NRx Pharmaceuticals Receives FDA Guidance on New Drug Application Path for NRX-100

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) completed an in-person Type C guidance meeting at the headquarters of the US Food and Drug Administration on February 17, 2026. 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.

Based on oral guidance received at the meeting, NRx believes it has a path to filing an application for New Drug Approval of NRX-100 (preservative-free ketamine) based on Substantial Evidence of Effectiveness derived from existing data from adequate and well controlled trials together with confirmatory evidence from more than 65,000 patients identified in the Real World Evidence dataset. NRx will additionally seek a broader indication to serve patients with treatment resistant depression in the context of suicidality, rather than only the subset of patients with suicidality.

The Companies will work collaboratively with the FDA in the coming weeks to finalize the statistical analysis protocol for the full 65,000 person Real World Evidence dataset under FDA's newly published guidance.

In preliminary comments ahead of meeting, FDA advised NRx 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 compared to the currently-approved preservative-containing formulation of ketamine.

The company founder, Chairman, and CEO stated the guidance received will enable use of clinical trial data already in hand together with the proposed Real World Data from Osmind, Inc., to apply for approval of a lifesaving drug to meet the needs of Americans, including Veterans and First Responders. Additional details will be provided upon receipt of the final meeting minutes.

NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101 (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner's National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression.