High-Impact Mental Health Platform Approaching a Defining Regulatory Moment: Eclipsing 70,000 Patients on Real World Use of Ketamine: N ASDAQ: NRXP
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MIAMI - Washingtoner -- As the mental health crisis deepens in the United States, few biotech companies are as directly aligned with both urgent unmet medical need and near-term regulatory catalysts as NRx Pharmaceuticals, Inc. (N A S D A Q: NRXP). With groundbreaking real-world data from over 70,000 patients, multiple FDA pathways underway, a newly debt-free balance sheet, and an expanding neuroplastic therapy ecosystem, NRXP is positioning itself as a potentially transformative force in the treatment of suicidal depression, bipolar depression, PTSD, and chronic pain.

A Massive, Unmet Need with No Approved Drug Solution

According to the CDC, more than 13 million Americans seriously consider suicide each year, yet no medication is currently FDA-approved to treat suicidal ideation. Today, electroconvulsive therapy (ECT) remains the only approved intervention—an invasive option often reserved as a last resort.

NRXP is attempting to change that paradigm.

The company is advancing NRX-100, a preservative-free intravenous ketamine, under FDA Fast Track designation for the treatment of suicidal depression and bipolar depression. Importantly, NRXP recently licensed Real World Evidence (RWE) data from over 70,000 U.S. patients, marking one of the largest datasets ever assembled for ketamine use in suicidality.

70,000-Patient Ketamine Dataset Headed to the FDA

On January 14, NRXP announced plans to submit this expansive real-world dataset to the FDA in support of Accelerated Approval of NRX-100.

Preliminary analysis of a 20,000-patient subset revealed:

• Rapid resolution of depression and suicidality
• Clinical responses consistent with prior randomized NIH-sponsored trials
• Outcomes that compare favorably to currently approved antidepressant products

The full 70,000-patient analysis will be presented to regulators, strengthening NRXP's case that ketamine—when delivered in a safer, preservative-free formulation—may finally offer a pharmacologic option for acute suicidality.

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If successful, NRXP could help bring the first FDA-approved drug for suicidal ideation to market.

KETAFREE™: A Cleaner Ketamine with a Clear Regulatory Path

Parallel to NRX-100, NRXP is pursuing approval of KETAFREE™, a preservative-free IV ketamine via an Abbreviated New Drug Application (ANDA). In December, the FDA confirmed the ANDA is "substantially complete" and assigned a PDUFA goal date of July 29, 2026.

Why this matters:

• Current ketamine products contain benzethonium chloride (BZT), a preservative not recognized as safe by the FDA
• KETAFREE™ eliminates this additive
• The global ketamine market is estimated at $750 million annually
• Manufactured in the U.S., aligning with MAHA initiatives to remove toxic substances from medicines and strengthen domestic supply chains

Approval of KETAFREE™ could establish NRXP as a differentiated supplier in a large, existing market—separate from the novel drug opportunity represented by NRX-100.

NRX-101: A Breakthrough Therapy with Expanding Potential

NRXP's flagship pipeline asset, NRX-101, is an FDA-designated Breakthrough Therapy for suicidal treatment-resistant bipolar depression. The oral combination drug (D-cycloserine + lurasidone) was specifically engineered to deliver neuroplastic benefits while mitigating hallucination risk—an innovation protected by composition-of-matter patents worldwide.

In late 2024, NRXP expanded NRX-101's potential by adding a new pipeline indication: augmentation of Transcranial Magnetic Stimulation (TMS).

Recent real-world and clinical data suggest:

• 87% clinical response
• 72% remission
• Achieved after a single day of TMS combined with oral D-cycloserine

With projections that over 1 million Americans per year may receive TMS by 2030, this new indication opens a previously unanticipated commercial pathway for NRX-101.

Building a Neuroplastic Therapy Ecosystem with neurocare

In January, NRXP announced a joint initiative with neurocare Group AG to create a nationwide network of integrated neuroplastic therapy clinics targeting depression, PTSD, and other serious mental health disorders.

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The model combines:

• TMS
• Ketamine and other neuroplastic drugs
• Hyperbaric oxygen therapy
• Psychotherapy

The rollout will leverage:

• neurocare's existing clinic footprint
• HOPE Therapeutics clinics
• 400+ Apollo® TMS machines already deployed nationwide

Early pilot programs—particularly among first responders with PTSD and depression—have demonstrated exceptionally high remission rates, positioning NRXP at the intersection of drug development and scalable clinical delivery.

A Clean Balance Sheet and Analyst Validation

In December, NRXP eliminated 100% of its balance-sheet debt, converting $5.4 million into equity with no additional warrants—a notable reset that strengthens the company's financial footing ahead of key regulatory milestones.

Adding to investor confidence, D. Boral Capital issued a Buy rating with a $34 price target, citing NRXP's pipeline breadth, regulatory momentum, and differentiated mental health strategy.

The Bottom Line

NRx Pharmaceuticals stands out in a crowded biotech landscape by targeting:

• One of the most urgent unmet needs in medicine
• With unprecedented real-world clinical data
• Multiple FDA pathways (Fast Track, ANDA, Breakthrough Therapy)
• A growing neuroplastic therapy infrastructure
• And a now debt-free balance sheet

As regulatory submissions advance and clinical integration expands, NRXP may be approaching an inflection point—one with the potential to redefine how suicidal depression and treatment-resistant mental illness are treated in the U.S.

Ticker: N A S D A Q: NRXP
More Information:

• https://www.nrxpharma.com/
• https://compasslivemedia.com/case-study/nrx-pharmaceuticals/

For more information:
NRx Pharmaceuticals, Inc. (N A S D A Q: NRXP)
Website: www.nrxpharma.com
Media Contact: Matthew Duffy, Chief Business Officer
Email: mduffy@nrxpharma.com | Phone: (484) 254-6134

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