| Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] |
1. Organization
The Business
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”, the “Company”, “we”, “us” or “our”) is a clinical-stage bio-pharmaceutical company which develops and will distribute, through its wholly-owned operating subsidiary, NeuroRx, Inc., (“NeuroRx”), novel therapeutics for the treatment of central nervous system disorders including suicidal depression, chronic pain, and post-traumatic stress disorder (“PTSD”) and schizophrenia. All of our current drug development activities are focused drugs that modulate on the N-methyl-D-aspartate (“NMDA”) receptor in the brain and nervous system, a neurochemical pathway that has been disclosed in detail in our annual filings. The Company has two lead drug candidates – NRX-100, a preservative-free formulation of ketamine for intravenous infusion, and NRX-101, an oral fixed dose combination of D-cycloserine and lurasidone. NRX-100 and NRX-101 are in the process of submission for Food and Drug Administration (“FDA”) approval as follows:
| | 1. | An Abbreviated New Drug Application (“ANDA”) for NRX-100 was filed, with Priority Review requested, during the second quarter of 2025 with a first response received August 13, 2025. |
| | 2. | A New Drug Application (“NDA”) for NRX-100, originally initiated during the fourth quarter of 2024, is expected to be completed in September 2025. This follows the Company’s successful application for a waiver under the Prescription Drug User Fee Act ("PDUFA"), which is expected to save the Company approximately $4.3 million in filing fees and grant of Fast Track Designation for NRX-100 for “Treatment of Suicidal Ideation in Patients with Depression, including Bipolar Depression. The Company has applied to receive a Commissioner’s National Priority Voucher (CNPV), which could significantly reduce review time. |
| | 3. | An NDA filing for NRX-101 has been initiated with the transmission of the Module 3 manufacturing file to publishing. The drug was previously awarded Breakthrough Therapy Designation and accordingly the Company is requesting rolling review of the NDA. Breakthrough Therapy Designation is granted by the FDA to facilitate the development, and expedite the review of drugs to treat serious conditions meet an unmet medical need, and have demonstrated preliminary evidence of efficacy as determined by the FDA. The Company anticipates decision dates from the FDA for both its NDA applications potentially as early as year-end 2025 (NRX-100) and the first quarter of 2026 (NRX-101). |
In February 2024, NRx incorporated HOPE Therapeutics, Inc. (“HOPE”), a medical care delivery organization focused on providing cutting-edge, comprehensive interventional psychiatric treatment of the above conditions with the most effective treatments available, including NMDA-targeted and other neuroplastic drugs, such as ketamine, Spravato and NRX-101, neuromodulatory devices, such as Transcranial Magnetic Stimulation (“TMS”), digital therapeutics, and medication management.
NeuroRx is organized as a traditional research and development (“R&D”) company, whereas HOPE is organized as a medical care delivery company intended to own and/or operate clinics that serve patients with suicidal depression, PTSD, and other serious Central Nervous System (“CNS”) disorders. Management’s plan, through the establishment of HOPE, is to transform NRx from a pre-revenue biotechnology company to a revenue-generating enterprise that continues to develop life-saving drugs and technologies through NeuroRx, while also treating patients through HOPE.
During the second quarter of 2025 and in the subsequent period, key achievements by the Company in support of its overall mission to improve and save the lives of patients affected by central nervous system disorders including suicidal depression, chronic pain, post-traumatic stress disorder and schizophrenia include the following:
Drug Development
| | ● | Grant of Fast Track Designation for NRX-100 from the FDA for all indications and types of depression and related disorders based on its potential to satisfy an unmet medical need. This designation represents an approximately 10-fold expansion of the addressable market to 13 million Americans, compared to the original Fast Track Designation issued in 2017 for bipolar depression alone. The Designation letter contains a specific finding that NRX-100 addresses an “unmet medical need.” This is a specific qualifying requirement for the Commissioner’s National Priority Voucher Program. |
| | ● | Filing of an ANDA for NRX-100 (preservative-free intravenous ketamine). |
| | ● | Filing of Commissioner’s National Priority Voucher application for intravenous ketamine (NRX-100). |
| | ● | Submission of stability data for NRX-100 to the manufacturing data on file with FDA sufficient to support three years of room temperature shelf stability for NRX-100. |
| | ● | Submission of draft labeling for NRX-100 in the treatment of suicidal depression based on the Fast Track Designation received. |
| | ● | Completion of a toxicology assessment of Benzethonium Chloride, documenting its lack of “Generally Recognized as Safe” (GRAS) status and lack of safety data to support its use in intravenous presentations of ketamine. |
| | ● | Filing of a Citizen’s Petition with the U.S. Food and Drug Administration to seek the removal of benzethonium chloride, a toxic preservative, from all ketamine products for intravenous administration. |
| | ● | Filing of a patent application for NRX-100, the Company’s proprietary preservative-free formulation of intravenous ketamine. |
| | ● | Receipt of filing fee waiver from the FDA for NRX-100. |
| | ● | Filing of module 3 manufacturing data to support a New Drug Application for NRX-101 in the treatment of patients with suicidal bipolar depression and akathisia despite treatment with already-approved medication. |
Interventional Psychiatry Clinics (HOPE Therapeutics)
| | ● | Execution of definitive Purchase Agreement and receipt of final regulatory clearance from Florida’s Agency for Health Care Administration (“ACHA”) to proceed with closing the acquisition of Dura Medical. |
| | ● | Execution of binding letter of intent to acquire the assets of NeuroSpa TMS of Tampa, FL. |
| | ● | Execution of a binding letter of intent to acquire a 49% interest in Cohen and Associates, LLC. |
| | ● | Receipt of approval pending legal stipulations for $7.8 million of debt financing to support the acquisition of Dura Medical, NeuroSpa TMS, and Cohen Psychiatry. |
| | ● | Execution of a definitive purchase agreement, subject to standard closing conditions and agreement between the parties regarding the resolution of ongoing discussions, to purchase the non-clinical assets of Kadima Neuropsychiatry Institute. |
| | ● | Execution of a non-binding term sheet for a strategic investment from a global medical device manufacturer into HOPE. |
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