Release Details

• In advance of November 10, 2026, GDUFA goal date, all requested changes were classified as “MINOR.”
• NRx was requested to prepare and submit labels with the proprietary name currently under review by FDA.
• NRx is currently completing final manufacturing Process Validation Runs to comply with product launch requirements.
  
  

WILMINGTON, Del., Oct. 15, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP, “NRx” or “the Company”), a biopharmaceutical company that focuses on neuroplastic therapies for depression, PTSD, and related conditions, today announces the receipt of a “DISCIPLINE REVIEW LETTER” from the US Food and Drug Administration requesting “MINOR” changes to the submitted label for NRx’s Preservative-Free Ketamine product. The letter requests that the Company submits sample labeling with the proposed proprietary product name currently under review in advance of the November 10, 2026, Abbreviated New Drug Application GDUFA goal date.

“We at NRx deeply appreciate the engagement of the FDA Office of Generic Drugs and their focus on completing review of our product by the GDUFA goal date,” said Jonathan Javitt, MD, MPH, the Company’s Chairman and CEO. “The supply of ketamine in the United States has been primarily from overseas manufacture and American hospitals and doctors have been plagued by repeated shortages of this critically important drug. We look forward to demonstrating that manufacture of drugs such as this can successfully be re-shored to the United States. We believe that making a preservative-free preparation of ketamine is important for patients and appreciate the willingness of FDA to work with us on an appropriate product name.”

About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA receptor 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 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