NRx Pharmaceuticals reported a net loss of $18.0 million for the six months ended June 30, 2026, compared to $23.1 million in the prior year period. The company closed an underwritten public offering of common stock with gross proceeds of $22.3 million, bringing cash and cash equivalents to approximately $26.7 million as of June 30, 2026. Key operational milestones include receiving a complete response letter for its ANDA for preservative-free ketamine (NRX-100) with only a minor packaging deficiency remaining, initiating commercial-scale manufacturing of five million launch doses, and being selected by DARPA as prime contractor for the SPARC-TMS trial with anticipated non-dilutive funding exceeding $11.5 million. The company also appointed Glenn Tyson as its first Chief Commercial Officer to support the anticipated 2026 commercialization of ketamine. NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for central nervous system disorders.

NRX Pharmaceuticals received a final determination from the FDA on its Abbreviated New Drug Application for preservative-free ketamine, noting no major deficiencies in drug components but identifying a major deficiency regarding the twist-off cap of the luer lock vial due to potential deformation risks. Following an August 6, 2026 clarification meeting attended by senior FDA leadership, the agency committed to immediately reinitiating review and completing it in the shortest possible timeframe after receiving signed manufacturer certifications confirming production on existing approved lines. Management views the absence of drug-related deficiencies as a positive outcome, given that only 14% to 18% of ANDAs achieve first-round approval, and remains optimistic about resolving the packaging issue to enable commercial sales in 2026 amidst recognized ketamine shortages. NRX Pharmaceuticals operates in the pharmaceutical industry, developing and seeking regulatory approval for generic drug products.

NRx Pharmaceuticals, Inc. announced that its research and development subsidiary, NRx Defense Systems, Inc., received a notification from the Defense Advanced Research Projects Agency (DARPA) regarding a potential award. DARPA selected the company's proposal to conduct a clinical trial titled Synaptic Plasticity Augmented Rapid Circuit Stimulation (SPARC-TMS) for negotiation. The FDA-approved phase 2/3 trial aims to evaluate the efficacy of combining robotic-enabled Transcranial Magnetic Stimulation with NRX-101 to achieve remission from depression. The study will take place at Harvard McLean Hospital, HOPE Therapeutics clinics, and military facilities such as Walter Reed National Military Medical Center. This selection does not guarantee a final contract award. NRx Pharmaceuticals, Inc. is a biopharmaceutical company developing neuroplastic treatments.