NRx Pharma ketamine generic gets new FDA review date

FDA reclassifies NRx Pharmaceuticals’ preservative-free ketamine ANDA amendment as minor and sets a new November 10, 2026 GDUFA goal date.

Rhea-AI Filing Summary

NRx Pharmaceuticals, Inc. (NRXP) reports that the FDA Office of Generic Drugs has reclassified an amendment to its Abbreviated New Drug Application (ANDA) for preservative-free intravenous ketamine from a Major Amendment to a Minor Amendment. The FDA’s acknowledgement letter also set a revised GDUFA goal date of November 10, 2026, stating that the reclassified amendment will not require a substantial expenditure of FDA resources.

The company highlights this as an advance in the approval process for its preservative-free ketamine, which it describes as a strategic product intended to address drug shortages and support treatment of suicidal ideation in depression, including bipolar depression.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

Revised GDUFA goal date: November 10, 2026

1 metrics

Revised GDUFA goal date November 10, 2026 FDA goal date for the amended ANDA for preservative-free ketamine

Key Terms

Abbreviated New Drug Application (ANDA), GDUFA goal date, Fast Track Designation, Breakthrough Therapy Designation, +2 more

6 terms

Abbreviated New Drug Application (ANDA) regulatory

"amendment to its Abbreviated New Drug Application (ANDA), previously classified"

An Abbreviated New Drug Application (ANDA) is the regulatory request a company files to get approval to market a generic version of an existing prescription drug by showing it has the same active ingredient, strength, dosage form and works the same in the body without repeating full clinical trials. Think of it as proving your copy of a recipe tastes and performs the same as the original. For investors, ANDA approvals determine whether a lower‑cost competitor can enter a market, affecting sales, pricing, patent disputes and the value of both the original drug maker and the generic entrant.

GDUFA goal date regulatory

"The acknowledgement letter revised the GDUFA goal date to November 10, 2026"

Fast Track Designation regulatory

"NRX-100 has been awarded Fast Track Designation for the treatment"

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.

Breakthrough Therapy Designation regulatory

"NRX-101 has been awarded Breakthrough Therapy Designation for the treatment"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

National Priority Voucher Program regulatory

"an application for the Commissioner's National Priority Voucher Program"

clinical-stage biopharmaceutical company medical

"a clinical-stage biopharmaceutical company, today announced that it has received"

A clinical-stage biopharmaceutical company develops drugs or medical therapies that are being tested in people in formal clinical trials but do not yet have any approved, marketed products. For investors, these firms behave like prototype makers: their value depends heavily on trial results and regulatory decisions, so they can swing widely on a single study, consume cash while testing, and offer either large upside if trials succeed or big downside if they fail.

FAQ

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

What did the FDA change regarding NRx Pharmaceuticals (NRXP) preservative-free ketamine filing?

The FDA Office of Generic Drugs informed NRx Pharmaceuticals that an amendment to its Abbreviated New Drug Application (ANDA) for preservative-free ketamine was reclassified from a Major Amendment to a Minor Amendment, indicating it will not require a substantial expenditure of FDA resources.

What is the new GDUFA goal date for NRx Pharmaceuticals (NRXP)?

The FDA’s acknowledgement letter set a revised GDUFA goal date of November 10, 2026 for review of NRx Pharmaceuticals’ amended ANDA for preservative-free ketamine, following the reclassification of the amendment as a Minor Amendment.

Which NRx Pharmaceuticals (NRXP) product is affected by this FDA update?

The update concerns NRX-100, NRx Pharmaceuticals’ preservative-free intravenous ketamine, for which the company has filed an Abbreviated New Drug Application and initiated a New Drug Application for treating suicidal ideation in patients with depression, including bipolar depression.

What regulatory designations have NRX-100 and NRX-101 of NRx Pharmaceuticals (NRXP) received?

NRX-100 has been awarded Fast Track Designation for treating suicidal ideation in depression, including bipolar depression. NRX-101, an oral D-cycloserine/lurasidone combination, has received Breakthrough Therapy Designation for treating suicidal bipolar depression.

Is NRx Pharmaceuticals (NRXP) seeking any voucher related to NRX-100?

NRx Pharmaceuticals states it has initiated a New Drug Application filing for NRX-100 along with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression.

On which market is NRx Pharmaceuticals (NRXP) common stock listed?

NRx Pharmaceuticals’ common stock, par value $0.001 per share and trading under the symbol NRXP, is listed on The Nasdaq Stock Market LLC.

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

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false 0001719406 0001719406 2026-09-15 2026-09-15

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 15, 2026

NRX PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

	Delaware		001-38302		82-2844431
	(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification Number)

	1201 Orange Street, Suite 600 Wilmington, Delaware		19801
	(Address of principal executive offices)		(Zip Code)

(484)254-6134

(Registrant’s telephone number, including area code) 

Not applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.424)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act: 

Title of each class		Trading Symbol		Name of exchange on which registered
Common Stock, par value $0.001 per share		NRXP		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01. Other Events.

On September 15, 2026, NRx Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that it has received a written communication from the Director of Regulatory Operations of the FDA Office of Generic Drugs advising the Company that the amendment to its Abbreviated New Drug Application (ANDA), previously classified as a Major Amendment, has been reclassified as a Minor Amendment.

The acknowledgement letter revised the GDUFA goal date to November 10, 2026, citing that the reclassified amendment will not require a substantial expenditure of FDA resources.

A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number	Description
99.1	Press Release dated September 15, 2026
104	Cover Page Interactive Data File (embedded with the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	NRx Pharmaceuticals, Inc.
Date: September 15, 2026	By:	/s/ Jonathan Javitt
	Name:	Jonathan Javitt
	Its:	Chief Executive Officer

Exhibit 99.1

NRx Pharmaceuticals (Nasdaq: NRXP) Reports Update from the FDA Revising Previous Major Amendment to a Minor Amendment for Preservative-free Ketamine

WILMINGTON, Del., Sept. 15, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx" or the "Company"), a clinical-stage biopharmaceutical company, today announced that it has received a written communication from the Director of Regulatory Operations of the FDA Office of Generic Drugs advising the Company that the amendment to its Abbreviated New Drug Application (ANDA), previously classified as a Major Amendment, has been reclassified as a Minor Amendment.

The acknowledgement letter revised the GDUFA goal date to November 10, 2026, citing that the reclassified amendment will not require a substantial expenditure of FDA resources.

“On behalf of our patients and our shareholders, we are deeply appreciative of the speed with which FDA’s leadership has moved to advance the approval process of this strategic, drug shortage product,” said Dr. Jonathan Javitt, Chairman and CEO of NRx Pharmaceuticals.

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.

About HOPE Therapeutics

HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals (Nasdaq: NRXP), is a provider of advanced psychiatric and neurological care, specializing in evidence-based treatments for major depressive disorder, anxiety, and other complex neurological conditions. Operating out of state-of-the-art clinics, HOPE Therapeutics focuses on improving patient outcomes through the application of modern medical technologies and clinical practices. For more information, please visit www.hopetherapeutics.com.

About ZETA SURGICAL

ZETA SURGICAL is redefining the standard of care for image-guided surgery and targeted neuro-therapeutics. Its navigation and robotics platform applies advanced artificial intelligence and computer vision to enable high-accuracy image guidance across virtually any point of care in minutes, unlocking less invasive and more precise targeted therapies. The Zeta Navigation System, Zeta TMS Navigation System, and Zeta TMS Robotic System are cleared by the FDA and commercially available in the United States. For more information, please visit www.zetasurgical.com.

Media Contact -- media@zetasurgical.com

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

Filing Exhibits & Attachments

5 documents

Press Releases

• EX-99.1 EXHIBIT 99.1 9.6 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.5 KB
• EX-101 XBRL TAXONOMY EXTENSION DEFINITION LINKBASE 11.2 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 15.0 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.3 KB