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.
Loading…
Loading translation…
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
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
$2.13
Last Close
Volume
Volume 487,984 is below 20-day average of 585,031 (relative volume 0.83) ahead of this news.
normal
Technical
Shares at $2.13 are trading below the 200-day MA of $2.67, about 64.56% under the 52-week high.
NRXP was down 4.05% while peers showed mixed moves (e.g., VANI +0.79%, ABVC +0.96%, MGX -1.71%). With no peers in the momentum scanner, trading appeared more stock-specific than sector-driven.
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 05 |
Therapy partnership |
Positive | -8.0% |
Joint neuroplastic therapy clinic network targeting depression and PTSD. |
| Dec 18 |
Debt elimination |
Positive | -4.4% |
Conversion of remaining $5.4M debt into equity, leaving balance sheet debt‑free. |
| Dec 03 |
Pipeline expansion |
Positive | +6.2% |
NRX‑101 IND amended for use with TMS in suicidal depression. |
| Dec 02 |
ANDA update |
Positive | -5.0% |
FDA receipt of ANDA for KETAFREE™ with a Jul 29, 2026 goal date. |
| Dec 02 |
Corporate update call |
Neutral | -5.0% |
Announcement of conference call on clinical, regulatory and operational updates. |
Recent history shows frequent negative price reactions to ostensibly positive operational and regulatory updates, with only one of the last five news events aligning positively with sentiment.
Over the past several months, NRx reported multiple developments around its CNS pipeline and corporate structure. A Dec 2, 2025 update on KETAFREE™’s ANDA and a corporate call, plus a new NRX‑101 TMS indication and clinic network partnership, all focused on expanding depression and PTSD treatment platforms. The company also eliminated $5.4M of debt, targeting a debt‑free balance sheet. Despite these seemingly constructive steps and regulatory milestones, the stock often reacted negatively, underscoring a pattern of market skepticism around execution and financing needs that forms the backdrop for today’s NRX‑100 RWE announcement.
$150,000,000
registered capacity
An effective S-3/A shelf filed on 2025-12-12 allows NRx to offer up to $150,000,000 in various securities, with $78,644,060 carried over from a prior registration. With 0 recorded uses so far, this facility provides capacity for future capital raises that could fund NRX‑100 and NRX‑101 programs as well as general corporate purposes.
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.
fast track designation
regulatory
“NRX-100 (preservative-free ketamine) has been granted Fast Track Designation by FDA”
A “fast track designation” is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.
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.
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.
AI-generated analysis. Not financial advice.
- 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
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.
Source link
