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 […]
ZYESAMI™
Recently, we’ve received several questions about the Breakthrough Therapy Designation (BTD) application NRx submitted to the US Food and Drug Administration (FDA) for ZYESAMI™ (aviptadil) last month. As you know, we received BTD for our psychiatry drug NRX-101 for suicidal bipolar depression. Admission to the BTD program provided us with increased access to review guidance […]
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. […]
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 […]
NRx is pleased to announce that last week 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 […]
To Our Shareholders, We have received many inquiries from shareholders following the recent encouraging news regarding Merck’s Molnupiravir results in early COVID-19. We have also received various questions about the status of our application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for ZYESAMI. Needless to say, we are […]
After Review of 232 Enrolled Patients in ACTIV-3b Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board ACTIV-3b Critical Care Study is Evaluating ZYESAMI™ and Remdesivir, in Critical COVID-19 Patients, as Monotherapy and in Combination Against Placebo Study Cleared to Continue Enrollment to Target More than 600 Patients ACTIV-3b Critical […]
ZYESAMI™ (aviptadil) Has Previously Demonstrated a Statistically Significant Increase in Survival of Highly Comorbid COVID-19 Patients in Two 60-day Trials In a Study of Highly Comorbid Patients, ZYESAMI Provided a Threefold, Statistically Significant Increase in Likelihood of Survival at One Year RADNOR, Pa., Sept. 27, 2021 /PRNewswire/ — NRx Pharmaceuticals (Nasdaq: NRXP), a clinical stage, biopharmaceutical […]
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 […]