NRx Pharmaceuticals Launches Breakthrough One-Day Treatment Clinic in Florida as FDA Pathway and Clinical Data Strengthen Growth Outlook; $NRXP

MIAMI - Amzeal -- NRx Pharmaceuticals, Inc. (N A S D A Q: NRXP) is accelerating its push to transform the treatment landscape for severe mental health disorders with the launch of a new interventional psychiatry clinic in Palm Beach, Florida offering a one-day treatment protocol for depression and PTSD.

The company's innovative approach combines ketamine-based therapies, transcranial magnetic stimulation (TMS), neuroplastic medications, hyperbaric oxygen therapy, and physician-led psychotherapy—a multi-modal treatment platform designed to deliver rapid clinical improvement for patients suffering from treatment-resistant conditions.

Published clinical research has demonstrated an 87% clinical response rate in patients receiving short-term neuroplastic therapy protocols for treatment-resistant depression, highlighting the transformative potential of this approach.

With millions of patients struggling with severe depression and PTSD, NRx Pharmaceuticals is positioning itself as a next-generation leader in neuropsychiatric medicine and interventional mental health care.

New Palm Beach Clinic Expands HOPE Therapeutics Network

On March 9, the company announced the opening of its Palm Beach, Florida clinic, now accepting patients for advanced treatment of depression and post-traumatic stress disorder.

The facility becomes the latest location within the company's HOPE Therapeutics clinic network, which is focused on delivering cutting-edge neuroplastic treatments nationwide.

NRXP's treatment model integrates:

• Ketamine and other neuroplastic medications
• Transcranial Magnetic Stimulation (TMS)
• Hyperbaric oxygen therapy
• Physician-guided psychotherapy

Pilot programs incorporating these therapies have demonstrated up to a 90% return-to-function rate in patients suffering from depression and PTSD.

Additionally, scientific studies have shown TMS may improve memory and cognitive function in patients with Alzheimer's disease and traumatic brain injury, expanding potential future treatment applications.

The Palm Beach location also benefits from the company's nationwide partnership with neurocare Group AG, bringing advanced non-invasive psychiatric technologies to a growing network of treatment centers.

Breakthrough Drug Development Pipeline Targets Massive Unmet Need

NRx Pharmaceuticals is simultaneously advancing a powerful clinical pipeline focused on serious central nervous system disorders.

The company's lead program, NRX-101, has been granted FDA Breakthrough Therapy designation for the treatment of suicidal treatment-resistant bipolar depression and chronic pain.

This therapy is designed to address the needs of more than 13 million Americans who seriously consider suicide each year, according to data from the Centers for Disease Control and Prevention.

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NRX-101 is being developed in collaboration with Alvogen Pharmaceuticals and may also offer a non-opioid treatment pathway for chronic pain, representing an additional large market opportunity.

FDA Meeting Confirms Path Toward New Drug Approval for NRX-100 Ketamine Therapy

In February, NRXP announced the successful completion of an in-person Type C meeting with the U.S. Food and Drug Administration at the agency's headquarters.

The meeting included leadership from:

• The FDA Division of Psychiatry Products
• The FDA Office of Neuroscience
• The FDA Center for Drug Evaluation and Research (CDER)

Based on guidance received, the company believes it now has a clear pathway to filing a New Drug Application (NDA) for NRX-100, its preservative-free intravenous ketamine formulation.

The application will be supported by:

• Data from well-controlled clinical trials conducted with the U.S. National Institutes of Health
• Large Real-World Evidence datasets
• Confirmatory clinical analyses

Importantly, the FDA advised the company that no additional nonclinical data or bridging studies would be required to review the preservative-free formulation.

NRXP plans to seek a broader treatment indication, targeting patients with treatment-resistant depression associated with suicidality rather than only the most acute suicidal subset.

Real-World Evidence From 70,000 Patients Strengthens Regulatory Case

NRXP has licensed Real-World Evidence data from more than 70,000 patients in the United States treated with intravenous ketamine or nasal S-ketamine for depression and suicidal ideation.

This dataset is expected to play a pivotal role in the company's regulatory submission for Accelerated Approval of NRX-100 under FDA Fast Track designation.

Preliminary analysis of a 20,000-patient subset demonstrated rapid resolution of depression symptoms and suicidal ideation following ketamine treatment.

These results were found to be consistent with prior randomized clinical trials and compare favorably with currently approved therapies.

Notably, no medications are currently approved specifically to treat suicidal ideation, leaving electroconvulsive therapy as the only FDA-approved intervention for acute cases.

If approved, NRX-100 could represent a major breakthrough in psychiatric medicine.

Partnership With neurocare Group Expands Nationwide Treatment Network

NRXP recently announced a strategic collaboration with neurocare Group AG to develop a nationwide network of clinics delivering integrated neuroplastic therapies.

The combined treatment platform includes:

• Transcranial Magnetic Stimulation
• Ketamine and other neuroplastic drugs
• Hyperbaric oxygen therapy
• Structured psychotherapy programs

Recent scientific publications show this integrated approach has achieved 87% response rates and 72% remission rates in patients with treatment-resistant depression.

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The program will leverage more than 400 installed Apollo® TMS systems nationwide, accelerating the rollout of advanced mental health treatments.

Future research initiatives between the two companies will also explore applications in:

• Bipolar depression
• Autism spectrum disorders
• Traumatic brain injury

World-Class Clinical Leadership Strengthens Innovation Strategy

NRXP recently appointed Professor Joshua C. Brown, MD, PhD, as its Chief Medical Innovation Officer.

Dr. Brown is widely recognized as a pioneer in Transcranial Magnetic Stimulation research and currently serves as:

• President of the Clinical TMS Society
• Editor-in-Chief of the Transcranial Magnetic Stimulation Journal

He has extensive research experience in neuroplasticity and psychiatric recovery, as well as work advancing TMS treatment strategies for military personnel, veterans, and first responders.

The company's clinical leadership team includes physicians trained at leading institutions such as:

• Harvard University
• Johns Hopkins University
• Georgetown University

Debt-Free Balance Sheet Sets Stage for Accelerated Growth

In December, NRXP eliminated all remaining balance sheet debt through a strategic equity conversion totaling $5.4 million, leaving the company with a clean capital structure.

The debt-free balance sheet positions the company to pursue:

• Clinic network expansion
• Drug development milestones
• Regulatory submissions
• Strategic partnerships

Heading into 2026, the company believes it is positioned for significant operational and clinical growth.

Analyst Coverage Sees Significant Upside Potential

Independent analyst firm D. Boral Capital has issued a Buy rating on NRXP with a $34 price target, reflecting the potential value of the company's clinical pipeline, treatment network expansion, and regulatory progress.

The full analyst report can be accessed at:
https://www.nrxpharma.com/wp-content/uploads/2025/11/HOPE-Therapeutics-NRXP-Executes-Florida-Roll-out-of-Ampa-O.pdf

Positioned at the Intersection of Breakthrough Psychiatry and a $750 Million Ketamine Market

NRx Pharmaceuticals is developing KETAFREE™, a proprietary preservative-free ketamine formulation intended to improve safety and clinical usability.

The current global generic ketamine market is estimated at approximately $750 million annually, presenting a meaningful commercial opportunity for innovative formulations and delivery models.

By integrating drug development, clinical treatment networks, and neuroplastic therapy technologies, NRXP is building a comprehensive platform aimed at transforming the treatment of depression, PTSD, and other severe neurological conditions.

About NRx Pharmaceuticals

NRx Pharmaceuticals, Inc. (N A S D A Q: NRXP) is a clinical-stage biopharmaceutical company developing therapies based on its NMDA platform for the treatment of central nervous system disorders including suicidal bipolar depression, chronic pain, and PTSD.

Company Contact
NRx Pharmaceuticals, Inc. (N A S D A Q: NRXP)
Matthew Duffy – Chief Business Officer
Phone: (484) 254-6134
Email: mduffy@nrxpharma.com

Company Website:
https://www.nrxpharma.com/

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