NeuroRx, Inc., an Israeli medical company, was approved by the Nasdaq for listing on the Nasdaq Global Market, following the completion of its business combination with Big Rock Partners Acquisition Corp. (Nasdaq:BRPA). The combined entity is called NRx Pharmaceuticals, Inc. and will trade on the Nasdaq Global Market as NRXP. The IPO was handled as an SPAC merger.
The news comes at the same time that the company revealed that it had received authorization to conduct phase 3 clinical trials of COVID-19 related drugs and vaccines in Central Europe and the Caucasus Region. This region comprises a population of more than 500 million people, many of whom lack access to current COVID-19 vaccines and therapies.
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Investopedia explains that a special purpose acquisition company (SPAC) is a company with no commercial operations that is formed strictly to raise capital through an initial public offering (IPO) for the purpose of acquiring an existing company. Also known as “blank check companies,” SPACs have been around for decades.
Founded in 2015, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) is a patient-focused, clinical-stage pharmaceutical company, drawing upon more than 100 years of collective medicine development experience. NRx creates therapies to treat diseases where no medicines currently exist.
NRx expects to seek Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) to treat Critical Covid-19 in patients suffering respiratory failure in May 2021. In addition, the FDA has granted Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 in suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with data readouts expected in the first half of 2022.
“Today marks a major milestone as we include public investors in our quest to bring innovative medicines to patients at immediate risk of death, who have no currently-approved medicinal therapies. We live by our credo of “Bringing Hope to Life,” said Professor Jonathan Javitt, MD, MPH, Founder, CEO and Chairman of the Board, of NRx. “We are indebted to the leaders and shareholders of BRPA who have chosen to support our mission.”
As a Nasdaq-listed company, NRx will deploy public capital to continue development of two investigational medicines: ZYESAMI™, (Aviptadil acetate) the first FDA Fast Track-designated investigational medicine, being studied in critically-ill patients with COVID-19 induced respiratory failure, and NRX-101 (a combination drug therapy of D-cycloserine and lurasidone), the first investigational medicine to receive FDA Breakthrough Therapy Designation for patients with suicidal bipolar depression. ZYESAMI™ has demonstrated a statistically significant increase in the likelihood of survival and recovery from respiratory failure in a phase 2b/3 trial (co-funded with Relief Therapeutics (SIX:RLF, OTCBB:RLFTF) of critically-ill patients with COVID-19.1,2 These advantages were previously reported in an open label trial of critically-ill patients at the Houston Methodist Hospital.3 The company expects to seek Emergency Use Authorization of ZYESAMI™ from the FDA in May 2021.
NRX-101 is based on the inventions and innovation of Prof. Daniel Javitt, MD, PHD, who first explained the impact of the brain’s NMDA receptor in schizophrenia and other psychiatric diseases. NRX-101 has demonstrated a statistically-significant advantage in maintaining remission from depression after initial treatment with ketamine in a phase 2 study.4 Currently, the only FDA-approved treatment for suicidal bipolar depression is electroshock therapy.
