- Business
- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) is a clinical-stage biopharmaceutical company developing therapeutics based on its proprietary N-methyl-D-aspartate (NMDA) platform for central nervous system disorders, including suicidal bipolar depression, post-traumatic stress disorder (PTSD), and chronic pain. The company's lead product candidates include NRX-100, a preservative-free intravenous ketamine formulation granted Fast Track Designation by the U.S. FDA for treating suicidal ideation in depression including bipolar depression, with an Abbreviated New Drug Application (ANDA) for KETAFREE™ received and deemed substantially complete by the FDA in December 2025; and NRX-101, an oral fixed-dose combination of D-cycloserine and lurasidone awarded Breakthrough Therapy Designation for suicidal treatment-resistant bipolar depression, with potential applications in chronic pain, augmentation of transcranial magnetic stimulation, and complex urinary tract infections. Founded in 2015 and headquartered in Wilmington, Delaware, NRx Pharmaceuticals targets patients with acute and sub-acute suicidal ideation and behavior, primarily in the United States, through license agreements with entities including Alvogen, Inc., Lotus Pharmaceutical Co. Ltd., Apkarian Technologies, Glytech, LLC, and Sarah Herzog Memorial Hospital.
In recent developments, the company has advanced dual regulatory pathways for its ketamine-based therapies, including filing an NDA for NRX-100 under Fast Track Designation and pursuing ANDA approval for KETAFREE™ with a targeted launch in July 2026, while preparing an NDA submission for NRX-101 leveraging NIH trial data and new agreements with French health authorities. NRx Pharmaceuticals is expanding through its affiliate HOPE Therapeutics with announced acquisitions of Kadima Neuropsychiatry Institute, Dura Medical, NeuroSpa TMS Holdings, and Cohen and Associates, LLC, supported by $7.8 million in debt financing and negotiations for additional clinic partnerships in Florida, the Mid-Atlantic, and Midwest aiming for $100 million in forward pro-forma revenue by year-end 2025. These moves establish a national network of interventional psychiatry clinics to deliver NRx's therapies, with initial targets accretive to revenues and EBITDA. The company maintains operations focused on the U.S. market, with its pipeline addressing high unmet needs in neuroplastic therapies for veteran suicide prevention and beyond.