$300 Million in Milestones Plus Tiered Double-Digit Royalties from Accepted Terms to License and Distribute NRX-100 Drug: NRx Pharmaceuticals, Inc. (Nasdaq: NRXP)
Developing NRX-101, an FDA-Designated Investigational Breakthrough Therapy for Suicidal Treatment-Resistant Bipolar Depression and Chronic Pain.
Aiming to be the First FDA-Approved Medication to Treat Suicidal Depression
Designed to Help Address the Needs of Over 13 Million Americans who Seriously Consider Suicide Each Year (CDC).
New Drug Application for Treatment of Suicidal Depression; Planned NDA for Accelerated Approval for Bipolar Depression in People at Risk of Akathisia.
Accepted Non-Binding Potential Terms to License and Distribute NRX-100 Drug Providing Over $300 Million in Milestones Plus Tiered Double-Digit Royalties.
Application to Uplist to NASDAQ Global Market from NASDAQ Capital Market
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. NRXP is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain
NRXP has partnered with Alvogen Pharmaceuticals around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRXP is working on a New Drug Application for NRX-100 (IV ketamine) in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRXP was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
Intravenous ketamine is widely accepted as a standard of care for acute treatment of suicidal depression, in the absence of an FDA-labeled product; the only treatment currently approved by the FDA is electroconvulsive therapy (ECT). According to the CDC, 3.8 million Americans make a plan for suicide each year. This represents a $3-5 billion market at expected pricing. Based on the data in the trials referenced above, the Company's regulatory counsel encouraged the Company to file an NDA for suicidal depression for NRX-100.
In a January 2025 report, respected investment analysis firm D. Boral Capital assigned NRXP a $31 Price Target. The full report may be viewed at this link: https://www.nrxpharma.com/wp-content/uploads/2025/01/HOPE-Therapeutics-Advances-With-Kadima.pdf.
Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
On March 17th NRXP announced its financial results for the quarter and year ended December 31, 2024, and provided a business update. The announcement included the following key highlights:
NRXP initiated filing of a New Drug Application ("NDA") to the FDA for NRX-100 (IV Ketamine) for the treatment of Suicidal Depression; planned filing of an NDA for Accelerated Approval under Breakthrough Designation and Priority Review of NRX-101 for the treatment of bipolar depression in people at risk of akathisia. Both have anticipated PDUFA dates prior to December 31, 2025
NRXP has accepted non-binding potential terms from a commercial pharmaceutical company to license and distribute NRX-100, providing over $300 million in milestones plus tiered double-digit royalties based on net sales
NRXP retained a leading regulatory law firm to file a citizen's petition with the US Food and Drug Administration ("FDA") to remove benzethonium chloride – a toxic preservative -- from presentations of ketamine intended for intravenous use; planned 2Q25 filing of an Abbreviated New Drug Application ("ANDA") for the use of preservative-free ketamine in all current indications
Wholly owned subsidiary HOPE Therapeutics, signed non-binding letters of intent to acquire three precision psychiatry centers and is currently completing financial due diligence and definitive agreements. Currently negotiating the terms for the acquisition of six additional centers
The HOPE acquisitions are planned to form the foundation for a national network offering interventional psychiatry services to treat suicidal depression, post-traumatic stress disorder ("PTSD") and related conditions
NRXP received and negotiating a term sheet from a publicly-traded strategic investor currently engaged in manufacturing Transcranial Magnetic Stimulation ("TMS") devices to provide capital in support of expansion of further HOPE clinic acquisitions.
NRXP has engaged BTIG as financial advisor for clinic acquisition and capital formation; leading global financial services firm specializing in investment banking, institutional trading, research, and related brokerage services for strategic growth opportunities.
NRXP regained compliance with the NASDAQ market value of listed securities ("MVLS") requirement.
Substantially reduced operating costs compared to prior year
Management continues to forecast, although no assurances can be given, profitability on a forward-looking run-rate basis by year end 2025
NRXP filed Module 3 (manufacturing) of its New Drug Application ("NDA") for NRX-100 (preservative-free sterile IV ketamine) in a tamper-resistant, diversion resistant packaging presentation in the fourth quarter of 2024. NRX-100 was previously granted Fast Track Designation by FDA in combination with use of NRX-101. Ketamine efficacy data from four clinical trials are intended to support the filing. Three manufacturing lots are now complete, with filed stability data suitable for shelf life exceeding two years at room temperature. The anticipated PDUFA date for this NDA is prior to December 31, 2025.
NRX-100 is poised to address the over $3 billion Suicidal Depression market in the US.
NRXP has accepted non-binding potential terms from a commercial pharmaceutical company to license and distribute NRX-100 (preservative-free IV ketamine) that provides for over $300 million in potential milestones plus a tiered double-digit royalty, subject to further due diligence and finalized agreement.
In December 2024 NRXP demonstrated long term stability and sterility of a patentable formulation of preservative-free ketamine, despite longstanding commercial practice of adding benzethonium chloride as a preservative to commercially supplied ketamine. This preservative is a known caustic and toxic substance that has previously demonstrated corneal neurotoxicity and conjunctival toxicity in patients, and generalized neurotoxicity in the laboratory at microgram concentrations. The concentration in current ketamine preparations is substantially higher, with an extensive body of scientific literature documenting concern. Additionally, chronic administration of ketamine is known to increase the risk of cystitis ( Ref); the relationship of this adverse event to benzethonium chloride is unknown. Now that a long-term stable and sterile preservative-free formulation is available, the Company is filing a citizens petition to seek removal of benzethonium chloride from the human and veterinary ketamine drug supply.
NRXP believes that the preservative-free feature of NRX-100 will be deemed of benefit to patients and is consistent with evolving federal policy on toxic preservatives in the US food and drug supply chain. Therefore, in addition to the NDA designed to add treatment of depression to the current ketamine label, the Company plans to file an Abbreviated New Drug Application ("ANDA") in the second quarter of 2025 for the use of preservative-free ketamine in all currently indicated human and veterinary applications. The Company believes it has met all requirements of the ANDA approval process, has demonstrated manufacturing capacity in excess of one million vials per month, and is prepared to supply the broad ketamine market.
As a next-generation product, NRXP has developed a novel, patentable pH neutral formulation of ketamine (designed as HTX-100) based on a proprietary excipient that overcomes ketamine's insolubility, that will be suitable for both intravenous and subcutaneous administration. Initial laboratory lots demonstrate shelf stability and ongoing stability is being assessed. Ketamine in its current commercial presentations cannot be administered subcutaneously because of its high acidic (pH 3.5-4.0) properties, an acidity range that is known to cause pain and skin ulcers. This product is expected to undergo clinical testing in 2025/2026 and be ready for FDA approval in late 2026. Oral forms of ketamine and intranasal racemic ketamine have failed to demonstrate sufficiently stable blood levels to replace intravenous ketamine. However, a ketamine formulation capable of achieving clinical benefit via subcutaneous use – in the manner that diabetes drugs are currently administered – could facilitate far broader clinical use of ketamine to treat life-threatening CNS diseases.
NRXP has retained a leading regulatory law firm to file the citizen's petition with the US Food and Drug Administration to remove benzethonium chloride, a known neurotoxic substance, from presentations of ketamine intended for intravenous use. NRXP believes that the preservative-free feature of NRX-100 will be deemed of benefit to patients because of the known toxicity of benzethonium chloride in current generic products.
NRX-101 (oral D-cycloserine/lurasidone) Bipolar depression affects approximately seven million people in the US. Current treatment options all carry the risk of suicide and akathisia, a side-effect of serotonin active antidepressants which is closely related to suicide. People with bipolar depression and akathisia or suicidality are at imminent risk of self-harm. These patients need better treatment options urgently.
NRXP announced its intention to file an NDA for Accelerated Approval under Breakthrough Designation and Priority Review of NRX-101 for the treatment of bipolar depression in people at risk of akathisia, based on the Phase 2b/3 and STABIL-B data. Three manufacturing lots are now complete with more than 12 months of room temperature shelf-stability. The anticipated PDUFA date for this application is prior to December 31, 2025.
NRXP estimates that the market for the initial indication is over $2 billion, while the broad bipolar market could exceed $5 billion.
Disclosure listed on the CorporateAds website
Media Contact
Company Name: NRx Pharmaceuticals, Inc.
Contact Person: Matthew Duffy, Chief Business Officer
Email: Send Email
Phone: 484 254 6134
Address: 1201 Orange Street Suite 600
City: Miami
State: Florida
Country: United States
Website: https://www.nrxpharma.com/
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