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NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reports Second Quarter 2025 Financial Results and Provides Corporate Update
NRx Drug Development Grant of expanded Fast Track Designation for NRX-100 from the FDA for all indications and types of depression and related disorders based
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"NRx Drug Development Grant of expanded 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.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 Commissioner’s National Priority Voucher application for intravenous ketamine (NRX-100).Submission of draft labeling for NRX-100 in the treatment of suicidal depression based on the Fast Track Designation received.Filing of an Abbreviated New Drug Application (ANDA) for NRX-100 (preservative-free intravenous ketamine). 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.Completion of a toxicology assessment of Benzethonium Chloride1, 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 a PDUFA 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. 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 Holdings 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 stipulation...