NRx Pharmaceuticals (NRXP) Reports Q3 Results and Advances NRX-100 and NRX-101 Regulatory Programs

About this update from Nrx Pharmaceuticals, Inc.

LOS ANGELES, CA - November 17, 2025 ( NEWMEDIAWIRE ) - NRx Pharmaceuticals (NASDAQ: NRXP) reported third-quarter 2025 results and outlined progress across its clinical programs, noting its first revenue-generating activities and key regulatory milestones for NRX-100 and NRX-101. The Company highlighted expanded Fast Track status and an active Expanded Access program for NRX-100 in suicidal depression, continued advancement of its NDA supported by large-scale real-world ketamine data, and an ANDA pathway for its preservative-free ketamine KETAFREE that remains on track for a Q2 2026 GDUFA date. NRx also noted FDA communication with no major deficiencies in its revised ANDA filing and ongoing efforts to remove benzethonium chloride from commercial ketamine formulations. For NRX-101, the Company initiated its NDA with Breakthrough Therapy Designation and rolling review, supported by real-world evidence showing that D-cycloserine more than doubles the antidepressant and antisuicidal effect of TMS. A confirmatory phase 3 trial is slated for early 2026, and the Company continues expanding its HOPE delivery platform with additional facilities planned in Florida. To view the full press release, visit https://ibn.fm/XfuD3 About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals, Inc. 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 recently filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100 (IV ketamine) with an application for the Commissioner's National Priority Voucher Program for the treatment of suicidal depression. Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: http://IBN.fm/Disclaimer Forward Looking Statements Certain statements in this article are forward-looking, as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied by these forward-looking statements and may not be indicative of future results. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, various factors beyond management's control, including the risks set forth under the heading "Risk Factors" discussed under the caption "Item 1A. Risk Factors" in Part I of the Company's most recent Annual Report on Form 10-K or any updates discussed under the caption "Item 1A. Risk Factors" in Part II of the Company's Quarterly Reports on Form 10-Q and in the Company's other filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this article in making an investment decision, which are based on information available to us on the date hereof. All parties undertake no duty to update this information unless required by law View the original release on www.newmediawire.com

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