By Meg Flippin, Benzinga
DETROIT, MICHIGAN - February 27, 2026 (NEWMEDIAWIRE) - NRx Pharmaceuticals, Inc. (NASDAQ: NRXP), a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system (CNS) disorders, specifically suicidal bipolar depression, chronic pain and PTSD, is making further inroads on that front.
The company just announced it completed an in-person meeting with the U.S. Food and Drug Administration (FDA) over NRX-100, its developmental drug for treating suicidal depression. NRX-100 is a preservative-free intravenous (IV) ketamine formulation. The proprietary formulation is designed to be a safer alternative to existing ketamine preparations and avoid potential toxicity associated with preservatives found in current ketamine preparations designed for anesthetic purposes, reports the company.
On The Way To New Drug Application
The Type C guidance meeting was run by leaders of the FDA Division of Psychiatry Products, the FDA Office of Neuroscience and the FDA Center for Drug Evaluation and Research. NRx said it walked away from the meeting confident it has a path to filing an application for New Drug Approval of NRX-100 based on Substantial Evidence of Effectiveness derived from existing data from trials, together with confirmatory evidence from more than 65,000 patients identified in the Real World Evidence dataset. The company said it will also seek a broader indication for NRX-100 to serve patients with treatment-resistant depression in the context of suicidality, rather than only the subset of patients with suicidality.
Approval of a New Drug Application for the treatment of depression could give NRx access to what it estimates to be a $2 billion ketamine market currently served by Intranasal S-ketamine.
“We deeply appreciate the FDA’s meeting with us at the leadership level and guiding us to pursue a New Drug Application for NRX-100 for the benefit of the millions of Americans who tragically form a plan to end their lives each year,” said Dr. Jonathan Javitt, founder, Chairman and CEO of NRx Pharmaceuticals. “Based on the guidance received, we will be using the clinical trial data already in hand together with the proposed Real World Data from Osmind, Inc., to apply for approval of a lifesaving drug to meet the needs of Americans, including Veterans and First Responders.”
Expecting Approval Of Preservative-Free Ketamine In Summer 2026
In addition to the New Drug Application in progress, NRx has filed an Abbreviated New Drug Application (ANDA) with the FDA, which was received by the agency in September 2025. NRx anticipates a summer 2026 decision date. The company reports that currently, ketamine sold worldwide typically contains a toxic preservative, benzethonium chloride, which was allowed in the 1970s when ketamine was originally marketed, but is no longer allowed today in foods or drugs because it is not generally recognized as safe. The FDA does not even allow it to be used in hand cleansers or topical antiseptics. NRx estimates that the current market for IV ketamine is worth $750 million - labelled for use as anesthesia - and the company wants to replace it with a modern, preservative-free formulation.
Bringing New Treatments To The Masses
In 2025, NRx launched its HOPE Therapeutics subsidiary, with medical clinics that combine neuroplastic drugs, such as ketamine, with Transcranial Magnetic Stimulation (TMS), Hyperbaric Oxygen Therapy and psychotherapy. Recently published scientific papers have demonstrated the significant potential of these therapies to provide relief to patients with suicidal depression and PTSD. HOPE’s initial clinics are located on the East and West Coasts of Florida, with expansion expected nationwide.
In addition to making progress with the FDA, NRx recently teamed up with neurocare group AG to provide a neuroplastic therapy, which the companies say is a new way to treat mental health issues such as depression. This approach combines specialized medication with advanced brain stimulation techniques to help the brain rewire itself and heal. Their goal is to offer a better way to treat people struggling with clinical depression and PTSD, where other methods haven’t worked. According to the companies, pilot programs have shown that combining TMS with ketamine and other neuroplastic drugs, along with hyperbaric oxygen therapy and supportive psychotherapy, has resulted in a high rate of remission among first responders with PTSD and depression. Like HOPE, neurocare has a growing clinical organization and has a footprint of 400 additional sites that have installed neurocare’s Apollo TMS device.
NRx is also getting attention from Wall Street for its HOPE Therapeutics subsidiary, which is a healthcare delivery company that is building what it says is a best-in-class network of interventional psychiatry clinics to offer ketamine, TMS and other lifesaving therapies to patients with suicidal depression and related disorders.
To enhance that unit, NRx has been making acquisitions of clinics, including the recent signing of contracts to purchase 10 interventional psychiatry clinics in California and Florida. The clinic offers a full range of treatments for suicidal depression, PTSD and other CNS disorders, with treatments including ketamine, Spravato, TMS and medication management. The acquisition should be immediately accretive to revenue and EBITDA, according to the company. It's one of the reasons D. Boral has a buy rating and $34 price target on the stock. The Wall Street firm likes the momentum the HOPE unit is seeing, as well as the developments with NRX-100 and NRX-101.
“NRx is advancing regulatory work around NRX-100, including its newly filed NDA and application for the FDA’s National Priority Voucher Program, which could add strategic optionality,” wrote the Wall Street firm. “Additional momentum for HOPE may come from rapid expansion.”
NRX-101 On Track
Then there is NRX-101, the company’s FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRX-101 is a patented, oral fixed-dose combination of two FDA-approved drugs: D-cycloserine, an NMDA receptor modulator at certain dosage ranges; and Lurasidone, a 5-HT2a receptor antagonist. Combined, the drugs target the NMDA receptor, which is critical for memory function and the formation of new thoughts in the brain. If approved by the FDA and other health regulatory agencies, the company says it would be the first medicine regimen targeted to treat severe bipolar depression in patients with both acute and sub-acute suicidal ideation or behavior (ASIB and SSIB). It is designed to help address the needs of the over 13 million Americans who seriously consider suicide each year.
Debt-Free And Focused On Growth
While NRx has been busy on the developmental front, that doesn’t mean it has been lacking on the financial front. In late December, NRx Pharmaceuticals announced it had eliminated the remaining $5.4 million in balance sheet debt. This was achieved through a strategic equity conversion with Anson Funds LLC., where the outstanding debt was swapped for common stock. This puts it in a better position as it continues to develop its drugs.
By eliminating its debt and nearing a clear FDA path for its breakthrough NMDA therapies, NRx Pharmaceuticals is furthering its mission to become a leader in delivering life-saving treatments for suicidal depression, PTSD and other diseases of the brain. To learn more, click here.
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