In April 2026, NRx Pharmaceuticals, Inc. (the "Company") announced the incorporation of NRx Defense Systems, Inc. ("NRXD"), a Florida-based research and development subsidiary charged with the development of neuroplastic treatments that combine D-cycloserine with Transcranial Magnetic Stimulation ("TMS") under robotic-enabled neuro-navigation, using already developed technology. The Company anticipated NRXD participating in future government and non-governmental research and development, based on phase I and II research conducted by the Company's Chief Medical Innovation Officer.
On July 21, 2026, NRXD received a letter from the Defense Advanced Research Projects Agency ("DARPA"), Defense Sciences Office (DSO), notifying the Company that its proposal to conduct a clinical trial, entitled Synaptic Plasticity Augmented Rapid Circuit Stimulation (SPARC-TMS) had been selected by DARPA for negotiation of a potential award.
The protocol for the SPARC-TMS trial was approved as a phase 2/3 trial by the US Food and Drug Administration (FDA) and is posted on www.clinicaltrials.gov (NCT07227103). The trial aims to demonstrate the potential efficacy of robotic-enabled Transcranial Magnetic Stimulation combined with NRX-101 (combined D-cycloserine/lurasidone) in achieving remission from depression. NRX-101 which is patented by the Company was previously awarded Breakthrough Therapy Designation by the FDA. The study is planned to be conducted at Harvard Mclean hospital, at clinics operated by HOPE Therapeutics, and at designated military treatment facilities including the Walter Reed National Military Medical Center.
The selection of the Company's proposal for contract negotiation does not constitute a notice of award, a commitment by DARPA to make an award or an authorization for the Company to incur costs. Any potential award remains subject to the successful negotiation of definitive terms between DARPA/DSO and NRXD.