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Aviptadil

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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NRx Press Release
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 […]

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CEO Update
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 […]

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NRx Press Release
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 […]

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NRx Press Release
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 […]

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