Nrx Pharmaceuticals Inc Stock Price, News & Analysis

NRx Pharmaceuticals, based in Radnor, PA, will announce its second quarter 2022 financial results on August 15, 2022, before market open. A conference call will follow at 8:30 AM ET, offering a corporate and clinical update along with a Q&A session. Investors can submit questions via email by 4:00 PM ET on August 12. The call can be accessed by dialing (844) 826-3033 (U.S.) or (412) 317-5185 (International) and the replay will be available on the company's website afterwards.

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) appointed Stephen Willard as CEO and Board member, succeeding interim CEO Robert Besthof, who returns to his previous roles. Willard, a veteran in biotechnology management, previously led Cellphire Therapeutics and Flamel Technologies. His expertise includes law and finance, and he’s a National Science Board appointee (2018-2024). Under Willard’s leadership, NRx aims to advance NRX-101, a promising treatment for bipolar depression and acute suicidal ideation, with plans for FDA registration trials.

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.