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Critical COVID-19

Nov. 4, 2021
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, […]

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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 […]

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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 […]

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Oct. 14, 2021
Journal of Infectious Diseases and Treatment Publishes Positive Trial Data of Aviptadil in High Comorbidity Patients Suffering from Critical COVID-19 with Respiratory Failure

Seventeen of 21 Patients Treated with Aviptadil Survived to Day 60 Compared to 5 of 24 in the Controlled Group of Patients RADNOR, Pa., Oct. 14, 2021 /PRNewswire/ — NRx Pharmaceuticals (Nasdaq: NRXP), today announced the publication of peer-reviewed results from a prospective, open-label, administratively controlled trial of aviptadil for the treatment of respiratory failure in patients with Critical COVID-19. […]

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Oct. 12, 2021
NRx Pharmaceuticals Announces Progress on Worldwide Commercial Scale Development of ZYESAMI™ (aviptadil)

RADNOR, Pa., Oct. 12, 2021 /PRNewswire/ — NRx Pharmaceuticals (Nasdaq: NRXP), today announced that 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 […]

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Sep. 13, 2021
IQVIA and NRx Pharmaceuticals Collaborate on Potential Medical Support for Novel COVID-19 Treatment

September 13, 2021 04:15 PM Eastern Daylight Time RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–IQVIA™ (NYSE:IQV), a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry, today announced a transformative collaboration with NRx Pharmaceuticals (NRx) (Nasdaq: NRXP). NRx is a company dedicated to creating innovative, life-saving treatments and bringing […]

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Sep. 4, 2021
CEO Update: Ongoing Communications with the US Food and Drug Administration

NRx Pharmaceuticals continues to receive many requests for updates on the status of the US Food and Drug Administration’s (FDA) review of NRx’s application for Emergency Use Authorization (EUA) of ZYESAMI™ (aviptadil), to treat patients suffering from Critical COVID-19 with respiratory failure. On September 3, 2021, NRx received a request for additional clinical information from […]

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