MIAMI - s4story -- Developing NRX-101, an FDA-Designated Investigational Breakthrough Therapy for Suicidal Treatment-Resistant Bipolar Depression and Chronic Pain.

Aiming to be the First FDA-Approved Medication to Treat Suicidal Depression

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

New Drug Application for Treatment of Suicidal Depression; Planned NDA for Accelerated Approval for Bipolar Depression in People at Risk of Akathisia.

Application to Uplist to NASDAQ Global Market from NASDAQ Capital Market

NRx Pharmaceuticals, Inc. (Stock Symbol: 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.

Intravenous ketamine is widely accepted as a standard of care for acute treatment of suicidal depression, in the absence of an FDA-labeled product; the only treatment currently approved by the FDA is electroconvulsive therapy (ECT).  According to the CDC, 3.8 million Americans make a plan for suicide each year.  This represents a $3-5 billion market at expected pricing. Based on the data in the trials referenced above, the Company's regulatory counsel encouraged the Company to file an NDA for suicidal depression for NRX-100.

In a January 2025 report, respected investment analysis firm D. Boral Capital assigned NRXP a $31 Price Target. The full report may be viewed at this link: https://www.nrxpharma.com/wp-content/uploads/2025/01/HOPE-Therapeutics-Advances-With-Kadima.pdf.

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Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update

On March 17^th NRXP announced its financial results for the quarter and year ended December 31, 2024, and provided a business update.  The announcement included the following key highlights:

NRXP initiated filing of a New Drug Application ("NDA") to the FDA for NRX-100 (IV Ketamine) for the treatment of Suicidal Depression; planned filing of an NDA for Accelerated Approval under Breakthrough Designation and Priority Review of NRX-101 for the treatment of bipolar depression in people at risk of akathisia. Both have anticipated PDUFA dates prior to December 31, 2025

NRXP has accepted non-binding potential terms from a commercial pharmaceutical company to license and distribute NRX-100, providing over $300 million in milestones plus tiered double-digit royalties based on net sales

NRXP retained a leading regulatory law firm to file a citizen's petition with the US Food and Drug Administration ("FDA") to remove benzethonium chloride – a toxic preservative -- from presentations of ketamine intended for intravenous use; planned 2Q25 filing of an Abbreviated New Drug Application ("ANDA") for the use of preservative-free ketamine in all current indications

Wholly owned subsidiary HOPE Therapeutics, signed non-binding letters of intent to acquire three precision psychiatry centers and is currently completing financial due diligence and definitive agreements. Currently negotiating the terms for the acquisition of six additional centers

The HOPE acquisitions are planned to form the foundation for a national network offering interventional psychiatry services to treat suicidal depression, post-traumatic stress disorder ("PTSD") and related conditions

NRXP received and negotiating a term sheet from a publicly-traded strategic investor currently engaged in manufacturing Transcranial Magnetic Stimulation ("TMS") devices to provide capital in support of expansion of further HOPE clinic acquisitions.

NRXP has engaged BTIG as financial advisor for clinic acquisition and capital formation; leading global financial services firm specializing in investment banking, institutional trading, research, and related brokerage services for strategic growth opportunities.

NRXP regained compliance with the NASDAQ market value of listed securities ("MVLS") requirement.

Substantially reduced operating costs compared to prior year

Management continues to forecast, although no assurances can be given, profitability on a forward-looking run-rate basis by year end 2025

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NRXP filed Module 3 (manufacturing) of its New Drug Application ("NDA") for NRX-100 (preservative-free sterile IV ketamine) in a tamper-resistant, diversion resistant packaging presentation in the fourth quarter of 2024. NRX-100 was previously granted Fast Track Designation by FDA in combination with use of NRX-101. Ketamine efficacy data from four clinical trials are intended to support the filing. Three manufacturing lots are now complete, with filed stability data suitable for shelf life exceeding two years at room temperature. The anticipated PDUFA date for this NDA is prior to December 31, 2025.

NRX-100 is poised to address the over $3 billion Suicidal Depression market in the US.

NRXP has accepted non-binding potential terms from a commercial pharmaceutical company to license and distribute NRX-100 (preservative-free IV ketamine) that provides for over $300 million in potential milestones plus a tiered double-digit royalty, subject to further due diligence and finalized agreement.

NRXP announced its intention to file an NDA for Accelerated Approval under Breakthrough Designation and Priority Review of NRX-101 for the treatment of bipolar depression in people at risk of akathisia, based on the Phase 2b/3 and STABIL-B data. Three manufacturing lots are now complete with more than 12 months of room temperature shelf-stability. The anticipated PDUFA date for this application is prior to December 31, 2025.

NRXP estimates that the market for the initial indication is over $2 billion, while the broad bipolar market could exceed $5 billion.

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. (Stock Symbol: 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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