Business
NRx Pharmaceuticals (NASDAQ:NRXP) Reports Third Quarter and Year to Date 2024 Financial Results and Provides Business Update
On track to file New Drug Applications (NDAs) for NRX-100 (IV Ketamine) in treating suicidal ideation in depression, including bipolar depression and NRX-101
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"On track to file New Drug Applications (NDAs) for NRX-100 (IV Ketamine) in treating suicidal ideation in depression, including bipolar depression and NRX-101 (Oral D-Cycloserine/Lurasidone) for Accelerated Approval in bipolar depression with suicidality or akathisia by year end 2024 with 2025 PDUFA date forecast.HOPE Therapeutics acquiring Interventional Psychiatry Clinics; key to developing a best-in-class network of care to prevent suicide, continues to expect first revenue by year-end 2024.74% reduction in net operating losses compared to 3rd quarter 2023 with profitability forecast in 2025 from HOPE Therapeutics and from sales of medication.Management to host a conference call November 18, 2024 at 4:30 PM ETWILMINGTON, Del., Nov. 14, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (\"NRx Pharmaceuticals\", the \"Company\"), a clinical-stage biopharmaceutical company, today announced its financial results for the quarter and year to date ended September 30, 2024 and provided a business update. \n \nKey Clinical and Business Activities\nNRX-100 (IV Ketamine) safety and efficacy data have been aggregated from clinical trials in more than 500 patients in collaboration with leading US and French Universities that demonstrate a highly significant reduction in suicidal ideation compared to placebo and active comparator. IV ketamine has been shown to be superior (in post-hoc analysis) to electroshock therapy in treating depression. Stability data has now been generated for three manufacturing lots required for NDA filing in suicidal depression, toxicology data are complete, and alignment with the FDA on its Pediatric Study Plan has been received. If approved, NRX-100 would be the world's first medicine to treat acute suicidality, a condition that kills 1 American every 11 minutes, according to the US Centers for Disease Control.NRX-101 NDA for accelerated approval in bipolar depression with suicidality or akathisia advancing, based on data from the Phase 2b/3 trial in suicidal patients with bipolar depression, which demonstrated depression efficacy comparable to standard of care and significant reduction of akathisia (P=0.025) and time to sustained remission from suicidality (P=.05). These data, along with data from our STABIL-B trial, support a possible best-in-class suicidal bipolar depression medication profile. Thi...