Nrx Pharmaceuticals Inc Stock Price, News & Analysis

NRx Pharmaceuticals (Nasdaq: NRXP) announced peer-reviewed results highlighting the efficacy of aviptadil in treating respiratory failure in Critical COVID-19 cases. The study found a 60-day survival rate of 81% for aviptadil-treated patients, compared to 21% for standard care (P<.0001). Additional benefits included significant improvements in respiratory distress and cytokine levels. Conducted at Houston Methodist Hospital, the trial focused on high-risk patients with comorbidities who had not responded to other treatments. Aviptadil demonstrated rapid respiratory function improvements with no severe drug-related adverse events reported.

On October 12, 2021, NRx Pharmaceuticals (NRXP) announced the submission of a revised Investigational New Drug module to the FDA for ZYESAMI™ (aviptadil), confirming Nephron Pharmaceuticals' capacity for commercial-scale production. This module supports the FDA's rolling review for the New Drug Application of ZYESAMI.

Additionally, an EU QP Auditor completed a successful inspection of a separate manufacturing facility, which is a critical step for ZYESAMI's approval in the EU and UK.

NRx Pharmaceuticals (NRXP) announced a positive safety update for ZYESAMI™ (aviptadil) during its ACTIV-3b critical care study, led by the NIH. The Independent Data Safety Monitoring Board reviewed 231 patients and reported no new safety concerns, recommending continued enrollment. This follows the safety database growing to over 500 patients with no serious adverse events linked to the drug. ZYESAMI™ is being tested in hospitalized patients with acute respiratory failure due to COVID-19, alongside remdesivir. The announcement emphasizes NRx's commitment to advancing COVID-19 treatments.

NRx Pharmaceuticals (Nasdaq: NRXP) reported promising one-year results for ZYESAMI™ treatment in COVID-19 patients with high comorbidity. A trial showed a statistically significant 3-fold increase in survival rates, with 60% alive post-treatment compared to 20% on standard care. Conducted from June to September 2020, the study demonstrates ZYESAMI's potential in critical cases. These findings align with previous data showing improved survival at 60 days. ZYESAMI is currently under FDA review for Emergency Use Authorization.

IQVIA announced a significant collaboration with NRx Pharmaceuticals to support pharmacovigilance and medical information for the potential emergency use authorization (EUA) of ZYESAMI, a treatment for COVID-19 patients. This partnership leverages IQVIA's extensive data and analytics capabilities to enhance compliance and support regulatory actions as the pandemic continues. NRx appreciates IQVIA's global reach, which will assist in delivering critical treatments to patients in need.

NRx Pharmaceuticals (NRXP) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The event will include a virtual on-demand presentation and one-on-one investor meetings, with the presentation available starting September 13 at 7 AM EST. NRx is developing treatments for COVID-19 and bipolar depression, with investigational products ZYESAMI™ and NRX-101 currently in advanced trials. The company leverages extensive experience from executives with backgrounds at major pharmaceutical firms.

NRx Pharmaceuticals (NRXP) has entered a partnership with Cardinal Health to facilitate third-party logistics and distribution for its drug ZYESAMI™ pending potential Emergency Use Authorization (EUA) from the FDA. This agreement is expected to enhance access to ZYESAMI™ for patients with Critical COVID-19, leveraging Cardinal Health's extensive distribution network, which covers over 90% of U.S. hospitals. The deal aims to expedite treatment for COVID-19 patients in critical care, aligning with NRx's ongoing FDA application process for ZYESAMI™.

NRx Pharmaceuticals (Nasdaq: NRXP) has successfully completed a private placement, raising $30 million by selling 2,727,273 shares of common stock at $11.00 each. Investors also received unregistered preferred investment options, exercisable at $12.00 for three years. This funding is intended to advance three late-stage assets, including a Fast Track treatment for severe COVID-19 cases, a vaccine targeting COVID-19 variants, and a therapy for suicidal bipolar depression and PTSD. H.C. Wainwright & Co. served as the exclusive placement agent for the offering.

NRx Pharmaceuticals (NRXP) reported that participants in the high-dose BriLife vaccine trial for COVID-19 have been informed they do not require a booster dose, as their immunity remains robust six months post-second dose. In contrast, those who received lower doses are advised to get a booster from Pfizer or Moderna. CEO Prof. Jonathan Javitt indicated preparations for a Phase 2b/3 protocol submission for BriLife are underway. The vaccine is a self-propagating, live-virus variant designed to adapt against evolving COVID-19 strains.