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NRx completes manufacturing validation for preservative-free ketamine

Mon, 19 Oct 2026 08:32:37 -0400

NRx Pharmaceuticals (NASDAQ: NRXP) announced the completion of three commercial process validation lots of preservative-free ketamine, manufactured in compliance with FDA Good Manufacturing Practices, according to a company press release.

The validation was completed ahead of the November 10, 2026 GDUFA goal date for the company's Abbreviated New Drug Application. Process validation is the final manufacturing step required to demonstrate compliance with FDA Good Manufacturing Practices.

NRx also reported two-year room-temperature stability data on the product, showing no deterioration in purity, potency, or sterility. The company said it believes the data support a labeled shelf life of three years or longer, though

NRx Pharmaceuticals (Nasdaq:NRXP) Announces Completion of Manufacturing Process Validation and Two-Year Stability of Preservative-Free Ketamine

Mon, 19 Oct 2026 08:30:00 -0400

In advance of November 10, 2026 GDUFA goal date, three commercial lots of Preservative-Free Ketamine have been successfully manufactured in compliance with “Process Validation” required under FDA “Good Manufacturing Practices” (GMP).
NRx has additionally received two year stability data consistent with projected room-temperature stability to three years and beyond with no need for toxic preservatives.
Commercially-releasable drug supply is now on hand pending ANDA approval for this drug-shortage product.

WILMINGTON, N.C., Oct. 19, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP, “NRx” or “the Company”), a clinical-stage biopharmaceutical company developing therapeutics based on

NRx Pharmaceuticals (Nasdaq:NRXP) Announces Completion of Manufacturing Process Validation and Two-Year Stability of Preservative-Free Ketamine

Mon, 19 Oct 2026 08:30:00 -0400

In advance of November 10, 2026 GDUFA goal date, three commercial lots of Preservative-Free Ketamine have been successfully manufactured in compliance with “Process Validation” required under FDA “Good Manufacturing Practices” (GMP).
NRx has additionally received two year stability data consistent with projected room-temperature stability to three years and beyond with no need for toxic preservatives.
Commercially-releasable drug supply is now on hand pending ANDA approval for this drug-shortage product.

Form 8-K NRX Pharmaceuticals, For: Oct 16

Fri, 16 Oct 2026 17:16:00 -0400

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FDA sends minor labeling comments to NRx for ketamine ANDA

Thu, 15 Oct 2026 08:28:13 -0400

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) announced it received a Discipline Review Letter from the U.S. Food and Drug Administration requesting minor changes to the submitted label for its preservative-free ketamine product, according to a company statement.

The FDA classified all requested changes as "minor" and asked NRx to prepare and submit sample labeling using the proposed proprietary product name, which remains under FDA review. The requests come ahead of the November 10, 2026, Abbreviated New Drug Application (ANDA) GDUFA goal date.

NRx said it is currently completing final manufacturing process validation runs to meet product launch requirements.

"We at NRx deeply appreciate the

NRx Pharmaceuticals Announces Receipt of FDA Labeling Review Letter for Preservative-Free Ketamine

Thu, 15 Oct 2026 08:27:00 -0400

In advance of November 10, 2026, GDUFA goal date, all requested changes were classified as “MINOR.”
NRx was requested to prepare and submit labels with the proprietary name currently under review by FDA.
NRx is currently completing final manufacturing Process Validation Runs to comply with product launch requirements.

WILMINGTON, Del., Oct. 15, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP, “NRx” or “the Company”), a biopharmaceutical company that focuses on neuroplastic therapies for depression, PTSD, and related conditions, today announces the receipt of a “DISCIPLINE REVIEW LETTER” from the US Food and Drug Administration

NRx Pharmaceuticals Announces Receipt of FDA Labeling Review Letter for Preservative-Free Ketamine

Thu, 15 Oct 2026 08:27:00 -0400

In advance of November 10, 2026, GDUFA goal date, all requested changes were classified as “MINOR.”
NRx was requested to prepare and submit labels with the proprietary name currently under review by FDA.
NRx is currently completing final manufacturing Process Validation Runs to comply with product launch requirements.

Form 8-K NRX Pharmaceuticals, For: Sep 29

Mon, 05 Oct 2026 17:01:00 -0400

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NRx Defense wins $11M DARPA contract for depression treatment trial

Wed, 30 Sep 2026 07:00:26 -0400

NRx Defense Systems, a subsidiary of NRx Pharmaceuticals (NASDAQ: NRXP), has been awarded an $11.17 million contract from the Defense Advanced Research Projects Agency (DARPA) to evaluate a single-day treatment protocol combining robotic transcranial magnetic stimulation (TMS) with the investigational drug NRX-101 for treatment-resistant depression.

The clinical trial, called SPARC-TMS (Synaptic Plasticity Augmented Rapid Circuit Stimulation), has received FDA approval to begin enrolling patients. It will be conducted at Harvard Medical School's McLean Hospital, Arizona State University, and HOPE Therapeutics, with plans to expand to military hospitals.

The trial will test whether a full course of TMS delivered in a single outpatient

NRx Defense Systems, an NRx Company (Nasdaq:NRXP) Awarded $11 Million Dollar DARPA Prime Contract to Evaluate Robotic Magnetic Stimulation in conjunction with NRX-101 for Treatment of Resistant Depres

Wed, 30 Sep 2026 07:00:00 -0400

DARPA states that the program, if successful, will fundamentally change the Standard of Care for Treatment Resistant Depression. The Military has recognized that current treatments for depression are not deployable in operational military settings.
The SPARC-TMS Single Day treatment protocol, which involves the use of Robotic Neuronavigated Transcranial Magnetic Stimulation (TMS) augmented by NRx’s neuroplastic investigational drug NRX-101, is based on a recently completed randomized-controlled trial funded by DARPA and published real world findings of 91% treatment response and 69% remission at 3 months post treatment with traditional TMS + D-cycloserine (an active ingredient of NRX-101).
If the

NRx Defense Systems, an NRx Company (Nasdaq:NRXP) Awarded $11 Million Dollar DARPA Prime Contract to Evaluate Robotic Magnetic Stimulation in conjunction with NRX-101 for Treatment of Resistant Depres

Wed, 30 Sep 2026 07:00:00 -0400

DARPA states that the program, if successful, will fundamentally change the Standard of Care for Treatment Resistant Depression. The Military has recognized that current treatments for depression are not deployable in operational military settings.
The SPARC-TMS Single Day treatment protocol, which involves the use of Robotic Neuronavigated Transcranial Magnetic Stimulation (TMS) augmented by NRx’s neuroplastic investigational drug NRX-101, is based on a recently completed randomized-controlled trial funded by DARPA and published real world findings of 91% treatment response and 69% remission at 3 months post treatment with traditional TMS + D-cycloserine (an active ingredient of NRX-101).
If the

Form 8-K NRX Pharmaceuticals, For: Sep 15

Wed, 16 Sep 2026 06:02:00 -0400

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FDA reclassifies NRx Pharmaceuticals ketamine application amendment

Tue, 15 Sep 2026 15:11:44 -0400

NRx Pharmaceuticals (NASDAQ: NRXP) announced that the FDA has reclassified an amendment to its Abbreviated New Drug Application (ANDA) for preservative-free ketamine from a Major Amendment to a Minor Amendment.

The FDA's Office of Generic Drugs communicated the reclassification in writing, noting that the amendment will not require a substantial expenditure of FDA resources. The agency revised the Generic Drugs User Fee Act (GDUFA) goal date to November 10, 2026.

"On behalf of our patients and our shareholders, we are deeply appreciative of the speed with which FDA's leadership has moved to advance the approval process of this strategic, drug shortage product,"

NRx Pharmaceuticals (Nasdaq: NRXP) Reports Update from the FDA Revising Previous Major Amendment to a Minor Amendment for Preservative-free Ketamine

Tue, 15 Sep 2026 15:11:00 -0400

Abbreviated New Drug Application (ANDA) Amendment related to the drug vial for preservative-free ketamine has been reclassified from a Major Amendment to a Minor Amendment.
FDA has revised the Generic Drugs User Fee Act (GDUFA) Goal Date to November 10, 2026.

WILMINGTON, Del., Sept. 15, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx" or the "Company"), a clinical-stage biopharmaceutical company, today announced that it has received a written communication from the Director of Regulatory Operations of the FDA Office of Generic Drugs advising the Company that the amendment to its Abbreviated New Drug

NRx Pharmaceuticals (Nasdaq: NRXP) Reports Update from the FDA Revising Previous Major Amendment to a Minor Amendment for Preservative-free Ketamine

Tue, 15 Sep 2026 15:11:00 -0400

Abbreviated New Drug Application (ANDA) Amendment related to the drug vial for preservative-free ketamine has been reclassified from a Major Amendment to a Minor Amendment.
FDA has revised the Generic Drugs User Fee Act (GDUFA) Goal Date to November 10, 2026.

Form 8-K NRX Pharmaceuticals, For: Sep 08

Mon, 14 Sep 2026 08:00:00 -0400

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GeNeuro wins European patent for ALS drug candidate GNK-301

Mon, 14 Sep 2026 07:19:23 -0400

GeNeuro, Inc., a subsidiary of NRx Pharmaceuticals, Inc. (NASDAQ: NRXP), announced it has been awarded a European patent (EP 3 570 878 B1) for GNK-301, a monoclonal antibody drug candidate targeting Amyotrophic Lateral Sclerosis (ALS).

The patent covers an antibody developed jointly by GeNeuro and scientists at the U.S. National Institute of Neurological Disorders and Stroke (NINDS) under a Cooperative Research and Development Agreement. Two U.S. patents (10,723,787 and 10,981,977) for the same invention were previously granted. The patents are co-owned by GeNeuro and the U.S. Department of Health and Human Services.

The drug candidate targets the envelope protein of Human Endogenous

GeNeuro, Inc., an NRx Company (Nasdaq:NRXP) is awarded European Patent Rights for GNK-301, a novel drug candidate to treat Amyotrophic Lateral Sclerosis (ALS)

Mon, 14 Sep 2026 07:00:00 -0400

Invention is based on the discovery that ALS may be caused by reactivation of Human Endogenous Retrovirus K (HERV K) Envelope protein (K Env), already coded in the “dark genome” of all people.

K Env is found in the spinal fluid of more than 75% of people with ALS and has been shown to produce the neurodegenerative findings of ALS in experimental animals and human neuron cells.

The patent (EP 3 570 878 B1) covers a novel monoclonal antibody (GNK-301) developed by GeNeuro and scientists at the US National Institute of Neurological Disorders and Stroke

GeNeuro, Inc., an NRx Company (Nasdaq:NRXP) is awarded European Patent Rights for GNK-301, a novel drug candidate to treat Amyotrophic Lateral Sclerosis (ALS)

Mon, 14 Sep 2026 07:00:00 -0400

Invention is based on the discovery that ALS may be caused by reactivation of Human Endogenous Retrovirus K (HERV K) Envelope protein (K Env), already coded in the “dark genome” of all people.

K Env is found in the spinal fluid of more than 75% of people with ALS and has been shown to produce the neurodegenerative findings of ALS in experimental animals and human neuron cells.

The patent (EP 3 570 878 B1) covers a novel monoclonal antibody (GNK-301) developed by GeNeuro and scientists at the US National Institute of Neurological Disorders and Stroke

NRx subsidiary HOPE begins training on FDA-cleared robotic TMS system

Fri, 11 Sep 2026 07:00:50 -0400

NRx Pharmaceuticals (Nasdaq: NRXP) announced that its subsidiary, HOPE Therapeutics, Inc., is training clinical staff on Zeta Surgical's FDA-cleared Zeta TMS Robotic System, ahead of deployment at HOPE's Florida clinics.

HOPE claims to be the first interventional psychiatry network to deploy the system, which received FDA 510(k) clearance in July 2026. Staff are completing orientation at Zeta Surgical's headquarters in Boston. The robotic system uses AI-driven software to adjust a TMS coil in real time with submillimeter precision via a robotic arm originally approved for neurosurgery.

The deployment builds on a step HOPE took in June 2026, when it became what it

NRx Pharmaceuticals (Nasdaq: NRXP) Subsidiary HOPE Therapeutics Begins Training and Deployment of Zeta Surgical's FDA-Cleared Robotic TMS System

Fri, 11 Sep 2026 07:00:00 -0400

HOPE is the first Interventional Psychiatry network to deploy Zeta Surgical's newly FDA-cleared TMS Robotic System; the HOPE clinical team is completing orientation and training at Zeta Surgical's headquarters in Boston ahead of deployment in HOPE's Florida clinics
The Zeta TMS Robotic System's AI-driven software adjusts the TMS coil in real time with submillimeter precision, building on the Zeta TMS Navigation System HOPE implemented earlier this summer
Deployment supports SPARC-TMS, NRx's trial of NRX-101 with robotic TMS, for which NRx is initiating a project for the military, in partnership with Harvard McClean Hospital.
NRx Pharmaceuticals is participating in

NRx Pharmaceuticals (Nasdaq: NRXP) Subsidiary HOPE Therapeutics Begins Training and Deployment of Zeta Surgical's FDA-Cleared Robotic TMS System

Fri, 11 Sep 2026 07:00:00 -0400

HOPE is the first Interventional Psychiatry network to deploy Zeta Surgical's newly FDA-cleared TMS Robotic System; the HOPE clinical team is completing orientation and training at Zeta Surgical's headquarters in Boston ahead of deployment in HOPE's Florida clinics
The Zeta TMS Robotic System's AI-driven software adjusts the TMS coil in real time with submillimeter precision, building on the Zeta TMS Navigation System HOPE implemented earlier this summer
Deployment supports SPARC-TMS, NRx's trial of NRX-101 with robotic TMS, for which NRx is initiating a project for the military, in partnership with Harvard McClean Hospital.
NRx Pharmaceuticals is participating in

NRx Pharmaceuticals (Nasdaq: NRXP) Subsidiary HOPE Therapeutics Begins Training and Deployment of Zeta Surgical's FDA-Cleared Robotic TMS System

Fri, 11 Sep 2026 07:00:00 -0400

HOPE is the first Interventional Psychiatry network to deploy Zeta Surgical's newly FDA-cleared TMS Robotic System; the HOPE clinical team is completing orientation and training at Zeta Surgical's headquarters in Boston ahead of deployment in HOPE's Florida clinics
The Zeta TMS Robotic System's AI-driven software adjusts the TMS coil in real time with submillimeter precision, building on the Zeta TMS Navigation System HOPE implemented earlier this summer
Deployment supports SPARC-TMS, NRx's trial of NRX-101 with robotic TMS, for which NRx is initiating a project for the military, in partnership with Harvard McClean Hospital.
NRx Pharmaceuticals is participating in

NRx Pharmaceuticals (Nasdaq: NRXP) Subsidiary HOPE Therapeutics Begins Training and Deployment of Zeta Surgical's FDA-Cleared Robotic TMS System

Fri, 11 Sep 2026 07:00:00 -0400

HOPE is the first Interventional Psychiatry network to deploy Zeta Surgical's newly FDA-cleared TMS Robotic System; the HOPE clinical team is completing orientation and training at Zeta Surgical's headquarters in Boston ahead of deployment in HOPE's Florida clinics
The Zeta TMS Robotic System's AI-driven software adjusts the TMS coil in real time with submillimeter precision, building on the Zeta TMS Navigation System HOPE implemented earlier this summer
Deployment supports SPARC-TMS, NRx's trial of NRX-101 with robotic TMS, for which NRx is initiating a project for the military, in partnership with Harvard McClean Hospital.
NRx Pharmaceuticals is participating in

NRx Pharmaceuticals to Participate in Upcoming Investor Conferences

Tue, 08 Sep 2026 07:00:00 -0400

WILMINGTON, Del., Sept. 08, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals" or the "Company"), a clinical-stage biopharmaceutical company, today announced that the management team will participate in three upcoming investor conferences in September 2026.

Moody Capital Solutions 2026 Disruptive Growth & Life Sciences Conference
Company Presentation
Presenter: Jonathan Javitt, M.D., M.P.H., Founder, Chairman and Chief Executive Officer of NRx Pharmaceuticals
Location: New York, New York
Date: September 9, 2026
Presentation Time: 9:35-9:55 a.m. ET

2026 Cantor Global Healthcare Conference
Fireside Chat
Presenter: Jonathan Javitt, M.D., M.P.H., Founder, Chairman and Chief Executive Officer