Final Step Completed for FDA Process Validation; Two-Year Stability for Preservative-Free Ketamine Treatment of Suicidal Depression by NRx Pharmaceuticals, Inc. (Nasdaq: NRXP)
WILMINGTON, Del., October 19, 2026 – NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) NRXP is developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. NRXP is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain.
NRXP is working on a New Drug Application for NRX-100 (IV ketamine) in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement.
Completion of Manufacturing Process Validation and Two-Year Stability of Preservative-Free Ketamine
NRXP has announced completion of three Process Validation lots of preservative free Ketamine produced under commercial conditions in anticipation of the November 10 GDUFA (Generic Drug User Fee Act) Goal Date. Process Validation is the final step in the drug manufacturing process required to demonstrate compliance with FDA Good Manufacturing Practices (GMP).
NRXP has also completed analysis of two-year room temperature real-time stability data on preservative-free ketamine demonstrating no deterioration in purity, potency, or sterility without the need for toxic preservatives. NRXP believes that these data will be consistent with a labeled shelf life of three years or longer.
$11 Million Dollar DARPA Prime Contract Award to Evaluate Robotic Magnetic Stimulation in Conjunction with NRX-101 for Treatment of Resistant Depression
NRXP subsidiary NRx Defense Systems has announced the award of an initial $11,177,757.27 contract issued by the Defense Advanced Research Projects Agency, a Branch of the United States Department of War. The underlying clinical trial, the Synaptic Plasticity Augmented Rapid Circuit Stimulation (SPARC-TMS) trial has been approved by the US Food and Drug Administration and will now begin enrolling patients.
The NRXP SPARC-TMS trial will be conducted at Harvard Medical School’s McLean Hospital, Arizona State University, and HOPE Therapeutics. Several leading military hospitals will also be affiliated with the study.
The focus of SPARC-TMS is to test whether an entire course of TMS delivered in a single day can effectively treat major depressive disorder when combined with mechanism-guided pharmacologic augmentation with NRXP NRX-101. TMS is thought to exert its therapeutic effects primarily through synaptic plasticity – the cellular basis of learning and memory. Synaptic plasticity is mediated by NMDA receptors. NRX-101 combines two drugs that may enhance NMDA receptor function through complementary mechanisms: d-cycloserine, an NMDA receptor partial agonist, and lurasidone, which has been shown to increase NMDA receptor expression through 5-HT7 antagonism.
The SPARC-TMS trial has the potential to serve as an FDA registration study for the use of NRXP NRX-101 in conjunction with TMS for people with Treatment Resistant Depression. a far larger population of patients, estimated at 8.9 million American adults with an estimated $44 Billion burden of illness.
European Patent Rights for GNK-301, a Novel Drug Candidate to Treat Amyotrophic Lateral Sclerosis (ALS)
GeNeuro, Inc., a subsidiary of NRXP has announced the award of a European Patent (EP 3 570 878 B1) entitled “Anti HERV K Envelope Antibody and Uses Thereof.” The patent, together with two previously-issued US patents (10,723,787 and 10,981,977) describes in detail the discovery that the envelope protein (K Env) of Human Endogenous Retrovirus K (HERV K) is found in the spinal fluid of more than 75% of people with Amyotrophic Lateral Sclerosis (ALS), is shown to be highly neurotoxic, and to produce the neurodegenerative findings of ALS.
HERVs are the remnants of viruses that infected primates between 2 and 5 million years ago and are now thought to have played a role in human disease. A monoclonal antibody against K Env (GNK-301) has been shown to block those neurotoxic effects in the same models. The patents are jointly owned by GeNeuro and the US Dept. of Health and Human Services.
The assets of the former Geneuro SA were awarded to NRXP GeNeuro, Inc. by the Courts of Switzerland in June 2026 and GeNeuro initiated manufacture of GNK-301 under Good Manufacturing Practices (cGMP) with the plan to initiate human Phase 1 trials of GNK-301 in the US and Europe in the latter half of 2027.
NRXP Subsidiary HOPE Therapeutics Training and Deployment of Zeta Surgical’s FDA-Cleared Robotic TMS System
NRXP has announced that its subsidiary, HOPE Therapeutics, Inc., is the first Interventional Psychiatry to deploy Zeta Surgical’s newly FDA-cleared Zeta TMS Robotic System, with clinical staff now in training ahead of deployment in Florida.
In June 2026, NRXP HOPE became the first commercial site in the United States to treat patients with the Zeta TMS Navigation System, which uses AI-driven image guidance to track the patient’s head in real time and show the clinician exactly where the coil sits relative to the MRI-guided brain target. The Zeta TMS Robotic System, which received FDA 510(k) clearance in July 2026, builds on that foundation.
The deployment supports SPARC-TMS, NRx’s FDA-approved Phase 2/3 trial of NRXP NRX-101 in combination with robotic TMS (NCT07227103). NRXP was selected by the Defense Advanced Research Projects Agency (DARPA) as prime contractor for SPARC-TMS.
Three Commercial Lots of Preservative-Free Ketamine Manufactured in Compliance with “Process Validation” Required Under FDA “Good Manufacturing Practices” (GMP).
Two-Year Stability Data Consistent with Projected Room-Temperature Stability to Three Years and Beyond with No Need for Toxic Preservatives.
$11 Million Dollar DARPA Prime Contract Award to Evaluate Robotic Magnetic Stimulation with NRX-101 Drug for Treatment of Resistant Depression,
Plans Underway to Expand SPARC-TMS Trial to Leading Military Hospitals.
Subsidiary GeNeuro, Inc., Awarded European Patent Rights for GNK-301, a Novel Drug Candidate to Treat Amyotrophic Lateral Sclerosis (ALS).
Subsidiary HOPE Therapeutics is the First Interventional Psychiatry Network to Deploy Zeta FDA-Cleared TMS Robotic System.
Worldwide Generic Ketamine Market Estimated at $750 Million Per Year.
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About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for serious central nervous system (CNS) disorders, with particular emphasis on suicidal depression, suicidal bipolar depression, PTSD and chronic pain. The company is developing therapies designed to address significant unmet medical needs, while also building HOPE Therapeutics, a clinical-care platform focused on advanced interventional psychiatric treatment.
Mission:
NRx’s mission is “to bring hope” through life-saving medicines for people living with unmet medical needs. The company says it seeks to use breakthrough science to make diseases that are difficult or previously untreatable more manageable, with a particular focus on bringing innovative treatments to patients with serious and life-threatening conditions.
NRx Pharmaceuticals, Inc. was legally incorporated in Delaware on September 18, 2017.
For more information on $NRXP visit: https://www.nrxpharma.com/ and https://compasslivemedia.com/case-study/nrx-pharmaceuticals/
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Media Contact
Company Name: NRx Pharmaceuticals, Inc.
Contact Person: Brian Korb, Managing Partner, astr partners
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Phone: (917) 653-5122
Address:1201 Orange Street Suite 600
City: Miami
State: Florida
Country: United States
Website: https://www.nrxpharma.com/
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