FDA Declines Emergency Use Authorization for ZYESAMI® (aviptadil) for subgroup of Patients with Critical COVID-19 at immediate risk of death from respiratory failure despite treatment with approved therapy, including remdesivir

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NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), (“NRx Pharmaceuticals”), a clinical-stage biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) has declined to issue an Emergency Use Authorization (EUA) for ZYESAMI® (aviptadil) for a sub-group of patients that in addition to ZYESAMI®, also received Remdesivir and continued to progress.  NRx Pharmaceuticals had submitted this last EUA application using data from a post-hoc subgroup analysis.

NRx Pharmaceuticals Under New Leadership with a Renewed Focus on Bipolar Drug Candidate

Published on : Published by : Alex Keown

Following the recent retirement of Jonathan Javitt in March, Robert Besthof, Head of Operations and Chief Commercial Officer, has taken over as interim chief executive officer of NRx Pharmaceuticals. He said there was a need for a CEO to be based in the U.S. alongside the rest of the team.

NRx Pharmaceuticals Announces Data Safety Monitoring Board (DSMB) Update on U.S. National Institutes of Health (NIH) Study of ZYESAMI® (aviptadil) in Critical COVID-19

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NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals”), a clinical-stage biopharmaceutical company, today announced results of a review conducted by the Data Safety and Monitoring Board (DSMB) on May 25, 2022. The DSMB reviewed data of approximately 460 patients with Critical COVID-19 Respiratory Failure who were enrolled in the ACTIV-3b (TESICO) trial, most of which had reached the 90-day endpoint. The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

NRx Pharmaceuticals Announces Leadership Transition

Headshot of NRx CEO Jonathan Javitt
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NRx Pharmaceuticals (Nasdaq: NRXP) (“NRx” or the “Company”), a clinical-stage, biopharmaceutical company, today announced that Jonathan Javitt, MD, MPH, has retired as Chief Executive Officer effective immediately. The Board of Directors appointed Robert Besthof, Head of Operations and Chief Commercial Officer, as Interim CEO.

NRx Aims to Bring Zyesami to Market Based on Real-World Data in Treating Seriously Ill COVID-19 Patients

Published on : Published by : Alex Keown

For Jonathan Javitt, Chief Executive Officer of NRx Pharmaceuticals, the company’s experimental COVID-19 treatment aviptadil, which will be known by the trade named Zyesami, can play a key role in saving the lives of those patients who are seriously ill and have failed to respond to Gilead Sciences’ antiviral drug, Remdesivir.