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.
Quantum Leap Healthcare Collaborative (QLHC) and NRx Pharmaceuticals announced the cessation of the nebulized ZYESAMI® (Aviptadil) in the I-SPY COVID Trial targeting critically ill COVID-19 patients. The Data Monitoring Committee identified futility, indicating a low probability of recovery improvement compared to standard treatments. Of 118 enrolled patients, results showed no significant clinical benefit from the nebulized form. The intravenous version, however, continues to be assessed in another trial. Future studies may explore alternative dosing methods for ZYESAMI.
NRx Pharmaceuticals (Nasdaq: NRXP) announced it will report its year-end 2021 financial results on March 31, 2022, before the market opens. A conference call and webcast will take place on the same day at 8:30 AM ET, providing a clinical and corporate update. Investors can submit questions via email before 4:00 PM ET on March 29, 2022. The call will be accessible via phone or webcast, with a replay available afterwards on the company's website. NRx specializes in treatments for severe conditions, including COVID-19 and bipolar depression.
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has appointed Ira Strassberg as Chief Financial Officer and Treasurer, effective March 15, 2022. Strassberg brings over 30 years of financial expertise and previously served as Deputy CFO at Cantor Fitzgerald. The interim CEO, Robert Besthof, expressed confidence in Strassberg's contributions to advancing clinical programs for ZYESAMI® and NRX-101. The company is currently running phase 3 trials for both investigational products, supported by various US government entities.
NRx Pharmaceuticals (Nasdaq: NRXP) has announced the retirement of CEO Jonathan Javitt, effective immediately. Robert Besthof, the company's Chief Commercial Officer, is appointed as Interim CEO while the Board searches for a permanent replacement. Besthof brings extensive experience from Pfizer and Eli Lilly, and will focus on advancing NRx's pipeline and strategic initiatives, particularly concerning ZYESAMI® for COVID-19 and the NRX-101 psychiatric portfolio. Javitt will transition to a consulting role as Chief Scientist.
NRx Pharmaceuticals (Nasdaq: NRXP) announced a positive review from the DSMB regarding its ZYESAMI® (aviptadil) treatment for critically ill COVID-19 patients in the Phase 3 ACTIV-3b trial. The trial has enrolled 448 patients, achieving over 80% of its target. No serious adverse events related to ZYESAMI were reported, bolstering its safety profile among more than 800 treated patients. Following the discontinuation of another study arm, ZYESAMI remains the sole investigational drug in the ACTIV-3 trial. NRx plans to provide further updates on its Phase 2b/3 trial findings soon.
NRx Pharmaceuticals (Nasdaq: NRXP) has reported remarks by Dr. Shmuel Yitzhaki of the Israel Institute for Biological Research, indicating their BriLife vaccine may demonstrate superior neutralizing ability against the Omicron variant relative to the Pfizer vaccine. Despite a three-fold decrease in efficacy, it outperforms Pfizer's 8 to 20 fold reduction. The scalable, modular vaccine technology shows potential for adaptability to new variants. NRx has received 173 million shekels in funding for this project, which is carried out by 80 staff members, indicating efficient resource use compared to other firms.
NRx Pharmaceuticals (NRXP) announced the closure of a private placement resulting in $25 million in gross proceeds. The offering included 7,824,727 shares of common stock and investment options exercisable at $3.07 per share. The shares were sold at a price of $3.195 each, a premium over market value. The offering was facilitated by H.C. Wainwright & Co. The company is actively developing treatments for COVID-19 and bipolar depression, with ongoing clinical trials and regulatory designations, including Fast Track and Breakthrough Therapy Designation.
NRx Pharmaceuticals (NRXP) has announced a private placement to sell 7,824,727 shares of common stock at $3.195 each, along with unregistered investment options for the same number of shares at an exercise price of $3.07. The expected gross proceeds are approximately $25 million, set to close around February 2, 2022. The funds will be directed towards advancing their three therapies, including the COVID-19 treatment, ZYESAMI. H.C. Wainwright & Co. acts as the exclusive placement agent for this offering.
NRx Pharmaceuticals (NASDAQ: NRXP) announced that the BriLife® vaccine shows potential effectiveness against the Omicron variant of SARS-CoV-2, according to findings from the Israel Institute for Biological Research (IIBR). The vaccine demonstrated a mean neutralization titer of 53 against Omicron, compared to 152 against the original virus. The IIBR concluded that BriLife®-induced antibodies maintain neutralizing potential against all tested variants. NRx aims to test BriLife as a booster in a phase 2 trial across Israel and other partner countries.
On January 26, 2022, NRx Pharmaceuticals (NRXP) announced a safety report from a Southwestern hospital regarding ZYESAMI® (Aviptadil) treatment for COVID-19 respiratory failure under the Right to Try Law. Of the first 19 patients treated by December 31, 2021, three died, while 16 (84%) were reported alive by January 22, 2021, with 14 discharged. No Serious Adverse Events linked to ZYESAMI were reported. The data will support an FDA Emergency Use Authorization application for critical COVID-19 patients. ZYESAMI is also undergoing trials in the NIH-sponsored ACTIV-3b trial.