NRX Pharmaceuticals, Inc. - NRXP STOCK NEWS

NRx Pharmaceuticals announced that the Independent Data Safety Monitoring Board found no new safety concerns in the ongoing ACTIV-3b Critical Care Study evaluating ZYESAMI® (aviptadil) for COVID-19 patients. 348 patients have been reviewed, and enrollment will continue toward a target of 640 patients. The NIH expects the first patient from Brazil to be included by February 2022. The study is pivotal in assessing ZYESAMI's safety and effectiveness alongside remdesivir, and it reflects NRx's commitment to treating critical COVID-19 cases.

NRx Pharmaceuticals (NASDAQ: NRXP) has reached high-level agreements with Hungary to facilitate the emergency use of ZYESAMI® (aviptadil) and to initiate a pivotal clinical trial for the BriLife COVID-19 vaccine. Hungary will be the first European country to host a registrational phase 2b/3 trial for BriLife, with regulatory approval expected by the end of 2021. Additionally, a compassionate care program for ZYESAMI is set to commence in Hungary, aligning with U.S. FDA protocols. This partnership aims to address the ongoing COVID-19 crisis in the region.

NRx Pharmaceuticals (NASDAQ: NRXP) announced the completion of a safety review by the Data Safety Monitoring Board for its BriLife phase 2 trial, with a formal report pending. Following this, the company plans to initiate a phase 2b/3 registration trial for BriLife, having received guidance from the European Medicines Agency and the World Health Organization. Over 10 countries have expressed interest in participation. The trial, expected to start in Israel and Georgia, will assess BriLife's effectiveness against the Delta variant and aims to establish a non-inferiority design compared to existing vaccines.

NRx Pharmaceuticals (NRXP) announced a new analysis of its treatment ZYESAMI® (aviptadil) for patients with Critical COVID-19 and Respiratory Failure. This analysis, led by statistician Prof. David Schoenfeld, indicates a statistically significant 2.5-fold increase in the odds of survival at 60 days for patients treated with ZYESAMI compared to placebo. The FDA has requested additional clinical data to support Emergency Use Authorization (EUA) and Breakthrough Therapy Designation (BTD). ZYESAMI's efficacy was specifically noted in patients who did not improve after remdesivir treatment.

NRx Pharmaceuticals (NASDAQ: NRXP) highlighted promising results from the Phase 2 trial of its BriLife® COVID-19 vaccine. An analysis revealed that 10 out of 11 vaccinated patients generated neutralizing antibodies against the Delta variant, comparable to responses against the original virus. This suggests the potential adaptability of BriLife® against evolving variants. NRx plans to initiate a Phase 2b/3 registration trial following a Data Safety Monitoring Board review of the Phase 2 results, underscoring the vaccine's ongoing development amid rising variant challenges.

NRx Pharmaceuticals (Nasdaq: NRXP) provided a business update and Q3 financial results, revealing a net loss of $20.8 million ($0.40 per share), up from $5.2 million ($0.15 per share) in Q3 2020. The company focuses on three Phase 3 investigational products: ZYESAMI for COVID-19 treatment, BriLife vaccine, and NRX-101 for suicidal bipolar depression. NRx has increased its cash reserves to $38.9 million. Manufacturing processes for ZYESAMI have been developed for scalability. The company anticipates launching a new drug application for ZYESAMI while preparing for clinical trials for NRX-101.

NRx Pharmaceuticals (NASDAQ: NRXP) has announced that its CEO, Jonathan Javitt, will present updates on the company’s business during the H.C. Wainwright 7th Annual Israel Virtual Conference on November 15, 2021, at 1:30 PM EST. The presentation can be accessed through a provided link. NRx is known for its investigational product ZYESAMI®, aimed at treating COVID-19 and currently in phase 3 trials supported by various US government bodies. The company is also advancing NRX-101 for treating suicidal bipolar depression, with readouts expected in 2022.

NRx Pharmaceuticals (NRXP) announced a significant FDA review outcome allowing high-volume production of ZYESAMI® (aviptadil). The FDA confirmed no clinical hold on manufacturing, enabling the drug to be produced under Good Manufacturing Practices (GMP) at scales of 10,000 to 100,000 doses. Additionally, the shelf life of ZYESAMI has been extended from 62 to 150 days. This development paves the way for NRx to potentially explore ZYESAMI's application in various severe lung injury conditions beyond COVID-19.

NRx Pharmaceuticals (NRXP) plans to announce its third-quarter 2021 financial results on November 16, 2021, before market opening. A conference call and webcast will follow at 8:30 AM ET to discuss these results and provide updates on clinical and corporate developments. Investors wishing to participate can submit questions via email in advance. The call will also be accessible through a toll-free number and a dedicated webcast link. NRx is focused on significant projects, including ZYESAMI® for COVID-19 and NRX-101 for bipolar depression.