More Than 1 Million Suicidal Depression Cases Per Year May Be Treated by 2030 via New Indication for Augmentation of Transcranial Magnetic Stimulation: NRx Pharmaceuticals, Inc. (Nasdaq: NRXP)

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$NRXP Also Reports Its Superior Preservative-Free IV Ketamine Now Submitted for FDA Abbreviated New Drug Application

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

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

* D. Boral Analyst Report on NRXP $34 Price Target.

* New Pipeline Indication for Augmentation of Transcranial Magnetic Stimulation.

* Abbreviated New Drug Application (ANDA) is "Substantially Complete" and Received for FDA Review. Assigned Goal Date is July 29, 2026.

* Applied for Use of KETAFREE Trademark as a Proprietary Product Name as First Preservative-Free Ketamine Formulation.

* Current Worldwide Generic Ketamine Market Estimated at $750 Million Per Year.

* Manufactured Initial Registration Lots of KETAFREE Trademark and Prepared to Scale Manufacturing to 1 Million Vials Per Month.

* Citizen Petition filed with the FDA Seeking Removal of Benzethonium Chloride Preservative from All Forms of Ketamine Sold in the United States.

* Three Revenue-Generating Facilities in Florida and Expects Six More by Year-End for HOPE Subsidiary Clinics.

* Secured Operating Capital for Drug Development Through July 2026. Expecting Increased Revenue from Clinical Operations.

* Received FDA Grant of Fast Track Designation for NRX-100 in Treatment of Suicidal Ideation in Patients with Depression, Including Bipolar Depression.

NRx Pharmaceuticals, Inc. (Nasdaq: 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.

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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.

D. Boral has issued an Analyst Report on NRXP with a Buy and $34 Price Target. The full report may be accessed at this direct link: https://www.nrxpharma.com/wp-content/uploads/2025/11/HOPE-Therapeutics-NRXP-Executes-Florida-Roll-out-of-Ampa-O.pdf

New NRX-101 Pipeline Indication for Augmentation of Transcranial Magnetic Stimulation

On December 3rd NRXP announced that it has amended its Investigational New Drug filing for NRX-101 (D-cycloserine/lurasidone) to include its use in association with Transcranial Magnetic Stimulation (TMS) for the treatment of depression, including suicidal depression.

In the third quarter, NRXP identified a promising new indication for NRX-101 that potentially offers rapid path to commercialization for this Breakthrough Therapy-designated drug. Recent evidence suggests that NRX-101 may confer a significant added advantage to the clinical results of Transcranial Magnetic Stimulation.

On November 4th Real World Data were presented in conjunction with use of a modern Theta Burst FDA-cleared TMS device and a one day TMS protocol, combined with a single administration of oral DCS. The authors reported 87% clinical response and 72% remission manifesting at 6 weeks after a single day of treatment on the Hamilton Depression Rating Scale with similar findings on other standard test measures.

In addition to containing D-cycloserine, NRX-101 contains a low dose of lurasidone, a medicine already approved for treatment of depression and known to have anti-hallucinatory properties. D-cycloserine by itself is well known to have a low, but measurable potential for inducing low-grade hallucinations, resulting in a labeled contraindication against the use of Seromycin Registered (D-cycloserine) in patients with depression. This contraindication originally led the founders of NRXP to develop and patent the NRX-101 drug combination, which has now obtained composition of matter patent protection in all major jurisdictions.

NRXP believes that the clinical benefit demonstrated in the published trials can be demonstrated in a well-controlled trials of approximately 120 participants. NRXP is in partnership discussion with manufacturers of currently-marketed TMS devices to configure a joint clinical trial that will lead to drug registration and augmentation of FDA labeling of currently-approved TMS devices.

Given current trends, NRXP expects that more than 1 million Americans per year may be treated with TMS by the year 2030, creating a substantial new potential market for NRX-101 not previously anticipated. As required by law for Breakthrough Therapy drugs such as NRX-101, NRXP has published an Expanded Access policy for this medication.

US Food and Drug Administration (FDA) Receipt of ANDA for KETAFREE Trademark , a Preservative-Free IV Ketamine

On December 2nd NRXP announced that the U.S. Food and Drug Administration (FDA) has received the Company's Abbreviated New Drug Application (ANDA) for KETAFREE Trademark , a preservative-free intravenous ketamine formulation. The acknowledgement letter states that the FDA has "made a threshold determination that this NRXP ANDA is substantially complete" and issued a goal date of July 29, 2026 for completion of the final review with potential marketing approval.

Current ketamine products are typically supplied in multi-dose vials that contain a preservative called Benzethonium Chloride (BZT) that is not recognized as safe by FDA and banned from hand cleansers and topical antiseptics.

The current MAHA initiatives have called for review and removal of toxic substances from foods, drugs, and vaccines and NRXP KETAFREE Trademark , designed to align with those priorities, is intended for all currently approved ketamine indications and is manufactured in the United States, supporting national efforts to strengthen the domestic supply of critical medicines.

KETAFREE Trademark is separate from the NRXP New Drug Application for NRX-100, which is being developed as an innovative drug for the treatment of suicidal depression and has received Fast Track designation from the FDA.

NRXP continues to advance other elements of its pipeline and its development of HOPE Therapeutics clinics, a report being presented at the December 3rd Noble Securities NOBLECON conference and available on the Company's website.

Third Quarter 2025 Corporate Update

On November 17th NRXP announced financial results for the quarter ended September 30, 2025, and provided a corporate update.

Dr. Jonathan Javitt, CEO of NRXP stated, "In 2025 we have advanced each of our corporate objectives and entered into revenue-generating activity for the first time. For NRX-100 in suicidal depression, we received an expanded Fast Track designation, opened an Expanded Access program and enhanced our regulatory package. Additionally, FDA granted our Suitability Petition for a single patient, preservative free ketamine strength and we have received validation that our ANDA filing is on track with no major deficiencies. In parallel, the Real World Data demonstrating a doubling of antidepressant and antisuicidal effect of Transcranial Magnetic Stimulation (TMS) when D-cycloserine is added creates a new and significant indication for NRX-101 that has potential for approval, if confirmed in an additional phase 3 trial. For HOPE, we continue to execute on building our delivery platform of three active facilities in Florida, with three more planned by year-end. Dr. Rebecca Cohen and LTC Charles Paul, RN (US Army, Ret.) are assembling a network of best-in-class interventional psychiatrists to meet the needs of people, including active duty military, first responders, and veterans, across Florida and beyond."

Key Research and Development and Corporate Activities:NRXP is pursuing two paths to market for NRX-100: a distinct innovative pathway via a New Drug Application (NDA) under FDA Fast Track designation to develop NRX-100 for suicidal ideation in depression, including bipolar depression, and a generic pathway via an Abbreviated New Drug Application (ANDA) to supply a preservative-free ketamine (KETAFREE Trademark ) into the existing ketamine market.

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Recent correspondence from the FDA suggests that the latter pathway is on track for a Q2 2026 GDUFA date. The current generic ketamine market is estimated at approximately $750 million. By contrast, the innovative ketamine-based product SPRAVATO Registered is expected to generate over $1.6 billion in 2025 sales, although its labeling states that effectiveness in preventing suicide or reducing suicidal ideation has not been demonstrated. This highlights a differentiated opportunity for NRXP NRX-100, specifically in suicidal ideation. A New Drug Application ("NDA") for NRX-100 for suicidal depression, originally initiated during the fourth quarter of 2024, is expected to be completed in the fourth quarter 2025 with the addition of Real World Efficacy Data drawn from more than 60,000 patients treated for depression with intravenous ketamine compared to 6,000 patients treated with intranasal S-ketamine to be submitted as part of the NDA. An interim analysis drawn from the first 20,000 patients suggests that IV ketamine may have a more rapid onset of action and larger magnitude of effect than nasal S-ketamine. The Company has applied to receive a Commissioner's National Priority Voucher (CNPV), which could significantly reduce review time.

NRXP has now manufactured multiple commercial lots of NRX-100 and KETAFREE Trademark with ongoing stability data supporting a room temperature shelf life of three years.

Third Quarter 2025 Financial Results

NRXP third quarter 2025 financial results were released on November 17th via public disclosure media and on the Company's website at https://ir.nrxpharma.com/. NRXP management also hosted a conference call on the same day. A live webcast of the conference call will be available on the NRXP website at https://ir.nrxpharma.com/events [https://www.globenewswire.com/Tracker?data=72gxysve0Wq1-Bs6OdT1DLHm21KF0ok-ptcUKTVEHTMBcrA7rVTsgYsIbP4XFrSuMUwiPAWO4tMD2J00DHrZa_zO0okIYpM7tmkdq-mYINdCKwBUWYix1OtHxOYS7n1i].

For more information on $NRXP visit: https://www.nrxpharma.com/ [about:blank] and https://compasslivemedia.com/case-study/nrx-pharmaceuticals/

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