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

• Designed to Help Over 13 Million Americans who Seriously Consider Suicide Each Year (CDC).

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

• Type C Meeting with the FDA Demonstrates a Path to New Drug Application with Real World Data and Broader Proposed Indication for NRX-100 (ketamine).

• Presidential Initiative to Accelerate Approval of Psychedelic Medications to Treat Depression, PTSD, and Suicidality.

• Submitting a New Drug Application to Align the Labeling of Ketamine with its Use in Treating Depression and Suicidality.

• 2026 Q1 Financial Results Showed Significantly Improved Financial Status with Lower Net Loss vs Same Perion in 2025

• $6.7 Million in Cash and Cash Equivalents Sufficient to Support Operations Through 2026.

• NRXP Subsidiary HOPE Therapeutics Becomes First Commercial Site to Deploy Zeta Surgical's FDA-Cleared Zeta TMS Navigation System

• AI-Powered, Sub-Millimetric Image Guidance for Delivery of Transcranial Magnetic Stimulation (TMS) to Patients.

• Initiated First Commercial Manufacturing for Preservative Free Ketamine.

• President Trump Signed Executive Order to Accelerate Treatments for Mental illness on April 18, 2026 with Support for Psychedelic Medications.

• Robotic-Enabled Transcranial Magnetic Stimulation Combined with Neuroplastic Therapy for Military and First Responder Applications

• Anticipated FDA Approval of at Least One NRXP New Drug – Preservative Free Ketamine Under an ANDA—During Q3 2026.

• Published Results Have Shown 87% Clinical Response to Non-Invasive Transcranial Magnetic Stimulation with Neuroplastic Medications.

• Clinical Leadership by Physicians Trained at Harvard, Johns Hopkins, Georgetown, and Other Leading Universities.

• 70,000 Patient Data on Real World Use of Ketamine for Treatment of Suicidal Depression to be Submitted to the FDA in Support of NRX-100 Approval

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

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 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

NRXP Subsidiary HOPE Therapeutics Becomes First Commercial Site to Deploy Zeta Surgical's FDA-Cleared Zeta TMS Navigation System

On May 27th NRXP announced that its wholly-owned subsidiary, HOPE Therapeutics, Inc. has become the first commercial site to deploy Zeta Surgical's FDA-cleared Zeta TMS Navigation System. The system has been installed at HOPE's West Palm Beach, Florida clinic, where it will be used to deliver high-precision, image-guided Transcranial Magnetic Stimulation (TMS) for patients with Major Depressive Disorder and other neurological conditions.

The deployment complements NRXP broader interventional psychiatry platform, which includes ketamine and Spravato® delivery, TMS, Hyperbaric Oxygen Therapy, and other neuroplastic therapies. It also aligns with the NRXP clinical trial program of NRX-101 (oral D-cycloserine/lurasidone) in combination with robotic-enabled TMS for patients with depression and suicidality, which is planned to be conducted across a leading US academic teaching hospital, three NRXP HOPE Therapeutics clinics, and two military treatment facilities.

First Quarter 2026 Financial Results and Corporate Update

On May 18th NRXP announced financial results for the quarter ended March 31, 2026, and reviewed its latest key developments. The quarter was marked by continued progress advancing NRXP drug candidates toward commercialization, further development of the HOPE Therapeutics subsidiary, FDA acceptance of an IND for a federally-supported trial of NRX-101 as an adjunct to robotic Transcranial Magnetic Stimulation (TMS), and the pending acquisition of a Phase 2 monoclonal antibody portfolio targeting Human Endogenous Retroviruses (HERVs) implicated in Schizophrenia, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Autism, and Type 1 Diabetes.

For the quarter of 2026, NRXP reported an improved net loss of $1.4 million, versus a net loss of $5.5 million during the comparable quarter in 2025. The change was primarily related to the impact of certain fair value accounting measurements and other non-recurring charges incurred during the three months ended March 31, 2025.

NRXP also benefited by several targeted strategic initiatives which management believes will drive significant short and long-term value for shareholders including, but not limited to, progress toward the approval of our first drug product, aligning resources for an anticipated near-term commercial launch, augmenting and expanding profitable clinic operations, enhancing our overall intellectual property portfolio, and growing our development pipeline with new assets.

As of March 31, 2026, NRXP had approximately $6.7 million in cash and cash equivalents. Management believes current cash resources, anticipated growth in clinic revenue, ongoing cost reduction initiatives, and continued availability will be sufficient to support operations through 2026.

Highlights from the first quarter included:

Anticipated FDA decision on NRXP ANDA for Preservative-Free Ketamine in Q3 2026, with favorable preliminary determinations already received from the FDA Office of Generic Drugs on bioequivalence, labeling, drug product, drug substance, and safety.

Initiation of commercial manufacturing of NRXP Ketamine at the 1 million dose per month level with recent FDA inspection of the manufacturing facility and granting of inspection status consistent with launch of an ANDA drug.

Completed a Type C meeting with the FDA Division of Psychiatry Products and CDER leadership, in which the Agency expressed openness to existing clinical trial data and Real World Evidence supporting approval without additional trials.

FDA acceptance of an Investigational New Drug (IND) application for NRXP NRX-101 as an adjunct to robotic-enabled Transcranial Magnetic Stimulation (TMS), with anticipated non-dilutive federal funding supporting study at military and civilian sites.

Development of a patentable, sustained-release formulation of D-cycloserine designed to enhance TMS efficacy, building on prior trial data showing a doubling of clinical response and 8-fold increase in remission versus standard TMS.

First revenue generated from five NRXP interventional psychiatry clinics treating severe depression and PTSD, with funding from the VA, Department of War, private insurers, and self-pay; footprint expected to expand meaningfully in 2026.

Initiation of Commercial Manufacturing for Preservative Free Ketamine

On May 5th NRXP announced initiation of a first commercial manufacturing order of its preservative free ketamine product in anticipation of approval under the Generic Drug User Fee Act in Summer 2026. The order is based on stability observed in more than 3 manufactured registration batches and the NRXP successful third-party audit of the manufacturing facility.

NRXP expects that the initial manufacturing pace will be sufficient to support initial substantial yearly revenues and notes the ability to rapidly scale manufacturing as demand grows. Glenn Tyson, Chief Commercial Officer, is in the process of retaining a full commercial team.

The NRXP product is the first US-manufactured preservative-free ketamine presentation. Manufacturing is accomplished via a blow-fill-seal process that achieves more than 10-fold higher manufacturing throughput than traditional sterile bottling techniques that rely on glass vials and traditional seals.

NRXP ketamine differs from existing products in that it does not contain a known toxic preservative, Benzethonium Chloride. This preservative is no longer allowed to be included in new drugs and according to FDA policy cannot even be included in hand cleansers and topical antiseptics.

Presidential Initiative to Accelerate Approval of Psychedelic Medications to Treat Depression, PTSD, and Suicidality

On April 20th NRXP welcomed the Executive Order: ACCELERATING MEDICAL TREATMENTS FOR SERIOUS MENTAL ILLNESS, signed by President Trump on April 18, 2026. In the Order, the President notes that, “It is the policy of my Administration to accelerate innovative research models and appropriate drug approvals to increase access to psychedelic drugs that could save lives and reverse the crisis of serious mental illness in America.”

The order directs the Commissioner of the US Food and Drug Administration to provide Commissioner’s National Priority Vouchers (CNPV) to appropriate psychedelic drugs that have received a Breakthrough Therapy designation and are in accordance with the criteria of the National Priority Voucher Program. NRXP has applied for a CNPV in support of its upcoming New Drug Application for NRX-100.

The Presidential order further directs the Department of Health and Human Services and FDA to collaborate with the Department of Veterans Affairs and the Private Sector to increase clinical trial participation, data sharing, and real-world evidence generation regarding psychedelic drugs …to facilitate the timely evaluation and approval of drugs that meet standards for approval under the Federal Food, Drug, and Cosmetic Act. This aspect of the executive order is expected to facilitate NRXP proposed use of Real World Evidence and already-completed federally-funded clinical trials in support of drug approval.

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

Email: mduffy@nrxpharma.com

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Website: https://www.nrxpharma.com/