NRx Pharmaceuticals, Inc. - NRXP STOCK NEWS

NRx Pharmaceuticals (NASDAQ: NRXP) announced plans to file two New Drug Applications (NDAs) in 2024. The first NDA for NRX-101 targets bipolar depression with akathisia, leveraging two positive trials and a Breakthrough Therapy Designation. The second NDA for NRX-100 (IV ketamine) addresses suicidal depression, backed by four positive trials and a Fast Track Designation. Both drugs could potentially generate significant revenue by 2025, with projected figures exceeding $150 per NRXP share. The company aims to complete the necessary 12-month stability data for both applications in 2024. Additionally, NRx is progressing towards the public listing of HOPE Therapeutics, pending completion of a public audit and SEC Form 10 review.

NRx Pharmaceuticals (Nasdaq: NRXP), a clinical stage pharmaceutical company, announced its participation in the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference on June 27, 2024.

Dr. Jonathan Javitt, Chairman and Chief Scientist, will engage in a fireside chat at 7:00am ET. The event can be accessed via a provided link or the Company's Investor Relations website. Additionally, Dr. Javitt and Matthew Duffy, Chief Business Officer, will conduct one-on-one meetings with investors throughout the day.

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced the appointment of Dr. Dennis McBride to its Board of Directors on June 18, 2024. Dr. McBride brings vast experience in Neuroscience, Medical Technology, and Information Technology. His background includes leadership roles in several prominent national labs and founding initiatives that have become multi-billion-dollar enterprises. Dr. McBride has also developed military-proven digital therapeutic technology for stress and depression reduction. This appointment is expected to leverage his expertise to advance NRx's CNS product pipeline and digital therapeutics initiatives.

NRx Pharmaceuticals (Nasdaq: NRXP) has published a Shareholder Update Letter focusing on the company's activities at the American Society of Clinical Psychopharmacology (ASCP) meeting. Key points include the emerging use of intravenous and intranasal ketamine for severe depression and suicidality. NRx's ketamine formulation (NRX-100) has reached the 9-month stability milestone, and three manufacturing lots have been initiated. Short-term nonclinical safety data for NRX-100 has been published and submitted to the FDA. The company anticipates filing a New Drug Application (NDA) for NRX-100 in 2024. Additionally, the FDA advisory panel's recent vote against MDMA has redirected attention to ketamine, already approved as a Schedule 3 drug. NRx plans to market NRX-100 as a single-dose, preservative-free medication to address issues with current multidose vial presentations.

NRx Pharmaceuticals announced the presentation of its Phase 2b/3 trial results for NRX-101 at the ASCP Annual Meeting. The study, titled 'A Randomized, Double-Blind Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to Lurasidone for Adults with Bipolar Depression and Subacute Suicidal Ideation or Behavior,' showed that NRX-101 demonstrated significant benefits over lurasidone. NRX-101 achieved a 58% reduction in the time to sustained remission from suicidality and a 76% reduction in symptoms of akathisia. No treatment-related serious adverse events were reported. The trial results suggest potential for NRX-101 as a new standard of care for bipolar depression, affecting millions globally.

NRx Pharmaceuticals (Nasdaq: NRXP) reported its Q1 2024 financial results and provided a business update. Key highlights include positive clinical data from the Phase 2b/3 trial of NRX-101 for Treatment Resistant Bipolar Depression, showing significant reduction in akathisia. The company plans to file two NDAs this year, including one for NRX-101. A $7.5 million note was executed with an institutional investor, with potential funding up to $30 million. Hope Therapeutics, a new venture, aims to address the national ketamine shortage and will be spun out as a separate entity. Financially, NRx reduced its net loss by 41% year-over-year and decreased R&D expenses by 54%. The company ended Q1 with $1.3 million in cash and improved access to working capital by $8 million. NRx also announced partnership developments and regulatory designations for NRX-101 in treating cUTI and advanced its schizophrenia drug pipeline.

NRx Pharmaceuticals, Inc. (NRx Pharmaceuticals) will participate in the EF Hutton Annual Global Conference on May 15, 2024, in New York City. Prof. Jonathan Javitt, MD, MPH, and Matthew Duffy will meet with investors.

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) will report its first quarter 2024 financial results on May 14, 2024. The Company, a clinical-stage biopharmaceutical firm, will share the results via a press release and host a conference call to discuss them and provide a corporate update.

NRx Pharmaceuticals (NRXP) has announced final clinical trial results showing a superior safety profile of NRX-101 compared to Lurasidone in treating suicidal bipolar depression. NRX-101 demonstrated a 76% reduction in akathisia symptoms with essentially zero levels at day 42, while also seeking accelerated FDA approval for use in patients at risk of akathisia. The study will be presented at the ASCP meeting in May 2024.