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 (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.
NRx Pharmaceuticals (Nasdaq: NRXP) reported positive outcomes from the Expanded Access Protocol (EAP) for ZYESAMI™ (Aviptadil) on June 15, 2021. Among 240 patients treated, 53% were alive or discharged at 28 days, with 76% of those on high-flow nasal cannula (HFNC) compared to 54% on mechanical ventilation. This data supports the drug’s efficacy in critically ill COVID-19 patients, as many participants were ineligible for the standard trial. Adverse events included diarrhea and hypotension, consistent with earlier phase trials. NRx is advancing ZYESAMI™ to gain regulatory approval.
NRx Pharmaceuticals (Nasdaq: NRXP) has applied for Emergency Use Authorization (EUA) from the FDA for its drug, ZYESAMI™ (Aviptadil-acetate), aimed at treating critically ill COVID-19 patients with respiratory failure.
The study revealed a significant improvement in patient survival and reduced hospital stays compared to a placebo. Enrolled were 196 participants, and the findings support ZYESAMI™ as the first medication showing effectiveness for patients in advanced stages of COVID-19. The clinical trial had positive implications for patient recovery despite prior treatments.
NRx Pharmaceuticals (Nasdaq: NRXP) has announced the election of H.R. McMaster, retired Lieutenant General and former National Security Advisor, to its Board of Directors, effective May 27, 2021. McMaster's extensive military background and his current roles at Stanford University position him to contribute to NRx’s mission of accelerating therapies for patients with critical illnesses. The company also plans to seek Emergency Use Authorization for treatments related to Covid-19 and is advancing NRX-101 for suicidal bipolar depression, currently in Phase 3 trials.
NRx Pharmaceuticals (Nasdaq: NRXP) has signed a master services agreement with Cromos Pharma to conduct phase 3 clinical trials for COVID-19 treatments in Central Europe and the Caucasus Region. This initiative targets a population of over 500 million, many of whom lack access to effective treatments. Aimed at reducing hospitalization rates, NRx plans to complete trials for its inhaled drug, ZYESAMI™, by September 2021. The collaboration involves significant regional healthcare authorities and aims to address critical healthcare needs following discussions with government officials.
On May 25, 2021, NeuroRx announced its successful merger with Big Rock Partners Acquisition Corp., resulting in the formation of NRx Pharmaceuticals, Inc. The new entity will trade on the Nasdaq under the symbol NRXP. The company plans to use the public capital to advance the development of two investigational drugs: ZYESAMI™ for COVID-19 related respiratory failure and NRX-101 for suicidal bipolar depression. Both drugs are currently in FDA-approved Phase 3 trials. NRx aims to seek Emergency Use Authorization for ZYESAMI™ in May 2021.