The Californer - Revenue Expansion, Regulatory Momentum, and a Leadership Position in the 0 Million Suicidal Depression: NRx Pharmaceuticals (N A S D A Q: NRXP)

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$NRXP Has Manufactured Multiple Commercial Lots of NRX-100 and KETAFREE™ with a Shelf Life of Three Years.

MIAMI - Californer -- NRx Pharmaceuticals, Inc. (N A S D A Q: NRXP) is rapidly emerging as one of the most compelling growth stories in mental-health therapeutics. With three revenue-generating treatment facilities now operating in Florida—and six expected by year-end—the company is entering 2026 with accelerating clinical operations, expanding market share, and advancing two FDA-directed regulatory pathways for ketamine-based therapeutics aimed at suicidal depression, one of the largest unmet needs in mental health.

Backed by strong clinical data, FDA Fast Track designations, and third-party revenue projections, NRXP appears positioned to capitalize on a rapidly expanding U.S. ketamine market currently estimated at $750 million, projected to reach $3.35 billion globally by 2034.

Adding to investor enthusiasm, analyst D. Boral issued a Buy rating and a $34 price target, citing NRXP's accelerating execution and diversified commercialization strategy.

A Mission Targeting One of America's Most Pressing Health Crises

More than 13 million Americans seriously consider suicide each year (CDC). NRXP is developing next-generation therapeutics aimed directly at this crisis through its NMDA-based drug platform:

Key Pipeline Assets

NRX-100 (IV Ketamine):

FDA Fast Track designation for suicidal ideation in depression, including bipolar depression.
Multiple commercial lots produced with three-year shelf life stability.
NDA submission expected in Q4 2025, supported by real-world patient data from more than 60,000 IV ketamine cases.

KETAFREE™ (preservative-free ketamine):

Pursuing approval via an ANDA (generic) pathway.
Recently received supportive FDA correspondence confirming no major deficiencies and on track for a Q2 2026 GDUFA date.
Addresses a ketamine market worth ~$750 million annually.

NRX-101 (D-cycloserine + lurasidone):

FDA-designated Investigational Breakthrough Therapy.
Targets suicidal treatment-resistant bipolar depression, chronic pain, and potential utility in complicated UTIs.
New real-world data suggest its active ingredient doubles the effectiveness of TMS—a potential major indication expansion.

NRXP is partnered with Alvogen Pharmaceuticals for the development and commercialization of NRX-101.

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A Dual-Path Strategy for NRX-100: Innovative and Generic Market Entry

NRXP's regulatory strategy is unique: it is simultaneously pursuing both an innovative NDA pathway and a generic ANDA pathway for NRX-100 and KETAFREE™.

This creates two powerful value drivers:

1. Innovative NDA for Suicidal Depression

Expected completion: Q4 2025.
Includes comparative real-world data showing IV ketamine may have faster onset and greater effect than intranasal S-ketamine.
NRXP has applied for a Commissioner's National Priority Voucher, which could accelerate FDA review.

2. ANDA for KETAFREE™ (Generic Ketamine)

Re-filed after FDA approved NRXP's Suitability Petition for its preservative-free formulation.
Supportive FDA feedback in November 2025 indicated no significant deficiencies.
A Citizen Petition filed to remove toxic preservative benzethonium chloride from ketamine products could reshape the competitive landscape.

With commercial lots already manufactured, NRXP is positioned for a swift commercial rollout upon approval.

HOPE Clinics: Expanding Revenue Footprint Across Florida

NRXP's HOPE Therapeutics subsidiary is advancing a scalable clinic model for ketamine and advanced TMS-based interventions.

Current & Expected Expansion

3 operational facilities in Florida
6 additional facilities planned by year-end

These facilities support:

NRX-100 Expanded Access Program
Ketamine-based clinical services
ONE-D single-day TMS depression treatments
Veterans, first responders, and active-duty military populations

Management expects increased revenue contributions from clinical operations through 2026.

Breakthrough ONE-D: First-in-Florida Deployment with Ampa Health

In November, NRXP launched patient treatment using Ampa Health's ONE-D protocol—a groundbreaking approach reporting:

87% response rate
72% remission
Achieved in one day, instead of traditional 90-day TMS schedules

ONE-D combines:

Ampa's FDA-cleared TMS device
D-cycloserine (NRX-101 active ingredient)
Lisdexamfetamine

ONE-D is being deployed at HOPE clinics in Sarasota, Naples, and Fort Myers, with additional locations coming online in 2025.

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This marks a major competitive differentiator for NRXP in the mental-health treatment sector.

Financial Position: Capital Secured Through July 2026

NRXP reported securing sufficient operating capital to support its drug development programs through July 2026, complementing increasing clinical revenues.

Third-quarter results (released November 17, 2025) highlighted:

Progress across all clinical and regulatory objectives
Expanded Fast Track designation for NRX-100
EU and NIH data enhancing regulatory strategy
Growth of the HOPE facility platform
Enhanced IP and formulation positioning

The full Q3 update and webcast are available on the NRXP investor relations site.

High-Value Licensing Opportunity

NRXP has accepted non-binding potential terms from an international pharmaceutical partner for the licensing and distribution of NRX-100. Terms include:

Over $300 million in milestone payments
Tiered double-digit royalties

If finalized, this could represent a transformative revenue opportunity for the company.

Investment Outlook

With:

Multiple clinical catalysts approaching
Two regulatory pathways advancing for NRX-100
FDA Breakthrough Therapy designations
National leadership in cutting-edge TMS + D-cycloserine therapy
Increasing real-world data support
A growing network of revenue-producing treatment centers
Newly manufactured commercial drug supply
And a strong capital runway

NRx Pharmaceuticals is attracting increased attention from both institutional and retail investors.

The recent $34 price target from D. Boral underscores growing confidence in NRXP's ability to execute on a scalable, high-margin strategy targeting one of the most underserved and urgent areas of mental health.

For More Information

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

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