NRX Pharmaceuticals, Inc.

NRx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company that develops and will distribute new treatments for central nervous system disorders, including suicidal depression, chronic pain, post-traumatic stress disorder (PTSD), and schizophrenia, through its wholly-owned subsidiary, NeuroRx, Inc. NRx is also the founder and majority owner of HOPE Therapeutics, Inc., a medical services company offering interventional psychiatry care for patients with treatment-resistant depression and PTSD, utilizing neuroplastic drugs, transcranial magnetic stimulation (TMS), digital therapeutics, and hyperbaric therapy. The company's current drug development focuses on drugs that enhance neuroplasticity by modulating the N-methyl-D-aspartate (NMDA) receptor. NRx has three lead drug candidates: NRX-100, a preservative-free formulation of ketamine for intravenous infusion; KETAFREE™, a generic preservative-free formulation of ketamine; and NRX-101, an oral fixed-dose combination of D-cycloserine (DCS) and lurasidone. An Abbreviated New Drug Application (ANDA) for KETAFREE™ was filed, with priority review requested in September 2025. The FDA approved the suitability of NRx's proposed strength. On November 6, 2025, the Company received a communication from the FDA with no significant deficiencies identified in the revised filing. On March 15, 2026, the Company received FDA's preliminary determination of no deficiency in the bioequivalence of KETAFREE™ to KETALAR®, the Reference Listed Drug. The company plans to initiate commercial sales of KETAFREE™ with FDA approval in Q3 2026. NRx has submitted a citizen petition to remove benzethonium chloride from commercial ketamine presentations. The company has completed manufacturing steps, including three reference batches of KETAFREE™, and demonstrated room temperature shelf stability anticipated to support a three-year shelf life at launch.