NRX Pharmaceuticals, Inc. - NRXP STOCK NEWS

NRx Pharmaceuticals announced that the FDA has declined to issue an Emergency Use Authorization for ZYESAMI® (aviptadil) for a subgroup of critically ill COVID-19 patients who were also treated with Remdesivir. This decision follows the previously communicated futility of the ACTIV-3b / TESICO Study. The company will now focus on the development of NRX-101, a treatment for bipolar depression with suicidality. Despite the setback with ZYESAMI®, NRX-101 has received Breakthrough Therapy designation from the FDA, indicating ongoing potential for future development.

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) announced that the FDA denied its request for Breakthrough Therapy designation for ZYESAMI (aviptadil). The decision comes despite positive findings from a post-hoc analysis in patients with Critical COVID-19. The company is now focusing on advancing NRX-101, a BTD compound for Bipolar Depression with suicidal ideation, with topline data expected by year-end. NRx plans to explore ZYESAMI for other indications. The interim CEO expressed disappointment but reaffirmed the commitment to address high unmet patient needs.

NRx Pharmaceuticals (Nasdaq: NRXP) announced the appointment of Seth Van Voorhees, Ph.D., as Chief Financial Officer and Treasurer, effective June 13, 2022. His extensive experience in corporate finance and investment banking aims to enhance the company's focus on its psychiatry franchise, particularly the development of NRX-101, a therapy for severe bipolar depression. The company is advancing clinical trials, including a Phase II trial for bipolar patients with acute suicidal ideation. Interim CEO Robert Besthof thanked former CFO Ira Strassberg for his contributions to internal controls and finance functions.

NRx Pharmaceuticals (Nasdaq: NRXP) announced that the Data Safety and Monitoring Board (DSMB) has recommended halting the ACTIV-3b (TESICO) study evaluating ZYESAMI® (aviptadil) for Critical COVID-19 patients due to futility. Approximately 75% of the 640 patients were reviewed, showing no significant difference in the primary or secondary endpoints compared to placebo. Despite the cessation, no safety concerns were raised, and known side effects were managed. NRx will continue exploring ZYESAMI's potential in other respiratory disorders while focusing on its NRX-101 drug for bipolar depression.

NRx Pharmaceuticals (Nasdaq: NRXP) will provide a corporate update during a webcast on May 24, 2022, at 7:00 a.m. ET, led by interim CEO Robert Besthof and other executives. The presentation will be part of the hybrid H.C. Wainwright & Co. Global Investment Conference. Following the event, a replay will be available on NRx's website for 30 days. The company is known for NRX-101, which targets severe bipolar depression, and ZYESAMI®, currently in a Phase III trial for COVID-19 patients.

NRx Pharmaceuticals (Nasdaq: NRXP) reported its Q1 2022 financial results, highlighting advances in key compounds NRX-101 and ZYESAMI®. The Phase II study of NRX-101 for bipolar depression has commenced, with patient enrollment beginning May 12, 2022. The company has also submitted a new Emergency Use Authorization request for ZYESAMI® to treat Critical COVID-19 patients. Financially, the net loss was $13.4 million, down from $25.5 million a year prior, indicating improvement. Cash reserves increased to $40.2 million, sufficient to support operations for at least 12 months.

NRx Pharmaceuticals has enrolled its first patient in a psychiatry study focusing on bipolar depression with sub-acute suicidality. This trial is part of the development of NRX-101, a patented combination of D-cycloserine and lurasidone, both approved and non-abusive drugs. Notably, 50% of individuals with bipolar disorder experience suicidal ideation or attempts. A Phase IIb/III registrational trial for acute suicidal ideation in bipolar patients is planned for later this year, leveraging Breakthrough Therapy Designation from the FDA based on positive prior data.

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, will report its first quarter 2022 financial results on May 16, 2022, before the market opens. The company will host a conference call at 8:30 AM ET to discuss these results along with clinical and corporate updates. Investors can participate by submitting questions via email by 4:00 PM ET on May 13, 2022. The company is advancing treatments for COVID-19 and severe bipolar depression, with investigational products ZYESAMI® and NRX-101 receiving FDA designations.

NRx Pharmaceuticals has submitted a new Breakthrough Therapy designation request to the FDA for ZYESAMI® (aviptadil) targeting patients with Critical COVID-19 who were also treated with remdesivir. The submission includes safety data from about 750 patients and demonstrates a four-fold increase in survival odds compared to placebo at 60 days. This request follows the FDA's earlier feedback for additional clinical evidence regarding aviptadil's efficacy. The company emphasizes that there are no new adverse drug reactions reported, reinforcing ZYESAMI®'s safety profile in critical care settings.