FDA Approval of Suitability Petition on Preservative-Free Ketamine Drug Supports $40 Analyst Target; $3 Billion Suicidal Depression Market: $NRXP

By: PRLog

September 24, 2025 at 14:48 PM EDT

NRx Pharmaceuticals, Inc. (N A S D A Q: NRXP) $NRXP Suitability Petition is required for shift from multidose packaging of ketamine to single-patient dose preservative free ketamine

MIAMI - Sept. 24, 2025 - PRLog -- Developing NRX-101, an FDA-Designated Investigational Breakthrough Therapy for Suicidal Treatment-Resistant Bipolar Depression and Chronic Pain.

Designed to Help Address the Needs of Over 13 Million Americans who Seriously Consider Suicide Each Year (CDC).

H.C. Wainright Analyst Report Cites Paradigm Shift in the Treatment of Depression with Suicidality; Assuming Coverage with Buy and $40 Price Target.

Notification of US Food and Drug Administration Approval of Suitability Petition for NRx's Proposed Strength of Preservative-Free Ketamine.

Dura Medical Acquisition Completed in Network of Interventional Psychiatry Clinics.

FDA Fast Track Designation for NRX 100 for Suicidal Ideation in Patients with Depression, Including Bipolar Depression.

Designation Includes an FDA Determination That NRX-100 has Potential to Address an Unmet Need.

$7.8 Million Debt Financing to Fuel NRXP HOPE Clinic Acquisitions with
Universal Capital, LLC.

Accepted Non-Binding Potential Terms to License and Distribute NRX-100 Drug Providing Over $300 Million in Milestones Plus Tiered Double-Digit Royalties.

NRx Pharmaceuticals, Inc. (N A S D A Q: 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.

H.C. Wainwright has issued a new Analyst Report on NRXP: "A Paradigm Shift in the Treatment of Depression With Suicidality" Assuming Coverage With a Buy and $40 Price Target. The full report may be accessed at this direct link: https://hcwco.bluematrix.com/links2/secure/pdf/acdd3260-630e-48e6-9c2f-03fbc0be37d6

Notification of US Food and Drug Administration Approval of Suitability Petition for NRx's Proposed Strength of Preservative-Free Ketamine

On September 24^th NRXP announced that it was notified by the United States Food and Drug Administration (FDA) that a Suitability Petition has been granted for the strength proposed by the Company for its planned single-patient, preservative-free ketamine product (KETAFREE™).

Currently, ketamine is sold in multi-dose vials that contain Benzethonium Chloride, a toxic preservative. The Suitability Petition that has been granted enables immediate re-filing of the NRXP Abbreviated New Drug Application for KETAFREE™. NRXP believes that this proposed product addresses two critical policy objectives as articulated by the current administration: (1) the re-shoring of strategically important drugs, particularly sterile products from foreign manufacturing sources, and (2) the "Make America Healthy Again" (MAHA) objective of removing toxic preservatives and colorants from foods and drugs. These objectives have been articulated on numerous occasions by FDA and HHS leadership.

Dura Medical Acquisition Completed in Network of Interventional Psychiatry Clinics

On September 8^th NRXP announced the closing of its acquisition of Dura Medical. Dura, together with the pending Neurospa TMS and Cohen and Associates acquisitions, are planned to provide a comprehensive service offering to patients at more than 8 locations along the West Coast of Florida. Dura is revenue generating and EBITDA positive.

Dura delivers a full range of precision psychiatry services for severe depression and PTSD, including Ketamine Therapy and Transcranial Magnetic Stimulation to Veterans and civilian patients.

Second Quarter 2025 Corporate Update

On August 18^th NRXP announced financial results for the quarter ended June 30, 2025, and provided a corporate update. As of June 30, 2025, NRXP had approximately $2.9 million in cash and cash equivalents. NRXP believes that its current cash position will support operations into 2026 and provide sufficient capital to reach expected regulatory inflection points.

The latest NRXP key developments included the following points:

NRXP Drug Development

Grant of expanded Fast Track Designation for NRXP 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.

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 NRXP NRX-100 addresses an "unmet medical need." This is a specific qualifying requirement for the Commissioner's National Priority Voucher Program.

NRXP Filing of Commissioner's National Priority Voucher application for intravenous ketamine (NRX-100).

Submission of draft labeling for NRXP NRX-100 in the treatment of suicidal depression based on the Fast Track Designation received.

Filing of an Abbreviated New Drug Application (ANDA) for NRXP NRX-100 (preservative-free intravenous ketamine).

Submission of stability data for NRXP NRX-100 to the manufacturing data on file with FDA sufficient to support three years of room temperature shelf stability for NRX-100.

Filing of a patent application for NRXP NRX-100.

Receipt of a PDUFA filing fee waiver from the FDA for NRXP NRX-100.

NRXP 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.

For more information on $NRXP visit: https://www.nrxpharma.com/ and https://compasslivemedia.com/case-study/nrx-pharmaceuticals/

Media Contact
Company Name: NRx Pharmaceuticals, Inc. (N A S D A Q: NRXP)
Contact Person: Matthew Duffy, Chief Business Officer

Company Website: https://www.nrxpharma.com/
Email: mduffy@nrxpharma.com
Phone: (484) 254-6134
Home Country: United States

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