Nrx Pharmaceuticals Inc - NRXP STOCK NEWS

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.

NRx Pharmaceuticals (Nasdaq: NRXP) announced Emergency Use Authorization for its drug ZYESAMI™ (aviptadil) in Georgia for treating Critical COVID-19. Following the spike in COVID-19 cases due to the delta variant, the approval allows Georgian doctors access to this treatment. Lead investigators will train local physicians on administering ZYESAMI™. The first doses will arrive within 24 hours, aimed at alleviating the growing healthcare crisis in the nation. ZYESAMI™ targets inflammatory responses linked to COVID-19, addressing a critical need in the current pandemic environment.

NRx Pharmaceuticals (Nasdaq: NRXP) announced the validation of the first commercial formulation of ZYESAMI™ (aviptadil) for intravenous use, enabling high-volume manufacture with over one year of stability. The company has achieved a 30-to-50-fold increase in aviptadil lot size and a 90% reduction in peptide supply costs. These advancements position NRx to potentially deliver millions of doses as they seek Emergency Use Authorization in various regions amidst ongoing COVID-19 challenges.

NRx Pharmaceuticals (Nasdaq: NRXP) will present findings on ZYESAMI™ (aviptadil) at the Disease Control and Prevention Summit on July 21, 2021. The results from a phase 2b/3 trial demonstrate ZYESAMI™ significantly prevents cytokine storms, which are linked to COVID-19 mortality. In contrast to placebo, patients treated with ZYESAMI™ showed a minimal rise in interleukin 6 levels and a significant drop in 60-day mortality rates. The company is seeking Emergency Use Authorization from the FDA based on these findings.