NRx Builds Momentum From FDA Progress To Strategic Expansion

EQS-News: Benzinga / Key word(s): Healthcare NRx Builds Momentum From FDA Progress To Strategic Expansion 27.02.2026 / 14:34 CET/CEST The issuer is solely responsible for the content of this announcement. By Meg Flippin, Benzinga

DETROIT, MICHIGAN - February 27, 2026 (NEWMEDIAWIRE) - NRx Pharmaceuticals, Inc. (NASDAQ: NRXP), a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system (CNS) disorders, specifically suicidal bipolar depression, chronic pain and PTSD, is making further inroads on that front. 

The company just announced it completed an in-person meeting with the U.S. Food and Drug Administration (FDA) over NRX-100, its developmental drug for treating suicidal depression. NRX-100 is a preservative-free intravenous (IV) ketamine formulation. The proprietary formulation is designed to be a safer alternative to existing ketamine preparations and avoid potential toxicity associated with preservatives found in current ketamine preparations designed for anesthetic purposes, reports the company.

On The Way To New Drug Application 

The Type C guidance meeting was run by leaders of the FDA Division of Psychiatry Products, the FDA Office of Neuroscience and the FDA Center for Drug Evaluation and Research. NRx said it walked away from the meeting confident 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 trials, together with confirmatory evidence from more than 65,000 patients identified in the Real World Evidence dataset. The company said it will also seek a broader indication for NRX-100 to serve patients with treatment-resistant depression in the context of suicidality, rather than only the subset of patients with suicidality. 

Approval of a New Drug Application for the treatment of depression could give NRx access to what it estimates to be a $2 billion ketamine market currently served by Intranasal S-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 tragically form a plan to end their lives each year,” said Dr. Jonathan Javitt, founder, Chairman and CEO of NRx Pharmaceuticals. “Based on the guidance received, we will be using the 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.”