Nrx Pharmaceuticals Inc Stock Price, News & Analysis

NRx Pharmaceuticals (NASDAQ: NRXP) announced that its CEO, Prof Jonathan Javitt, will present updates on the BriLife™ COVID-19 vaccine at the H.C. Wainwright BioConnect Virtual Conference on January 10, 2022, at 9 AM EST. The presentation will include new details regarding late-stage trials and effectiveness against the Omicron variant. NRx previously reported early data showing BriLife’s efficacy against the Delta variant. The company collaborates with the Israel Institute for Biological Research to enhance the ongoing trials.

NRx Pharmaceuticals (NASDAQ: NRXP) will present updates on its business at the H.C. Wainwright BioConnect Virtual Conference on January 10, 2022, at 7:00 AM EST. The company is known for developing the BriLife™ vaccine and ZYESAMI® for COVID-19. It has received Fast Track designation from the FDA and is conducting Phase 3 trials for various treatments, including NRX-101 for bipolar depression. The presentation link is available here.

NRx Pharmaceuticals (Nasdaq: NRXP) announced its submission for Emergency Use Authorization (EUA) for ZYESAMI® (aviptadil) to treat Critical COVID-19 patients facing imminent death despite existing therapies. This application follows feedback from a previous EUA request and incorporates new Phase 2b/3 data showing ZYESAMI significantly improves survival odds: 2.8-fold higher at 28 days and 10-fold for patients on ventilators. ZYESAMI is considered an option for patients with no alternatives, aiming to enhance recovery chances amid rising COVID-19 fatalities.

NRx Pharmaceuticals (Nasdaq: NRXP) has filed a provisional patent application with the US Patent and Trademark Office for stable, buffer-free compositions of Vasoactive Intestinal Peptide (VIP), known as aviptadil, aimed at treating COVID-19 and other diseases. This patent addresses stability issues previously encountered with VIP formulations, enhancing its potential for long-term storage and national stockpile inclusion. The FDA has reviewed these innovations concerning ZYESAMI®, expected to offer a pathway for innovative drug protection and potential market launch following safety and efficacy assessments.

NRx Pharmaceuticals (NRXP) announced the filing of a new Breakthrough Therapy Designation request with the FDA for ZYESAMI® (aviptadil) aimed at treating COVID-19 patients facing respiratory failure despite existing therapies. This request follows positive clinical trial results showing a statistically significant increase in survival odds among patients treated with ZYESAMI after Remdesivir failure. The FDA previously declined ZYESAMI's Emergency Use Authorization but invited a new request based on clinical data. NRx aims to help over 100,000 Americans recovering from COVID-19.

NRx Pharmaceuticals (NRXP) has been added to the Nasdaq Biotechnology Index (NBI), effective December 20, 2021. This inclusion is expected to enhance institutional ownership in NRx shares through index fund purchases. The NBI measures the performance of Nasdaq-listed biotechnology and pharmaceutical companies. NRx meets the criteria for this inclusion, including a minimum market capitalization of $200 million. The company is progressing in its COVID-19 treatments and other therapies with ongoing Phase 3 trials.

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.