NRx Pharmaceuticals, Inc. (NRXP) announced that it has completed a 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 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. Importantly, the agency advised that no additional nonclinical data or bridging studies would be required to support the NDA.
Based on this guidance, NRx plans to seek a broader indication for NRX-100 to serve patients with treatment-resistant depression who may have suicidality, rather than limiting the application to those with suicidality alone. The company will work with the FDA in the coming weeks to finalize the statistical analysis protocol for the Real-World Evidence dataset.
Executives and trial investigators described the meeting as a pivotal milestone, emphasizing the potential of NRX-100 to address urgent unmet needs in depression, including among veterans and first responders.
Detailed updates will be provided once the company receives the final meeting minutes.
The discussion included input from Osmind, Inc., Psychiatry Products, and leadership of the FDA's Center for Drug Evaluation and Research (CDER), as well as the Office of Surveillance and Epidemiology (OSMID), providing guidance on the regulatory path forward.
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%.
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