NRX Pharmaceuticals, Inc. - NRXP STOCK NEWS

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.

NRx Pharmaceuticals (Nasdaq: NRXP) announced enhancements to its Expanded Access and Right to Try programs for ZYESAMI® (aviptadil), aimed at providing treatment for COVID-19 patients with respiratory failure who have not responded to other therapies. As manufacturing capacity increases via Nephron Pharmaceuticals, ZYESAMI will be more widely available to hospitals under FDA guidelines. The NIH is conducting the Phase 3 ACTIV-3b trial, with participants showing improved recovery odds. ZYESAMI is not FDA-approved but remains a critical option amid current healthcare challenges.

NRx Pharmaceuticals (NRXP) has responded to allegations by Relief Therapeutics concerning false statements and failure to provide financial records. NRx asserts that it has not accused Relief's management of criminal behavior, clarifying misunderstandings around previous statements. Asserting compliance, NRx indicates that it provided over 1,000 pages of financial documents before the mediation date. NRx anticipates mediation on February 22, 2022, to address claims of breach of contract by Relief, arguing that the latter's accusations are attempts to distract from its obligations under their collaboration agreement.

NRx Pharmaceuticals (NASDAQ: NRXP) announced advancements in the investigation of its BriLife™ COVID-19 vaccine, with plans for a phase 2b/3 study targeting COVID-19 variants, including Omicron. The company is collaborating with the U.S. Health and Human Services and several European governments. A trial using the NanoPass MicronJet™ system for intradermal delivery of the vaccine is approved in Israel, which may enhance immune response. NRx continues scaling up for commercial manufacturing anticipated by Q4 2022.

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.