMI® (aviptadil) for Patients with Critical COVID-19 with Respiratory Failure

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, […]