NRx Pharmaceuticals, Inc. 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, Inc. is pleased to announce that on June 13, 2022, the plaintiffs in the securities class action lawsuit captioned “Dal Bosco v. NRx Pharmaceuticals, Inc. et al.” filed a notice in the U.S. District Court for the District of Delaware voluntarily dismissing the action against NRx Pharmaceuticals and its former officers. The dismissal was made without prejudice.
NRx Pharmaceuticals, Inc. today announced that the FDA denied the Breakthrough Therapy designation (BTD) request for ZYESAMI® (aviptadil) and emphasizes focus on its NRX-101 BTD compound for Bipolar Depression associated with Suicidality.
Key data from the phase 2b/3 trial of ZYESAMI vs. Placebo (COVID-AIV) for treating patients with Respiratory Failure in Critical COVID-19 were presented at the February 2022 Congress on Retroviruses and Opportunistic Infections (CROI).
Source – https://spotonflorida.com/north-central-florida/3555710/lauds-mothers-covid-recovery-after-experimental.html?fbclid=IwAR31nFkp71HPsff_C9YKR84H9KzNpWavAbjlQWJ8FRrlQI8zWNnmnGo0Bb8
NRx Pharmaceuticals is a great speculative biotech to look into. While there are many types of treatments and vaccines for Covid-19, NRX-101 gives the company a chance to get into the bipolar depression space as well. Even then, there is a possible expansion opportunity for ZYESAMI beyond Covid-19.
NRx Pharmaceuticals today announced results of a review conducted by the Therapeutics and Prevention Data Safety and Monitoring Board (DSMB) of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).
NRx Pharmaceuticals has received a first safety report from a Southwestern hospital where physicians have administered ZYESAMI® (Aviptadil) to patients with COVID-19 respiratory failure.
NRx Pharmaceuticals announced enhancements to its Expanded Access and Right to Try programs. The programs enable patients with respiratory failure from COVID-19, who have tried all approved medicines, including remdesivir, and who are not able to participate in a clinical study, to receive ZYESAMI® (aviptadil) upon a physician’s prescription.