- NRx Pharmaceuticals is advancing a pipeline of innovative therapies targeting multibillion-dollar unmet needs in central nervous system disorders.
- The company’s lead candidate, NRX-100 (preservative free IV ketamine), NDA in process with the FDA, has been granted Fast Track designation by the FDA for acute suicidal depression, and a patent for this novel formulation has been filed with the U.S. Patent and Trademark Office.
- NRX-101 (oral D-cycloserine/lurasidone), has received FDA Breakthrough Therapy designation, expediting its development.
- HOPE Therapeutics, NRx’s interventional psychiatry subsidiary, is targeting $100M in forward looking revenue by year-end 2025, through development of a national clinic network treating suicidal depression, treatment-resistant depression, PTSD and related central nervous system (“CNS”) disorders.
- The company’s experienced leadership team has a proven track record in pharmaceutical development and commercialization.
- NRx is positioned to address large and growing markets with its novel depression treatments, non-opioid therapeutic solutions and directly helping patients in HOPE clinics nationwide.
NRx Pharmaceuticals (NASDAQ: NRXP) is a clinical-stage biopharmaceutical company developing therapies for central nervous system disorders, particularly suicidal depression and PTSD. The company is leveraging its patented NMDA receptor modulation platform with two drugs, NRX-100 (preservative-free ketamine) and NRX-101 (D-cycloserine/lurasidone), that have received FDA Fast Track and Breakthrough Therapy designations, respectively. Both address acute unmet medical needs, in that there is no FDA-approved medication for suicidal depression and PTSD. The only approved treatment today is electroshock therapy.
A New Drug Application (“NDA”) for its lead investigational drug, NRX-100 (preservative free intravenous ketamine), is being filed for use as treatment for suicidal depression, a condition for which existing treatments remain limited. FDA has approved the company’s Pediatric Study Plan and granted a $4.3 million filing fee waiver to support this application. Additionally, the company is working to bring NRX-101 (D-cycloserine/lurasidone) to the market; the product is positioned to be the first FDA-approved oral therapy for suicidal bipolar depression.
Both new drugs are part of the growing focus on neuroplastic therapies that treat life-threatening CNS diseases by stimulating the growth of new synaptic connections within the brain. Research has shown that suicidal depression is associated with high levels of NMDA receptor activity in the brain, with atrophy of brain cell connections. Administration of NMDA antagonist drugs such as NRX-100 and NRX-101 is associated in increased levels of brain glutamate, formation of new synapses, and documented clinical improvement in well-controlled clinical trials.
NRx has also established HOPE Therapeutics, a wholly owned subsidiary focused on delivering interventional psychiatric care through a nationwide clinic network. HOPE Therapeutics aims to become the first coordinated system of care for suicidal depression, treatment-resistant depression and PTSD, combining ketamine therapies, transcranial magnetic stimulation (“TMS”), digital therapeutics, and other precision psychiatry tools in a safe, professional clinical environment. NRx plans to spin HOPE out as an independent, publicly traded company in the near term.
NRx is headquartered in Wilmington, Delaware. HOPE is headquartered in Miami, Florida.
NRx Product Portfolio
NRx Pharmaceuticals’ pipeline includes multiple late-stage therapeutic candidates targeting psychiatric and neurological disorders:
- NRX-100: A preservative free intravenous ketamine formulation (patent pending); an NDA for the product is being filed with the FDA for acute suicidal depression, backed by strong clinical trial data and Fast Track designation from the FDA.
- NRX-101 (oral D-cycloserine/lurasidone): A patent protected oral therapy with a dual mechanism targeting NMDA and 5-HT2A receptors, designed for patients with suicidal treatment-resistant bipolar depression. The drug has received Breakthrough Therapy designation from the FDA; an NDA for Accelerated Approval is planned for 2025.
- Expanded Research: The company is further evaluating NRX-101 as a potential non-opioid treatment for chronic pain and as a therapy for complicated urinary tract infections.
NRx’s therapeutic pipeline is designed to address conditions with limited or no treatment options, with the potential to improve patient outcomes and expand the standard of care.
HOPE Therapeutics
HOPE Therapeutics, a wholly owned subsidiary of NRx Pharmaceuticals, is establishing a national network of psychiatry-led clinics focused on suicidal depression, treatment-resistant depression, PTSD and related central nervous system (“CNS”) disorders. Its care model integrates ketamine therapy, TMS, digital therapeutics, and supervised psychiatric support to deliver rapid, measurable outcomes.
The company is targeting more than 30 clinic acquisitions by year-end 2025. Recent progress includes agreements to acquire Kadima Neuropsychiatric Institute and Dura Medical and a letter of intent with Neurospa TMS, strengthening HOPE’s foundation in interventional psychiatry.
HOPE projects $100 million in forward looking annual revenue and profitability by year-end 2025. Positioned as a stand-alone care delivery company, HOPE offers NRx a potential future spinout opportunity to unlock additional shareholder value.
Market Opportunity
The need for innovative treatments in mental health and pain management is substantial. Suicide is a leading cause of death in the United States, claiming nearly 50,000 lives each year, with over 12 million adults seriously considering suicide annually, according to the CDC.
Suicidal depression, an acutely life-threatening condition, affects approximately 12 million Americans. Despite this prevalence, the only approved intervention remains electroconvulsive therapy (“ECT”), a treatment with significant side effects and limited access. NRx aims to address this urgent gap with NRX-100, a preservative-free intravenous ketamine formulation being developed as the first FDA-approved treatment for suicidal depression.
Additionally, approximately 7 million Americans suffer from bipolar depression, a condition where nearly half of patients will attempt suicide during their lifetime and one in five may die by suicide. NRX-101, NRx’s oral drug candidate, targets this critical unmet need as a potential first-in-class therapy specifically for bipolar depression.
Beyond mood disorders, chronic pain affects over 50 million individuals in the U.S., and PTSD impacts more than 12 million people—conditions for which few non-opioid or fast-acting treatments are available. By addressing these high-risk, underserved populations, NRx Pharmaceuticals is positioned to enter multiple billion-dollar markets and reshape the standard of care for severe psychiatric and neurological illnesses.
Leadership Team
Jonathan C. Javitt, Founder, Chairman and Chief Executive Officer of NRx and Co-CEO of HOPE, brings four decades of experience in pharmaceutical and medical device development. He has led blockbuster drug and device programs at major companies, including Allergan, Merck, and Novartis, and has served as an advisor to four U.S. presidential administrations.
Michael Abrams, Chief Financial Officer, has nearly 30 years of experience in finance, having served in executive roles as an SEC-licensed securities professional, followed by executive roles as a CFO, including positions at Arch Therapeutics and FitLife Brands. His expertise spans investment banking, corporate finance, and business strategy.
Matthew Duffy, Chief Business Officer, NRx, Co-CEO of HOPE, has over 35 years of experience in healthcare commercialization, business development and investment banking. He has held leadership roles at Pfizer, MedImmune, and Lev Pharmaceuticals. He has also served as an SEC-licensed professional at Laidlaw Venture Partners, and several other financial institutions, specializing in corporate strategy and partnerships.
Rick Panicucci, Chief Technology Officer, has more than 25 years of leadership in pharmaceutical manufacturing and process development. He has held key positions at Novartis, WuXi AppTec, and other major companies, leading multiple approved New Drug Applications.
For more information about the company, visit NRx’s website at https://ir.nrxpharma.com.
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://ibn.fm/NRXP
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