MIAMI - s4story -- A $750 million global market for preservative-free IV ketamine is now within reach for NRx Pharmaceuticals, Inc. (N A S D A Q: NRXP), following the company's announcement that the U.S. Food and Drug Administration (FDA) has formally accepted its Abbreviated New Drug Application (ANDA) for KETAFREE™, the first known preservative-free ketamine formulation. The FDA has deemed the application "substantially complete," assigning a GDUFA target action date of July 29, 2026—a critical milestone that positions NRx for potential entry into a high-demand therapeutic market.

The FDA submission comes as independent analyst D. Boral issues a Buy rating with a $34 price target, citing NRx's maturing regulatory position, expanding revenue-generating operations, and strong clinical catalysts across its NMDA-focused drug platform.

A Transformative Solution for a Critical Mental Health Crisis

More than 13 million Americans contemplate suicide each year, according to the CDC. Current treatment options are limited, and many lack evidence of rapid antisuicidal benefit. NRx's pipeline directly targets this gap:

NRX-100 (IV Ketamine)

• Awarded Fast Track Designation by the FDA for reducing suicidal ideation in depression, including bipolar depression.
• Supported by results from well-controlled NIH-sponsored studies as well as newly licensed data from French health authorities.
• Being pursued via an NDA, expected to be completed in Q4 2025, supported by real-world data from 60,000 IV ketamine patients versus 6,000 intranasal S-ketamine patients. Early analyses suggest faster onset and greater impact compared to nasal formulations.

NRX-101 (D-Cycloserine + Lurasidone)

• An investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression.
• New real-world evidence shows D-cycloserine may double the effectiveness of TMS, opening additional market opportunities in treatment-resistant depression and chronic pain.

KETAFREE™: A Strategic ANDA Pathway and Major Competitive Advantage

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The global generic ketamine market is estimated at $750 million annually. Nearly all existing products contain benzethonium chloride (BZT)—a preservative banned from topical antiseptics and not recognized as safe by the FDA.

NRx's preservative-free KETAFREE™ directly addresses this safety concern.
The company has:

• Applied for KETAFREE™ as a proprietary product name
• Manufactured initial registration lots and prepared capacity for 1 million vials per month
• Filed a Citizen Petition urging removal of BZT from all U.S. ketamine products
• Positioned manufacturing entirely within the United States, aligning with national efforts to secure domestic drug supply chains

KETAFREE™ is strategically separate from the company's innovative NRX-100 program, enabling two simultaneous FDA pathways:

1. ANDA approval (generic route) for rapid commercialization
2. Fast Track NDA approval (innovative route) for suicidal depression—an unmet medical need with multibillion-dollar potential

Expanding Commercial Footprint: HOPE Therapeutics Clinics

2025 marks NRx's entry into revenue-generating operations through its HOPE Therapeutics subsidiary.
The company currently operates three clinics in Florida, with six more expected by year-end, targeting treatment-resistant psychiatric conditions, chronic pain, and military/veteran mental health.

NRx also launched Florida's first deployment of the ONE-D protocol with Ampa Health, a groundbreaking, single-day treatment approach utilizing an FDA-cleared device. Peer-reviewed results of the protocol show up to 87% response and 72% remission rates, signaling a disruptive new pathway for addressing treatment-resistant depression.

Capital Secured Through July 2026—With Additional Upside from Operating Revenue

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NRx reports that it has secured operating capital for ongoing development through July 2026, covering the critical period leading up to the FDA's action date on the KETAFREE™ ANDA submission. With revenue now emerging from HOPE clinics and an expanding patient base, the company expects increasing non-dilutive revenue contribution.

Strategic Partnerships Strengthening Commercial Potential

NRx has partnered with Alvogen Pharmaceuticals, leveraging Alvogen's global reach to support development and commercialization of NRX-101 for suicidal bipolar depression. Additional potential indications include non-opioid chronic pain management and treatment of complicated UTIs.

A Pivotal Moment for NRXP Investors

Between its dual-path FDA strategy, real-world data advantages, strong analyst sentiment, and rapidly expanding commercial infrastructure, investors now see NRx Pharmaceuticals reaching an inflection point:

• ✔ FDA-validated ANDA submission for KETAFREE™
• ✔ Fast Track designation for NRX-100
• ✔ Breakthrough Therapy designation for NRX-101
• ✔ $34 analyst price target from D. Boral
• ✔ Manufacturing scale ready for 1M vials/month
• ✔ Real-world ketamine data fueling NDA advancement
• ✔ Nationwide clinic expansion underway

With updated clinical results, strong regulatory momentum, and multiple near-term catalysts, NRx is uniquely positioned to become a leader in next-generation therapies for suicidal depression—a market with urgent unmet need and substantial commercial potential.

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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