[8-K] NRX Pharmaceuticals, Inc. Reports Material Event

Rhea-AI Filing Summary

NRx Pharmaceuticals, Inc. announced on September 24, 2025 that the U.S. Food and Drug Administration granted a Suitability Petition for the strength the company proposed for its planned single‑patient, preservative‑free ketamine product, KETAFREE™. The filing explains that currently marketed ketamine is supplied in multi‑dose vials containing the toxic preservative Benzethonium Chloride, and the granted petition permits immediate re‑filing of the company’s Abbreviated New Drug Application for KETAFREE™. The item notes the press release is furnished as Exhibit 99.1 and clarifies this disclosure is furnished, not "filed," under Exchange Act liability provisions.

Positive

• FDA granted a Suitability Petition enabling immediate re‑filing of the ANDA for KETAFREE™
• KETAFREE™ is preservative‑free, addressing the presence of Benzethonium Chloride in current multi‑dose ketamine vials

Negative

• Disclosure lacks timelines for ANDA submission, review, or potential approval
• No clinical, manufacturing, or commercial details were provided to quantify development progress or market impact

Insights

Regulatory Affairs Analyst

FDA granted a Suitability Petition, allowing ANDA re‑filing for KETAFREE™.

The granted Suitability Petition specifically clears the proposed product strength for the company’s single‑patient, preservative‑free ketamine formulation, which addresses the presence of Benzethonium Chloride in current multi‑dose vials. This removes a regulatory barrier that previously prevented submission of an Abbreviated New Drug Application for the proposed strength.

With the petition granted, the company can immediately re‑file the ANDA, which is a concrete procedural step toward potential approval if the ANDA meets FDA requirements.

Product Development Advisor

KETAFREE™ targets preservative‑free single‑patient use to avoid a toxic preservative.

The disclosure highlights a clear product differentiation: a preservative‑free single‑patient ketamine formulation versus existing multi‑dose vials containing Benzethonium Chloride. Removing that preservative could address a safety concern identified by the company.

Immediate ANDA re‑filing is a milestone for development timing, but the filing does not provide submission timelines, clinical or manufacturing details, or any guarantee of approval.

false 0001719406 0001719406 2025-09-24 2025-09-24 0001719406 nrxp:CommonStockCustomMember 2025-09-24 2025-09-24 0001719406 nrxp:WarrantsToPurchaseOneShareOfCommonStockCustomMember 2025-09-24 2025-09-24

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 24, 2025

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 No.)

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)

N/A

(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:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	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(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		NRXP		The Nasdaq Stock Market LLC
Warrants to purchase one share of Common Stock		NRXPW		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 24, 2025, NRx Pharmaceuticals, Inc. (the “Company”) issued a press release, in which the Company announced that it was notified by the United States Food and Drug Administration that a Suitability Petition has been granted for the strength proposed by the Company for its planned single-patient, preservative-free ketamine product (KETAFREE™). Currently, ketamine is sold in multi-dose vials that contain Benzethonium Chloride, a toxic preservative. The Suitability Petition that has been granted enables immediate re-filing of the Company’s Abbreviated New Drug Application for KETAFREE™. A copy of the Press Release is furnished hereto as Exhibit 99.1

The information in this Item 8.01 and in the Press Release furnished as Exhibit 99.1 to this current report shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 8.01 and in the Press Release furnished as Exhibit 99.1 to this current report shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press Release, dated September 24, 2025
104		Cover Page Interactive Data File (formatted as Inline XBRL).

SIGNATURES

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

	NRX PHARMACEUTICALS, INC.
Date: September 26, 2025	By:	/s/ Jonathan Javitt
	Name:	Jonathan Javitt
	Title:	Interim Chief Executive Officer

FAQ

What did NRXP announce about KETAFREE™ on September 24, 2025?

NRx Pharmaceuticals said the FDA granted a Suitability Petition for the proposed strength of its preservative‑free ketamine product, KETAFREE™, allowing immediate ANDA re‑filing.

What does the FDA Suitability Petition grant mean for NRXP (NRXP)?

The grant permits the company to re‑file its Abbreviated New Drug Application for the proposed strength of KETAFREE™, removing a procedural barrier to submission.

Why is a preservative‑free ketamine formulation important according to the filing?

The filing notes current ketamine multi‑dose vials contain the toxic preservative Benzethonium Chloride; KETAFREE™ is intended as a preservative‑free, single‑patient product to avoid that preservative.

Did NRX provide an ANDA submission date or approval timeline?

No. The current report states the petition was granted and that ANDA re‑filing is enabled, but it does not provide specific submission dates or review timelines.

Is the press release included in the 8‑K considered "filed" with the SEC?

No. The company explicitly states the information and the Exhibit 99.1 press release are furnished and not deemed "filed" for Section 18 liability or incorporated by reference.