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, small-molecule pharmaceutical company dedicated to developing novel therapeutics for central nervous system disorders and life-threatening pulmonary diseases. The company's flagship products include ZYESAMI (Aviptadil), aimed at treating COVID-related respiratory failure, and NRX-100/101, the first sequential drug regimen specifically designed for bipolar depression in patients with acute suicidal ideation and behavior.
Recently, NRX Pharmaceuticals announced a public offering of its common stock to raise funds for working capital, general corporate purposes, and to repay certain debts. The proceeds will also support the initiation of a national treatment protocol and a safety database.
Among its most notable developments, the company is advancing NRX-101, designated as an FDA Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRX Pharmaceuticals has strategic partnerships with Alvogen and Lotus for the development and marketing of NRX-101.
The company also oversees Hope Therapeutics, focusing on the development and marketing of IV ketamine for the acute treatment of suicidality and depression, leveraging a digital therapeutic-enabled platform to augment clinical benefits.
NRX Pharmaceuticals' robust pipeline includes plans for a New Drug Application for HTX-100 (IV ketamine) based on promising clinical trial results. It has also received Fast Track Designation from the FDA for the development of ketamine as part of its treatment protocol for acute suicidality.
Furthermore, NRX Pharmaceuticals is exploring the use of NRX-101 for chronic pain and complicated UTI, marking its potential to address significant unmet medical needs across various therapeutic areas. The company remains committed to improving patient outcomes and advancing its innovative therapies through rigorous clinical trials and strategic collaborations.
NRx Pharmaceuticals (NRXP) announced a positive safety update for ZYESAMI™ (aviptadil) during its ACTIV-3b critical care study, led by the NIH. The Independent Data Safety Monitoring Board reviewed 231 patients and reported no new safety concerns, recommending continued enrollment. This follows the safety database growing to over 500 patients with no serious adverse events linked to the drug. ZYESAMI™ is being tested in hospitalized patients with acute respiratory failure due to COVID-19, alongside remdesivir. The announcement emphasizes NRx's commitment to advancing COVID-19 treatments.
NRx Pharmaceuticals (Nasdaq: NRXP) reported promising one-year results for ZYESAMI™ treatment in COVID-19 patients with high comorbidity. A trial showed a statistically significant 3-fold increase in survival rates, with 60% alive post-treatment compared to 20% on standard care. Conducted from June to September 2020, the study demonstrates ZYESAMI's potential in critical cases. These findings align with previous data showing improved survival at 60 days. ZYESAMI is currently under FDA review for Emergency Use Authorization.
IQVIA announced a significant collaboration with NRx Pharmaceuticals to support pharmacovigilance and medical information for the potential emergency use authorization (EUA) of ZYESAMI, a treatment for COVID-19 patients. This partnership leverages IQVIA's extensive data and analytics capabilities to enhance compliance and support regulatory actions as the pandemic continues. NRx appreciates IQVIA's global reach, which will assist in delivering critical treatments to patients in need.
NRx Pharmaceuticals (NRXP) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The event will include a virtual on-demand presentation and one-on-one investor meetings, with the presentation available starting September 13 at 7 AM EST. NRx is developing treatments for COVID-19 and bipolar depression, with investigational products ZYESAMI™ and NRX-101 currently in advanced trials. The company leverages extensive experience from executives with backgrounds at major pharmaceutical firms.
NRx Pharmaceuticals (NRXP) has entered a partnership with Cardinal Health to facilitate third-party logistics and distribution for its drug ZYESAMI™ pending potential Emergency Use Authorization (EUA) from the FDA. This agreement is expected to enhance access to ZYESAMI™ for patients with Critical COVID-19, leveraging Cardinal Health's extensive distribution network, which covers over 90% of U.S. hospitals. The deal aims to expedite treatment for COVID-19 patients in critical care, aligning with NRx's ongoing FDA application process for ZYESAMI™.
NRx Pharmaceuticals (Nasdaq: NRXP) has successfully completed a private placement, raising $30 million by selling 2,727,273 shares of common stock at $11.00 each. Investors also received unregistered preferred investment options, exercisable at $12.00 for three years. This funding is intended to advance three late-stage assets, including a Fast Track treatment for severe COVID-19 cases, a vaccine targeting COVID-19 variants, and a therapy for suicidal bipolar depression and PTSD. H.C. Wainwright & Co. served as the exclusive placement agent for the offering.
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.