NRx Pharmaceuticals Charts Path to NDA for NRX-100 Following FDA Guidance

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) announced on February 17, 2026, that it has completed an in-person Type C guidance meeting with the U.S. FDA, receiving oral feedback that outlines a path to filing a New Drug Application for NRX-100 (preservative-free ketamine). 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 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. The meeting was attended by NRx together with partner Osmind, and included input from the FDA's Center for Drug Evaluation and Research (CDER), as well as the Office of Surveillance and Epidemiology.

The FDA indicated that existing clinical trial data, combined with Real World Evidence from more than 65,000 patients, could provide Substantial Evidence of Effectiveness under the drug's Fast Track Designation. The FDA indicated that the proposed clinical endpoints may be acceptable for full approval. This represents a shift from the previously anticipated accelerated approval route.

Based on this guidance, NRx plans to seek a broader indication for NRX-100 to serve patients with treatment-resistant depression in the context of suicidality, rather than limiting the application to those with suicidality alone or only the subset of patients with suicidality. The company anticipates submitting the NDA in the second quarter of 2026 with a potential PDUFA decision later that year.

In preliminary comments ahead of meeting, the FDA advised NRx that no additional nonclinical data or bridging studies would be required to support the NDA for the preservative-free formulation compared to the currently-approved preservative-containing formulation of ketamine. 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.

A separate Abbreviated New Drug Application for preservative-free ketamine in anesthesia and pain remains under review with an expected decision in summer 2026.

NRx Pharmaceuticals, Inc. 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 combination), both targeting severe mood and depressive conditions in high-risk patient populations.

NRX-100 has received Fast Track designation for suicidal ideation in depression, including bipolar depression, while NRX-101 holds Breakthrough Therapy designation for suicidal bipolar depression. Detailed updates will be provided once the company receives the final meeting minutes.

NRXP has traded between $1.58 and $3.84 over the past year. The stock closed February 13, 2026, trading at $1.80, up 4.05%, and rose further in the pre-market to $1.83, up 1.67%. Current market cap is $53.29M with average trading volume of 924,385.