Business
NRx Pharmaceuticals (Nasdaq:NRXP) Announces Path to New Drug Application with Real World Data and Broader Proposed Indication for NRX-100 (ketamine) Following Type C FDA Meeting
NRx together with Osmind, Inc. conducted an in-person meeting attended by leadership of the FDA Division of Psychiatry Products and leadership of the FDA
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"NRx together with Osmind, Inc. conducted an in-person meeting attended by leadership of the FDA Division of Psychiatry Products and leadership of the FDA Center for Drug Evaluation and Research (CDER)Oral guidance received at the meeting provides a path to filing an application for New Drug Approval of NRX-100 under already-awarded Fast Track Designation based on existing clinical trial data and Real World EvidenceBased on the guidance, NRx will seek a broader proposed indication for NRX-100 to serve patients with treatment-resistant depression who may have suicidality rather than only the subset with suicidality WILMINGTON, Del., Feb. 17, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that it has completed 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. 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. “We deeply appreciate the FDA’s meeting with us at the leadership level and guiding us to pursue a New Drug Application for NRX-100 for the benefit of the millions of Americans who tragica...