Welcome to our dedicated page for Nrx Pharmaceuticals news (Ticker: NRXP), a resource for investors and traders seeking the latest updates and insights on Nrx Pharmaceuticals stock.
NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) is a clinical-stage biopharmaceutical company whose news flow centers on its NMDA-based drug pipeline and interventional psychiatry operations. Company announcements frequently highlight progress with NRX-100, a preservative-free intravenous ketamine formulation, and NRX-101, an oral D-cycloserine/lurasidone combination, both aimed at serious central nervous system disorders such as suicidal depression and suicidal bipolar depression.
Investors following NRXP news can expect updates on FDA interactions, including Fast Track and Breakthrough Therapy designations, Abbreviated New Drug Application (ANDA) milestones for preservative-free ketamine, and New Drug Application (NDA) activities. The company also reports on the use of large Real World Evidence datasets to support potential Accelerated Approval pathways for NRX-100 in suicidal ideation associated with depression and bipolar depression.
Another recurring theme in NRx Pharmaceuticals’ news is the expansion of its HOPE Therapeutics subsidiary, which operates interventional psychiatry clinics. Releases describe clinic acquisitions, strategic interests in practices, and deployment of treatments such as ketamine-based therapies, Transcranial Magnetic Stimulation (TMS), Hyperbaric Oxygen Therapy, and digital therapeutics for suicidal depression, PTSD, and related conditions. Updates often cover new treatment protocols that combine TMS with D-cycloserine and other medications.
NRXP news items also include corporate developments such as conference presentations, corporate update calls, financing transactions, and changes in independent registered public accounting firms, as reflected in SEC filings. For investors and observers, the news stream provides ongoing insight into NRx Pharmaceuticals’ clinical progress, regulatory steps, clinic network growth, and capital markets activity related to its focus on Neuroplastic Therapies and suicidal depression.
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.
NRx Pharmaceuticals (Nasdaq: NRXP) announced a Memorandum Of Understanding with the Government of Israel to license worldwide rights for the development and commercialization of the BriLife™ Coronavirus vaccine, developed by the Israel Institute for Biological Research (IIBR). This vaccine, based on a previously FDA-approved platform, promises rapid manufacturing and affordability. NRx plans to deliver doses for the Israeli population and will collaborate with IIBR, which will receive milestone payments. The initiative aims to address challenges posed by Coronavirus mutations and improve global vaccine accessibility.
NRx Pharmaceuticals and Quantum Leap Healthcare Collaborative have commenced treatment of severely ill COVID-19 patients with inhaled ZYESAMI (Aviptadil) in the I-SPY COVID Trial. This Phase 2 trial focuses on assessing multiple agents simultaneously to reduce mortality and mechanical ventilation needs in these patients. Initial results from intravenous ZYESAMI indicate improved 60-day survival rates. The trial also aims to evaluate the potential efficacy of nebulized ZYESAMI, with the support of BARDA and the Department of Defense.
NRx Pharmaceuticals (Nasdaq: NRXP) announced the initiation of clinical training for ICU physicians in Georgia on using intravenous ZYESAMI™ (Aviptadil-acetate) for emergency COVID-19 treatment. Additionally, the ongoing phase 2/3 trial for inhaled ZYESAMI™ will be extended to Georgia and potentially neighboring countries. Clinical drug supplies are expected to ship within two weeks. The partnership is partially funded through Relief Therapeutics. ZYESAMI™ aims to address COVID-19-related respiratory failure by targeting cellular mechanisms affected by the virus.
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