NRx Pharmaceuticals (Nasdaq:NRXP) Announces Path to New Drug Application with Real World Data and Broader Proposed Indication for NRX-100 (ketamine) Following Type C FDA Meeting
Rhea-AI Summary
NRx Pharmaceuticals (Nasdaq: NRXP) completed a Type C meeting with FDA leadership on Feb 17, 2026 and received oral guidance that supports a path to a New Drug Application for NRX-100 (preservative-free ketamine).
The company plans to combine existing adequate, well-controlled trial data with Real World Evidence from >65,000 patients and will seek a broader indication for treatment-resistant depression with suicidality. FDA preliminarily advised no additional nonclinical data or bridging studies would be required. Final meeting minutes and a finalized statistical analysis protocol for the RWE dataset are pending.
Positive
- Path to NDA based on existing trials plus Real World Evidence from >65,000 patients
- Fast Track designation supports expedited review
- FDA preliminarily advised no additional nonclinical data required
- FDA preliminarily advised no bridging studies for preservative-free formulation
Negative
- Oral guidance only; final meeting minutes are pending
- Statistical analysis protocol for the 65,000-person RWE dataset must be finalized
- Regulatory outcomes remain uncertain until an actual NDA submission and FDA review
News Market Reaction – NRXP
On the day this news was published, NRXP declined 0.28%, reflecting a mild negative market reaction. This price movement removed approximately $150K from the company's valuation, bringing the market cap to $53M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
NRXP is up 4.34% while key peers show mixed or negative moves. Only VANI screened in momentum with a 10.17% gain and no associated news, suggesting NRXP’s move is stock-specific rather than a broad biotech rotation.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Sep 29 | ANDA re-filing | Positive | +10.2% | Re-filed ANDA for KETAFREE after FDA Suitability Petition approval. |
| Aug 11 | Fast Track granted | Positive | -7.9% | FDA Fast Track designation for NRX-100 in suicidal ideation. |
| Nov 25 | Methods publication | Positive | +4.0% | Published paper on improved depression rating quality assurance. |
| May 06 | Final trial results | Positive | +45.7% | Final NRX-101 data showed superior safety vs. Lurasidone. |
| Apr 30 | Phase 2b/3 data | Positive | -27.3% | Promising NRX-101 Phase 2b/3 trial findings in bipolar depression. |
Clinical and regulatory updates often move the stock, with 3 aligned and 2 divergent reactions to past clinical trial news.
Over the past year, NRXP’s key milestones have centered on ketamine-based therapies and CNS indications. Clinical and regulatory events included Fast Track designation for NRX-100, an ANDA re-filing for preservative-free KETAFREE™, and multiple positive readouts for NRX-101. These updates produced both strong rallies and sharp declines, indicating volatile reactions. Today’s FDA Type C guidance on an NDA path for NRX-100 builds directly on this clinical and regulatory track record.
Historical Comparison
Past clinical-trial headlines for NRXP moved shares an average of 4.92%. Today’s FDA Type C guidance and broader NRX-100 indication fit within that typical reaction range.
Clinical news shows progression from Fast Track designation for NRX-100 and preservative-free ketamine filings to multiple NRX-101 readouts, now advancing toward an NDA path for NRX-100 using real-world data.
Regulatory & Risk Context
An effective S-3/A shelf dated 2025-12-12 allows NRx to offer up to $150,000,000 in various securities, including $78,644,060 carried over from a prior registration, providing ample capacity for future capital raises that could be dilutive.
Market Pulse Summary
This announcement outlines an FDA-endorsed path to an NDA for NRX-100 using existing trials plus Real World Evidence from 65,000 patients and a broader indication in treatment‑resistant depression with suicidality. Historically, NRXP’s clinical milestones have produced both strong gains and sharp pullbacks. An effective $150,000,000 shelf registration and prior going‑concern disclosures highlight financing and dilution risk as key factors to monitor alongside further FDA interactions and final meeting minutes.
Key Terms
type c guidance meeting regulatory
fast track designation regulatory
real world evidence medical
new drug application regulatory
substantial evidence of effectiveness regulatory
nonclinical data medical
bridging studies medical
AI-generated analysis. Not financial advice.
- NRx together with Osmind, Inc. conducted an in-person meeting attended by leadership of the FDA Division of Psychiatry Products and leadership of the FDA Center for Drug Evaluation and Research (CDER)
- Oral guidance received at the meeting provides a path to filing an application for New Drug Approval of NRX-100 under already-awarded Fast Track Designation based on existing clinical trial data and Real World Evidence
- Based on the guidance, NRx will seek a broader proposed indication for NRX-100 to serve patients with treatment-resistant depression who may have suicidality rather than only the subset with suicidality
WILMINGTON, Del., Feb. 17, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that it has completed an in-person Type C guidance meeting at the headquarters of the US Food and Drug Administration. The meeting was attended by leaders of the FDA Division of Psychiatry Products, the FDA Office of Neuroscience, and the FDA Center for Drug Evaluation and Research.
Based on oral guidance received at the meeting, NRx believes it has a path to filing an application for New Drug Approval of NRX-100 (preservative-free ketamine) based on Substantial Evidence of Effectiveness derived from existing data from adequate and well controlled trials together with confirmatory evidence from more than 65,000 patients identified in the Real World Evidence dataset. NRx will additionally seek a broader indication to serve patients with treatment resistant depression in the context of suicidality, rather than only the subset of patients with suicidality.
The Companies will work collaboratively with the FDA in the coming weeks to finalize the statistical analysis protocol for the full 65,000 person Real World Evidence dataset under FDA’s newly published guidance.
In preliminary comments ahead of meeting, FDA advised NRx that no additional nonclinical data would be required for review of NRx’s New Drug Application and that no bridging studies would be needed to support NRx’s preservative-free formulation compared to the currently-approved preservative-containing formulation of 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.”
Additional details will be provided upon receipt of the final meeting minutes.
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
FAQ
What did NRx (NRXP) learn from the Feb 17, 2026 Type C FDA meeting about NRX-100?
Will the NRX-100 application rely on Real World Evidence for NRXP's NDA filing?
Does the FDA require additional nonclinical or bridging studies for NRX-100 (NRXP)?
What indication will NRx (NRXP) seek for NRX-100 after the FDA meeting?
What are the next regulatory steps for NRXP before filing an NDA for NRX-100?
