NRx Pharmaceuticals Receives FDA Support for NRX-100 New Drug Application

NRx Pharmaceuticals has received confirmatory minutes from an in-person Type C guidance meeting at the headquarters of the US Food and Drug Administration. The meeting was attended by leaders of the FDA Division of Psychiatry Products, the FDA Office of Neuroscience, and the FDA Center for Drug Evaluation and Research. The minutes support FDA's willingness to review NRx's application for New Drug Approval of NRX-100 based on Substantial Evidence of Effectiveness derived from existing adequate and well controlled trials. No additional clinical trials were requested. NRx agreed with FDA to submit existing patient-level data for review. In the trials discussed with FDA, ketamine has demonstrated dramatic superiority to placebo and to active placebo, together with non-inferiority versus electroshock therapy. Moreover, ketamine has demonstrated statistically significant reduction in suicidal ideation. Notably, electroshock therapy, the only currently-approved treatment for suicidal ideation demonstrated a 30% incidence of memory loss, whereas ketamine did not. The FDA minutes additionally confirm FDA's willingness to review Real World Evidence as confirmatory evidence of efficacy. Preliminary analysis of that Real World Evidence confirms the effectiveness of intravenous ketamine both in reducing depression and suicidal ideation. Based on the meeting minutes, NRx will seek a primary indication to treat depression in patients with severe depression who may have suicidal ideation, in place of the Company's original plan to treat only those with suicidal ideation. According to the CDC, more than 16 million Americans experience depression each year and 3.6 million Americans contemplate suicide. FDA confirmed in the minutes that no additional nonclinical data would be required for review of NRx's New Drug Application and that no bridging studies would be needed to support NRx's preservative-free formulation, for which the Company anticipates at least three years of room temperature shelf stability. In addition to the pending New Drug Application for NRX-100 based on treatment of depression, NRx has a pending Abbreviated New Drug Application for the sale of preservative-free ketamine under its current label for use in anesthesia. As previously announced, FDA agreed to receive that application in September 2025 and assigned a Summer 2026 decision date.