NRx Pharmaceuticals (Nasdaq:NRXP) Announces 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

Rhea-AI Summary

NRx Pharmaceuticals (Nasdaq: NRXP) will submit real-world evidence from over 70,000 patients treated with intravenous ketamine or nasal S-ketamine to the FDA to support an Accelerated Approval application for NRX-100 (preservative-free ketamine) under Fast Track designation for treatment of suicidal ideation in depression, including bipolar depression.

The RWE, supplied by Osmind, includes nearly 1 million treatment sessions, continuous vitals, safety elements, and a prior 20,000-patient analysis showing rapid resolution of depression and suicidality.

Positive

• Fast Track designation granted by FDA for NRX-100
• Regulatory-grade RWE from 70,000 patients
• Dataset includes ~1 million treatment sessions and continuous vitals

Negative

• No FDA approval yet; company is applying for Accelerated Approval
• Primary evidence submitted is real-world data rather than new randomized trial results

Argus Jan 14 session

+0.94% close to close Open Argus

Details

News Market Reaction – NRXP

On Jan 14, the day this news came out, NRXP closed 0.94% above the previous close.

Data tracked by StockTitan Argus for the Jan 14 session.

Market Context

This announcement highlights NRx’s strategy of using real‑world evidence from more than 70,000 patie...

Analysis

This announcement highlights NRx’s strategy of using real‑world evidence from more than 70,000 patients treated with ketamine or esketamine to support Accelerated Approval of NRX‑100 under Fast Track Designation. It builds on prior NRX‑100 and KETAFREE™ regulatory steps, but comes against a balance sheet showing a $28.9 million net loss and modest $7.2 million cash. The active $150,000,000 shelf registration underscores that future capital raises, regulatory feedback, and safety/efficacy signals from this RWE will be key metrics to watch.

Key Figures

Real-world patients: 70,000 patients Preliminary subset: 20,000 patients Treatment sessions: Nearly 1,000,000 sessions +5 more

Real-world patients

70,000 patients

RWE dataset for ketamine/esketamine in depression and suicidal ideation

Preliminary subset

20,000 patients

Previously analyzed subset showing rapid resolution of depression/suicidality

Treatment sessions

Nearly 1,000,000 sessions

Osmind real-world dataset of ketamine or esketamine treatments

Suicide frequency

Every 11 minutes

Statement that an American commits suicide every 11 minutes

Net loss

$28.9 million

Net loss for nine months ended Sep 30, 2025 (10-Q)

Accumulated deficit

$307.3 million

Accumulated deficit as of Sep 30, 2025 (10-Q)

Cash and equivalents

$7.2 million

Cash position as of Sep 30, 2025 with going concern note

Shelf capacity

$150,000,000

Maximum amount under amended S-3/A shelf registration

Historical Context

5 past events · Latest: Jan 05

5 events

1. Jan 05

   Therapy partnership

   24h Move

   -8.0%

   Joint neuroplastic therapy clinic network targeting depression and PTSD.

2. Dec 18

   Debt elimination

   24h Move

   -4.4%

   Conversion of remaining $5.4M debt into equity, leaving balance sheet debt‑free.

3. Dec 03

   Pipeline expansion

   24h Move

   +6.2%

   NRX‑101 IND amended for use with TMS in suicidal depression.

4. Dec 02

   ANDA update

   24h Move

   -5.0%

   FDA receipt of ANDA for KETAFREE™ with a Jul 29, 2026 goal date.

5. Dec 02

   Corporate update call

   24h Move

   -5.0%

   Announcement of conference call on clinical, regulatory and operational updates.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

fast track designation, real-world evidence, suicidal ideation, bipolar depression, +4 more

8 terms

fast track designation regulatory

"NRX-100 (preservative-free ketamine) has been granted Fast Track Designation by FDA"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

real-world evidence medical

"Real-world evidence, consistent with FDA guidance, is supplied and generated by Osmind"

Real-world evidence is information gathered from everyday sources like patient records, insurance claims, or everyday experiences, rather than controlled experiments or clinical trials. It helps investors understand how products or policies perform in real life, providing a more complete picture of their effectiveness and value beyond official tests. This type of evidence can influence decision-making by offering insights based on actual, everyday outcomes.

suicidal ideation medical

"for treatment of suicidal ideation in patients with Depression and Bipolar Depression"

Suicidal ideation is when a person thinks about, plans, or imagines ending their own life; it ranges from fleeting thoughts to specific plans. For investors, reports of suicidal ideation matter because they can signal serious safety, regulatory, legal, workforce or reputational risks for healthcare products, services or employers—like a dashboard warning light that can prompt investigations, product changes, recalls, litigation or shifts in public trust.

bipolar depression medical

"for Treatment of Suicidal Ideation in Depression and Bipolar Depression"

Bipolar depression is the low-mood phase of bipolar disorder, when a person experiences prolonged sadness, low energy, slowed thinking, and loss of interest in daily activities; think of it as the downward swing in a mood pendulum. It matters to investors because it shapes demand for treatments, the design and outcome of clinical trials, regulatory approval chances, and long-term healthcare costs—factors that affect the commercial potential of therapies and medical companies.

accelerated approval regulatory

"in support of Accelerated Approval of NRX-100 (preservative-free ketamine)"

Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.

electroshock therapy medical

"the only FDA-approved treatment today is Electroshock Therapy"

A medical treatment that delivers brief, controlled electrical pulses to the brain to produce a short, targeted response that can relieve severe depression and other psychiatric conditions when other treatments fail. It matters to investors because it drives demand for specialized medical devices, treatment centers, training, and insurance reimbursement; changes in clinical guidelines, regulation, or public acceptance can affect revenue and risk for companies in the mental health and medical-device sectors.

de-identified data technical

"a policy shift that enables the submission of de-identified data from Osmind"

De-identified data is information that has had personal details — like names, addresses, phone numbers, and other unique identifiers — removed or changed so individuals cannot readily be identified, similar to taking name tags off a group photo. For investors, de-identification matters because it lowers legal and privacy risks and enables broader use or sale of datasets while sometimes reducing their detail and commercial value, affecting regulatory compliance and potential revenue from data-driven products.

real world dataset medical

"sharing this 70,000 patient Real World dataset in support of NRX-100 approval"

A real world dataset is a collection of information gathered from everyday use, such as medical records, insurance claims, patient registries, or data from devices and apps, rather than from tightly controlled laboratory or clinical trial settings. For investors, these datasets act like customer reviews and sales receipts for a product—showing how a drug, device, or service performs, how widely it’s adopted, and whether there are safety or effectiveness issues that could affect sales, costs, or regulatory outcomes.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• NRX-100 (preservative-free ketamine) has been granted Fast Track Designation by FDA for treatment of suicidal ideation in patients with Depression and Bipolar Depression.
• Real-world evidence, consistent with FDA guidance, is supplied and generated by Osmind using its nationwide electronic medical records-derived dataset.
• Previously presented preliminary analysis of a 20,000 patient subset documented rapid resolution of depression and suicidality with initiation of intravenous ketamine.
• Analyses suggested that clinical response to intravenous ketamine is consistent with prior randomized trial data and compares favorably to currently-approved products.
• Results from an upcoming analysis of the full 70,000 patient Real World Data set will be presented to the FDA in support of Accelerated Approval.
  

WILMINGTON, Del., Jan. 14, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that it has licensed Real World Evidence (RWE) drawn from over 70,000 patients in the United States who were treated with either intravenous ketamine or nasal S-ketamine for depression and suicidal ideation. The information is being submitted in support of NRx’s application for Accelerated Approval of NRX-100 (preservative-free ketamine) under Fast Track Designation for Treatment of Suicidal Ideation in Depression and Bipolar Depression. Currently, there is no medicine approved to treat suicidal ideation and the only FDA-approved treatment today is Electroshock Therapy.

The RWE is provided by Osmind, a leading neuropsychiatry technology and medical records platform used by clinics across the United States. Through this collaboration, Osmind is supplying regulatory-grade real-world evidence (RWE) to the US Food and Drug Administration (FDA) to support NRx’s application for Accelerated Approval of NRX-100 (preservative-free ketamine) as a treatment for suicidal ideation in depression, including bipolar depression.

Osmind offers an industry-leading real-world dataset on ketamine and esketamine with a large, diverse patient base and a comprehensive set of fit-for-purpose data variables spanning effectiveness and safety with longitudinal capture. This dataset includes nearly one million treatment sessions with ketamine or esketamine, hundreds of millions of datapoints of continuous vitals monitored during treatment, and differentiated data elements such as assessment of bladder symptoms and sedation.

A preliminary analysis of a subset of patients was presented by Osmind at the 2024 meeting of the American Society of Clinical Psychopharmacology.¹ Quantitative comparison to currently-approved products suggested a favorable clinical response. NRx is optimistic that when the full real-world dataset of over 70,000 patients is analyzed, the results will be clinically meaningful. In September 2025, FDA altered its policy to allow the submission of RWE that does not include personally-identifiable patient information, a policy shift that enables the submission of de-identified data from Osmind.

“We appreciate Osmind’s partnership in sharing this 70,000 patient Real World dataset in support of NRX-100 approval by the FDA,” said Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals. “An American commits suicide every 11 minutes and ketamine has become widely used off label as a drug that has been seen to reduce suicidal ideation in clinical trials. Ketamine has been adopted within the military and veterans communities for this purpose. As a result, only Americans whose care is paid for by the military and the Veterans Administration, along with those who can pay out of pocket, are able to access this potentially valuable medicine. Those who rely on other health insurance are generally not eligible for reimbursement. We are in the process of applying to the FDA for Accelerated Approval of NRX-100 (preservative-free ketamine) to enable broader access of this potentially life-saving medicine under appropriate medical supervision.”

About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals, Inc. (www.nrxpharma.com) is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101 (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression.

Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. The Company has reported regulatory milestones as they have been achieved but has not predicted the outcome of any future regulatory determination. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, including uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, and, among other things, liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, the Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.

For further information:
Brian Korb
Managing Partner, astr partners
(917) 653-5122
brian.korb@astrpartners.com

___________________

¹ https://www.osmind.org/blog/esketamine-and-iv-ketamine-for-major-depression

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is NRx Pharmaceuticals announcing for NRX-100 (NRXP) on January 14, 2026?

NRx will submit RWE from over 70,000 patients to the FDA to support Accelerated Approval of NRX-100 under Fast Track designation.

What does the 70,000-patient dataset for NRXP contain?

The Osmind dataset spans ~1 million ketamine/esketamine sessions, continuous vitals, safety metrics, and longitudinal effectiveness data.

How does the prior 20,000-patient analysis affect NRXP’s application?

A preliminary 20,000-patient analysis showed rapid resolution of depression and suicidality, cited as consistent with randomized trial data.

What regulatory pathway is NRx pursuing for NRX-100 (NRXP)?

NRx is seeking Accelerated Approval from the FDA for NRX-100, leveraging Fast Track designation and submitted RWE.

Will the Osmind data include patient-identifiable information for NRXP’s FDA submission?

The submission uses de-identified real-world evidence following a September 2025 FDA policy change permitting non‑PII RWE.

Does NRX-100 have FDA approval to treat suicidal ideation now (NRXP)?

No; NRx is currently applying for approval and has not received FDA approval for NRX-100.