NRx Advancing Investigational Medicines for Critical COVID-19 and Other Respiratory Conditions, Vaccine to Prevent COVID-19 and Breakthrough Drug for Suicidal Depression and PTSD
RADNOR, Pa., Aug. 10, 2021 /PRNewswire/ — NRx Pharmaceuticals (NRx) (Nasdaq: NRXP), a clinical stage, global biopharmaceutical company today announced that the NRx Team, together with Prof Jonathan Javitt, Founder, Chairman and CEO of NRx, will ring the Nasdaq Closing Bell on Tuesday, August 10, 2021 in celebration of NRx’s listing on the Nasdaq Exchange. The ceremony will begin at approximately 3:45 PM ET and can be viewed live at https://www.nasdaq.com/marketsite/bell-ringing-ceremony.
“As we celebrate our first grant of Emergency Use of ZYESAMI™ for COVID-19 overseas and as we initiate international trials for a novel COVID-19 vaccine, we are honored to ring the Nasdaq closing bell,” said Prof Jonathan Javitt, MD, MPH Chairman and CEO of NRx. “Our team has gathered from around the nation to support our credo “Bringing Hope to Life.” As the pandemic continues to devastate families and communities around the world, we strive to advance therapies that aim to get patients with COVID-19 back home to their families and to develop a uniquely promising vaccine that may yield improved immunity against the variants that challenge our way of life.”
The US Food and Drug Administration (FDA) granted Fast Track Designation to NRx for Intravenous ZYESAMI™ (aviptadil) for the treatment of Critical COVID-19 with respiratory failure. NRx has submitted data from a Phase 2b/3 trial of intravenous ZYESAMI™ to the FDA in support of Emergency Use Authorization in the U.S. Ongoing trials, sponsored by the US National Institutes of Health aim to compare ZYESAMI to Veklury from Gilead Sciences (Nasdaq: GILD).
NRx has also been granted exclusive worldwide development and marketing rights to the BriLife™COVIDvaccine developed by the Israel Institute for Biological Research (IIBR). Yesterday, NRx and the Government of Israel announced initiation of phase 2b/3 clinical trials in the Caucasus region in partnership with the Senator Richard Lugar Institute for Biological Research.
In addition to COVID and respiratory focused therapies and vaccines, NRx remains focused on its patented drug, NRX-101 for Suicidal Depression and PTSD. The FDA has awarded Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022.
About NRx Pharmaceuticals
NRx Pharmaceuticals (www.nrxpharma.com) (NRx) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. In July 2021, the Government of Israel awarded NRx the exclusive worldwide right to develop and market the BriLife™ COVID vaccine developed by the Israel Institute for Biological Research.
NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.
Cautionary Note Regarding Forward-Looking Statements
This announcement of NRx Pharmaceuticals, Inc. includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company’s strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company’s management.
The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.
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SOURCE NRx Pharmaceuticals