NRX Pharmaceuticals, Inc. - NRXP STOCK NEWS

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.

NRx Pharmaceuticals (NASDAQ: NRXP) has completed a business mission to Luxembourg, securing a business license and establishing banking relations with BNP Paribas. The initiative focuses on setting up vaccine manufacturing capabilities for the BriLife vaccine, aiming for a production capacity of over 300 million doses annually. The company has contracted with a local firm for tech transfer and scale-up processes, in line with Good Manufacturing Practices. NRx intends to advance the BriLife vaccine in response to COVID-19 variants, with plans to finalize its vaccine development program before the holiday season.

NRx Pharmaceuticals (NASDAQ: NRXP) announced on Nov. 4, 2021, that the FDA declined to grant Emergency Use Authorization (EUA) for its COVID-19 treatment, ZYESAMI (aviptadil). The FDA cited insufficient data regarding the drug's benefits and risks in critically ill patients. NRx plans to submit data from additional patients treated in the NIH ACTIV-3b trial for FDA review. The ongoing trial has enrolled over 300 patients and reported no new safety issues. NRx is pursuing regulatory approval while making ZYESAMI available under Right to Try laws.

NRx Pharmaceuticals (NASDAQ: NRXP) reported positive safety findings for ZYESAMI® (aviptadil) from the NIH-sponsored ACTIV-3b Phase 3 study, with no new safety concerns noted in over 300 patients. The Independent Data Safety Monitoring Board recommended continued enrollment, reinforcing ZYESAMI's safety for Critical COVID-19 patients lacking alternative treatments. As of now, nearly 600 patients have been treated without unexpected serious adverse events. NRx submitted a request for Emergency Use Authorization for ZYESAMI on May 31, 2021, which is still pending.