NRX Pharmaceuticals, Inc. - NRXP STOCK NEWS

NRx Pharmaceuticals (NRXP) reported that participants in the high-dose BriLife vaccine trial for COVID-19 have been informed they do not require a booster dose, as their immunity remains robust six months post-second dose. In contrast, those who received lower doses are advised to get a booster from Pfizer or Moderna. CEO Prof. Jonathan Javitt indicated preparations for a Phase 2b/3 protocol submission for BriLife are underway. The vaccine is a self-propagating, live-virus variant designed to adapt against evolving COVID-19 strains.

NRx Pharmaceuticals (NRXP) announced a definitive agreement for a private placement to raise approximately $30 million by selling 2,727,273 shares at $11.00 each, along with associated investment options. The offering, managed by H.C. Wainwright & Co., is expected to close by August 23, 2021. Proceeds will support the development of the CNS/psychiatry and COVID vaccine franchises, and transition of ZYESAMI to commercial stages as regulatory approval progresses. The offering is not registered under the Securities Act, limiting its sale in the U.S.

NRx Pharmaceuticals (NRXP) announced a safety update for ZYESAMI™ (aviptadil), confirming no new safety concerns during the NIH-sponsored ACTIV-3 Critical Care Phase 3 study. The Data Safety Monitoring Board reviewed data from approximately 140 patients and recommended continued enrollment. ZYESAMI™ is being tested alongside remdesivir in hospitalized COVID-19 patients requiring high-flow oxygen. This study is one of three ongoing trials for ZYESAMI™ in critical COVID-19 cases. NRx holds FDA Fast Track designation and Breakthrough Therapy Designation for ZYESAMI™.

NRx Pharmaceuticals (Nasdaq: NRXP) reported its second-quarter 2021 results, marking its first quarterly update as a public company. The company submitted an EUA request for its COVID-19 treatment ZYESAMI on May 31 and expects initial orders from Georgia soon. NRx also announced a partnership with the Israeli Institute for Biological Research for the BriLife COVID vaccine. Financially, NRx reported a net loss of $16 million, primarily due to increased R&D and G&A expenses, and had cash reserves of $13.4 million as of June 30, 2021. The next conference call is set for August 17, 2021.

NRx Pharmaceuticals (NASDAQ: NRXP) will announce its second quarter 2021 financial results on August 16, 2021, after market close. A conference call is scheduled for August 17, 2021, at 8:30 AM ET, where management will discuss results and provide updates. Investors can join via phone or a live audio webcast. NRx focuses on developing therapies for serious conditions, including COVID-19 treatment ZYESAMI, which has received FDA Fast Track Designation and is in phase 3 trials. They are also developing NRX-101 for bipolar depression, with readouts expected in 2022.

NRx Pharmaceuticals (NRXP) announced it will ring the Nasdaq Closing Bell on August 10, 2021, marking its listing celebration. CEO Jonathan Javitt highlighted the occasion alongside their recent grant of Emergency Use for ZYESAMI™ for COVID-19 and initiation of international vaccine trials. The FDA granted Fast Track Designation for ZYESAMI™ with ongoing Phase 2b/3 trials. Additionally, NRx secured worldwide rights to develop the BriLife™ COVID vaccine and is progressing with NRX-101 for bipolar depression, which also holds Breakthrough Therapy Designation.

NRx Pharmaceuticals (NRXP) has commenced a phase 2b dose-confirmatory trial of its BriLife™ COVID-19 vaccine in Georgia. The trial aims to validate the vaccine's immune response against the Delta variant before progressing to phase 3 trials globally. Unlike traditional vaccines, BriLife™ is a self-propagating, live-virus vaccine that can be updated for new variants. This initiative follows the Israeli government's grant of exclusive rights to develop and market the vaccine. The trials also coincide with ongoing phase 2 efforts in Israel, focusing on broadening the statistical sample.

NRx Pharmaceuticals has partnered with MannKind Corporation to develop a dry powder formulation of ZYESAMI™ (aviptadil) for respiratory conditions. Utilizing MannKind's Technosphere® platform, the collaboration aims to create an inhalable delivery system that enhances patient convenience. ZYESAMI™ has shown promising results in clinical trials for COVID-19 patients. NRx has received Fast Track Designation from the FDA and is conducting phase 3 trials for both intravenous and inhaled formulations, funded by the NIH and BARDA.

MannKind Corporation (Nasdaq: MNKD) has partnered with NRx Pharmaceuticals (Nasdaq: NRXP) to explore a dry powder formulation of ZYESAMI (aviptadil), aimed at treating respiratory failure due to COVID-19. Currently, ZYESAMI's intravenous formulation is in clinical trials with FDA Fast Track Designation. MannKind's CEO emphasized the potential of their Technosphere technology for delivering treatments effectively. The research is set to occur at MannKind's Danbury facility, which has significant production capabilities.