WILMINGTON, DE — NRx Pharmaceuticals Inc. (Nasdaq: NRXP) moved closer to a potential 2026 launch of preservative-free ketamine after the Food and Drug Administration found no major deficiencies involving the drug or its manufacture during an initial application review, leaving a packaging-related matter as the remaining issue.
The FDA requested an attestation that the vial’s syringe-connection component is manufactured in the same manner as those used for three approved drugs, according to NRx. The company has submitted the document, but the application remains under review.
NRx has begun producing 5 million doses as potential launch inventory and plans to manufacture 1 million doses a month after commercialization. It also appointed Glenn Tyson as its first chief commercial officer and retained a launch team.
The company is separately preparing a new drug application seeking approval of the intravenous treatment, called NRX-100, for depression. NRx is targeting a 2027 decision and plans to rely partly on real-world evidence involving more than 65,000 patients.
NRx reported that the evidence showed intravenous ketamine produced comparable or better results than intranasal S-ketamine, with a faster onset of action. The findings were presented at a meeting of the American Society of Clinical Psychopharmacology in Miami.
The company was also selected as the prime contractor for a federally backed trial evaluating NRX-101 with robotic transcranial magnetic stimulation in patients with treatment-resistant depression. Anticipated funding from the Defense Advanced Research Projects Agency exceeds $11.5 million but remains subject to completion of a contract.
The Phase 2/3 SPARC-TMS study will involve McLean Hospital and several U.S. military treatment facilities. Trial information is available at www.clinicaltrials.gov under identifier NCT07227103, while additional program information is available at www.nrxdefense.com.
NRx has positioned NRX-101 primarily as a treatment for suicidal bipolar depression. The new study could broaden its potential market to treatment-resistant depression, which the company estimates affects more than 15 million Americans.
Through HOPE Therapeutics, NRx also added clinical locations in Sarasota and Boca Raton, Florida. The subsidiary became the first commercial U.S. site to treat patients using Zeta Surgical’s FDA-cleared navigation system for transcranial magnetic stimulation, according to the company.
NRx has also invested in forming GeNeuro Inc., which holds monoclonal-antibody drug candidates targeting proteins associated with neurological and autoimmune disorders.
GeNeuro plans a French government-supported trial of temelimab in schizophrenia and is targeting July 2027 for the first human study of GNK-301 in amyotrophic lateral sclerosis. More information is available at www.geneuro.us.
NRx’s net loss narrowed to $18 million during the first six months of 2026 from $23.1 million a year earlier. Its operating loss widened to $11.3 million from $7.6 million as research, personnel and commercial-preparation costs increased.
Cash and equivalents rose to $26.7 million as of June 30 from $7.8 million at the end of 2025, largely because of a public stock offering that generated $22.3 million in gross proceeds.
Management expects its cash, anticipated clinic revenue and access to an at-the-market stock offering to fund operations for at least one year.
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