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Remdesivir

NRx Press Release
Apr. 21, 2022
NRx Pharmaceuticals Files New Breakthrough Therapy Designation Request for ZYESAMI® (aviptadil) in Subgroup of Patients with Critical COVID-19 with Respiratory Failure that were also treated with Remdesivir and continued to progress

NRx Pharmaceuticals, Inc. today announced that it has filed a new Breakthrough Therapy designation request with the U.S. Food and Drug Administration (FDA) focused on a subgroup of patients with Critical COVID-19 that in addition to aviptadil or placebo were also treated with remdesivir.  The request includes safety data on approximately 750 patients treated with intravenous ZYESAMI® for Critical COVID-19.

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NRx Press Release
Jan. 5, 2022
NRx Pharmaceuticals Submits Emergency Use Authorization Application to US Food and Drug Administration for ZYESAMI® (aviptadil) to Treat Patients at Immediate Risk of Death from COVID-19 Despite Treatment with Remdesivir and Other Approved Therapies

NRx Pharmaceuticals (Nasdaq: NRXP) announced today that it has submitted an application for Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) for the use of ZYESAMI® (aviptadil) in patients with Critical COVID-19 who are at immediate risk of death from Respiratory Failure despite treatment with approved therapy including Remdesivir and who are ineligible for enrollment into the ongoing ACTIV-3b NIH-sponsored trial.

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NRx Press Release
Dec. 14, 2021
NRx Pharmaceuticals Announces New, Favorable 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 348 Enrolled Patients in ACTIV-3b Critical Care Study, No New Safety Concerns Identified by Independent Data Safety Monitoring Board; Study Cleared to Continue Enrollment to Target 640 Patients First Patient in Brazil Expected to be Included in US National Institutes of Health (NIH) Trial in February 2022 ACTIV-3b Critical Care […]

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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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Aug. 18, 2021
NRx Pharmaceuticals Announces Positive Safety Report for ZYESAMI™ (aviptadil) in NIH Sponsored ACTIV-3 Critical Care Study in Patients with Life-Threatening COVID-19

After Review of Approximately 140 patients in ACTIV-3 Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board, Study to Continue Enrollment to Target More than 600 Patients ACTIV-3 Critical Care is a Public-Private Partnership Sponsored by the US National Institutes of Health to Treat COVID-19 ACTIV-3 Critical Care is Evaluating […]

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Apr. 26, 2021
Dr. Anthony Fauci Confirms ZYESAMI Phase 3 Trial with Remdesivir at Press Briefing by White House COVID-19 Response Team

PR Newswire RADNOR, Pa., April 26, 2021 /PRNewswire/ — Dosing of the first patient in a phase 3 clinical trial of ZYESAMI (aviptadil acetate) was announced by the National Institutes of Health (NIH) last week. The trial, designated as ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 (TESICO) (www.clinicaltrials.gov NCT04843761), will study ZYESAMI to treat severely ill COVID-19 patients. The […]

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